Pre-Transplant Information Collection

Information Collection Domain: Pre-Transplant Information Collection
Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Pre-Transplant
Essential Data

Pre-Transplant
Essential Data

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

no

no

Sequence Number:

Auto Filled Field

Sequence Number:

Auto Filled Field

no

no

Date Received:

Auto Filled Field

Date Received:

Auto Filled Field

no

no

CIBMTR Center Number:

Auto Filled Field

CIBMTR Center Number:

Auto Filled Field

no

no

EBMT Code (CIC):

Auto Filled Field

EBMT Code (CIC):

Auto Filled Field

no

no

CIBMTR Research ID:

Auto Filled Field

CIBMTR Research ID:

Auto Filled Field

no

no

Event date:

Auto Filled Field created with CRID

Event date:

Auto Filled Field created with CRID

no

no

Date of birth:

YYYY/MM/DD

Date of birth:

YYYY/MM/DD

no

no

Sex

Sex

female,male

no

no

Ethnicity

female,male
Hispanic or Latino,Not applicable (not a
resident of the USA),Not Hispanic or
Latino,Unknown

Ethnicity

Hispanic or Latino,Not applicable (not a resident
of the USA),Not Hispanic or Latino,Unknown

Race (check all that apply)

American Indian or Alaska Native,Asian,Black or
African American,Not reported,Native Hawaiian or
Other Pacific Islander,Unknown,White

Race detail (check all that apply)

African American,African (both parents born in
Africa),South Asian,American Indian, South or
Central America,Alaskan Native or Aleut,North
American Indian,Black Caribbean,Caribbean
Indian,Other White,Eastern European,Filipino
(Pilipino),Guamanian,Hawaiian,Japanese,Korean,
Mediterranean,Middle Eastern,North
American,North Coast of Africa,Chinese,Northern
European,Other Pacific Islander,Other
Black,Samoan,Black South or Central
American,Other Southeast
Asian,Unknown,Vietnamese,White
Caribbean,Western European,White South or
Central American

no

no

no

no

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Race (check all that apply)

Race detail (check all that apply)

American Indian or Alaska
Native,Asian,Black or African
American,Not reported,Native Hawaiian
or Other Pacific Islander,Unknown,White
African American,African (both parents
born in Africa),South Asian,American
Indian, South or Central America,Alaskan
Native or Aleut,North American
Indian,Black Caribbean,Caribbean
Indian,Other White,Eastern
European,Filipino
(Pilipino),Guamanian,Hawaiian,Japanese
,Korean,Mediterranean,Middle
Eastern,North American,North Coast of
Africa,Chinese,Northern European,Other
Pacific Islander,Other
Black,Samoan,Black South or Central
American,Other Southeast
Asian,Unknown,Vietnamese,White
Caribbean,Western European,White
South or Central American

Rationale for Information Collection Update

Page 1 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Pre-Transplant
Essential Data

Pre-Transplant
Essential Data

Pre-Transplant
Essential Data

Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

no

no

no

no
no

Current Information Collection Data
Element (if applicable)

Current Information Collection Data

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response
Andorra,United
Arab Option(s)

State of residence of recipient

Element Response
Information Collection update:
Andorra,United
Arab Option(s)
Emirates,Afghanistan,Antigua and
Barbuda,Anguilla,Albania,Armenia,Neth
erlands
Antilles,Angola,Antarctica,Argentina,Am
erican
Samoa,Austria,Australia,Aruba,Aland
Islands,Azerbaijan,Bosnia and
Herzegovina,Barbados,Bangladesh,Belgi
um,Burkina
Faso,Bulgaria,Bahrain,Burundi,Benin,Sai
nt Barthelemy,Bermuda,Brunei
Darussalam,Bolivia,Bonaire, Sint
Eustatius and
Saba,Brazil,Bahamas,Bhutan,Bouvet
Island,Botswana,Belarus,Belize,Canada,C
ocos (Keeling) Islands,Congo, Democratic
Republic of the,Central African
Republic,Congo, Republic of
the,Switzerland,Cote d'Ivoire,Cook
Islands,Chile,Cameroon,China,Colombia,
Costa Rica,Cuba,Cape
Verde,Curacao,Christmas
Island,Cyprus,Czech
Republic,Germany,Djibouti,Denmark,Do
minica,Dominican
Republic,Algeria,Ecuador,Estonia,Egypt,
Western
Sahara,Eritrea,Spain,Ethiopia,Finland,Fiji
Acre,Alagoas,Amapa,Amazonas,Bahia,Ce
ara,Distrito Federal,Espirito
Santo,Goias,Maranhao,Mato
Grosso,Mato Grosso do Sul,Minas
Gerais,Para,Paraiba,Parana,Pernambuco
,Piaui,Rio Grande do Norte,Rio Grande
do Sul,Rio de
Janeiro,Rondonia,Roraima,Santa
Catarina,Sao Paulo,Sergipe,Tocantins

Province or territory of residence of
recipient

Alberta,British Columbia,Manitoba,New
Brunswick,Newfoundland and
Labrador,Nova
Scotia,Nunavut,Northwest
Territories,Ontario,Prince Edward
Island,Quebec,Saskatchewan,Yukon

no

State of residence of recipient

Alaska,Alabama,Arkansas,Arizona,Califor
nia,Colorado,Connecticut,District of
Columbia,Delaware,Florida,Georgia,Haw
aii,Iowa,Idaho,Illinois,Indiana,Kansas,Ke
ntucky,Louisiana,Massachusetts,Marylan
d,Maine,Michigan,Minnesota,Missouri,
Mississippi,Montana,North
Carolina,North Dakota,Nebraska,New
Hampshire,New Jersey,New
Mexico,Nevada,New
York,Ohio,Oklahoma,Oregon,Pennsylvan
ia,Rhode Island,South Carolina,South
Dakota,Tennessee,Texas,Utah,Virginia,V
ermont,Washington,Wisconsin,West
Virginia,Wyoming

State of residence of recipient

Alaska,Alabama,Arkansas,Arizona,California,Color
ado,Connecticut,District of
Columbia,Delaware,Florida,Georgia,Hawaii,Iowa,I
daho,Illinois,Indiana,Kansas,Kentucky,Louisiana,M
assachusetts,Maryland,Maine,Michigan,Minnesot
a,Missouri,Mississippi,Montana,North
Carolina,North Dakota,Nebraska,New
Hampshire,New Jersey,New Mexico,Nevada,New
York,Ohio,Oklahoma,Oregon,Pennsylvania,Rhode
Island,South Carolina,South
Dakota,Tennessee,Texas,Utah,Virginia,Vermont,W
ashington,Wisconsin,West Virginia,Wyoming

no

NMDP Recipient ID (RID):

open text

NMDP Recipient ID (RID):

open text

no

no

no

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Country of primary residence

Country of primary residence

Emirates,Afghanistan,Antigua and
Barbuda,Anguilla,Albania,Armenia,Netherlands
Antilles,Angola,Antarctica,Argentina,American
Samoa,Austria,Australia,Aruba,Aland
Islands,Azerbaijan,Bosnia and
Herzegovina,Barbados,Bangladesh,Belgium,Burkin
a Faso,Bulgaria,Bahrain,Burundi,Benin,Saint
Barthelemy,Bermuda,Brunei
Darussalam,Bolivia,Bonaire, Sint Eustatius and
Saba,Brazil,Bahamas,Bhutan,Bouvet
Island,Botswana,Belarus,Belize,Canada,Cocos
(Keeling) Islands,Congo, Democratic Republic of
the,Central African Republic,Congo, Republic of
the,Switzerland,Cote d'Ivoire,Cook
Islands,Chile,Cameroon,China,Colombia,Costa
Rica,Cuba,Cape Verde,Curacao,Christmas
Island,Cyprus,Czech
Republic,Germany,Djibouti,Denmark,Dominica,Do
minican
Republic,Algeria,Ecuador,Estonia,Egypt,Western
Sahara,Eritrea,Spain,Ethiopia,Finland,Fiji,Falkland
Islands,Micronesia,Faroe
Islands,France,Gabon,United Kingdom (England,
Wales, Scotland, Northern
Ireland),Grenada,Georgia,French
Guiana,Guernsey,Ghana,Gibraltar,Greenland,Gam
bia,Guinea,Guadeloupe,Equatorial
Guinea,Greece,South Georgia and the South

State of residence of recipient

Acre,Alagoas,Amapa,Amazonas,Bahia,Ceara,Distrit
o Federal,Espirito Santo,Goias,Maranhao,Mato
Grosso,Mato Grosso do Sul,Minas
Gerais,Para,Paraiba,Parana,Pernambuco,Piaui,Rio
Grande do Norte,Rio Grande do Sul,Rio de
Janeiro,Rondonia,Roraima,Santa Catarina,Sao
Paulo,Sergipe,Tocantins

Province or territory of residence of
recipient

Alberta,British Columbia,Manitoba,New
Brunswick,Newfoundland and Labrador,Nova
Scotia,Nunavut,Northwest
Territories,Ontario,Prince Edward
Island,Quebec,Saskatchewan,Yukon

Rationale for Information Collection Update

Page 2 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

no

Zip or postal code for place of recipient's
residence (USA and Canada residents only): open text

yes

no

Has the recipient signed an IRB / ethics
committee (or similar body) approved
consent form to donate research blood
samples to the NMDP / CIBMTR (For
allogeneic HCTs only)?

Has the recipient signed an IRB /
ethics committee (or similar body)
approved consent form to donate
No (recipient declined),Not applicable (center not
research blood samples to the NMDP participating), Not approached,Yes (recipient
/ CIBMTR (For allogeneic HCTs only)? consented)

yes

no

Related Donors

yes

Related Donors

yes

no

Allogeneic
Recipient
Allogeneic
Recipient

Clinical Trial
Participants
Clinical Trial
Participants

Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Clinical Trial
Participants
Clinical Trial
Participants
Clinical Trial
Participants

Autologous
Transplant
Autologous
Transplant

No (recipient declined),Not applicable
(center not participating), Not
approached,Yes (recipient consented)

YYYY/MM/DD

no

Date form was signed:
Did the recipient submit a research
sample to the NMDP/CIBMTR
repository? (Related donors only)

no

Research sample recipient ID:

Research sample recipient ID:
Is the recipient participating in a
clinical trial? (clinical trial sponsors
that use CIBMTR forms to capture
outcomes data)

open text

open text

no,yes
BMT CTN,COG,Other,PIDTC,RCI
BMT,USIDNET

no,yes
BMT CTN,COG,Other,PIDTC,RCI BMT,USIDNET,
PedAL

no

Study Sponsor

yes

no

Specify other sponsor:

yes

no

Study ID Number

yes

no

yes

no

Subject ID:
open text
Specify the ClinicalTrials.gov identification
number:
open text

yes

no

Is a subsequent HCT planned as part of the
overall treatment protocol? (not as a
reaction to post-HCT disease assessment)
(For autologous HCTs only)
no,yes

Subject ID:
open text
Specify the ClinicalTrials.gov
identification number:
open text
Is a subsequent HCT planned as part
of the overall treatment protocol?
(not as a reaction to post-HCT
disease assessment) (For autologous
HCTs only)
no,yes

yes

no

Specify subsequent HCT planned

Specify subsequent HCT planned

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Allogeneic,Autologous

Study Sponsor

no,yes

yes

open
text
A Representative
list of current
response options is shown here. This list
will change on a frequent basis to
accommodate updates – changes in the
response options do not affect burden of
completing this question. BMT CTN 0301
- Aplastic Anemia,BMT CTN 0601 - Sickle
Cell Anemia,BMT CTN 0701 - Follicular
Lymphoma,BMT CTN 0702 Myeloma,BMT CTN 0801 - Chronic GVHD
Treatment,BMT CTN 0803 - Auto HCT in
HIV + Patients,RCI BMT 09 - MRD,RCI
BMT 09 - Plex,BMT CTN 0901 Myeloablative vs. RIC,BMT CTN 0902 Peri-TX Stress Mgmt,BMT CTN 0903 Allo HCT in HIV + Patients,RCI BMT 10 CBA,RCI BMT 10-CMSMDS-1,RCI BMT 11 Treo,BMT CTN 1101 - Haplo vs. Double
UCB with RIC,BMT CTN 1102 - MDS in
older patients,RCI BMT 12 - Moxe,BMT
CTN 1202 - Biomarker,BMT CTN 1203 GVHD Prophylaxis,BMT CTN 1204 HLH,BMT CTN 1205 - Easy-to-read
Consent Form (ETRIC),RCI BMT 13 TLEC,BMT CTN 1301 - CNI-Free,BMT CTN
1302 - Allo MM,BMT CTN 1401 Myeloma Vaccine,RCI BMT 145-ADS202,RCI BMT 15 - MMUD,BMT CTN 1501
- Standard Risk GVHD,BMT CTN 1502 -

Change/Clarification of Response Options

Specify other sponsor:

Study ID Number

Rationale for Information Collection Update

open text

Date form was signed:
YYYY/MM/DD
Did the recipient submit a research sample
to the NMDP/CIBMTR repository? (Related
donors only)
no,yes

Is the recipient participating in a clinical
trial? (clinical trial sponsors that use
CIBMTR forms to capture outcomes data)

Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Current Information Collection Data
Element (if applicable)

Zip or postal code for place of
recipient's residence (USA and
Canada residents only):

Pre-Transplant
Essential Data

Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Be consistent with current clinical landscape, improve
transplant outcome data

open
text
A Representative
list of current response options
is shown here. This list will change on a frequent
basis to accommodate updates – changes in the
response options do not affect burden of
completing this question.BMT CTN 0301 - Aplastic
Anemia,BMT CTN 0601 - Sickle Cell Anemia,BMT
CTN 0701 - Follicular Lymphoma,BMT CTN 0702 Myeloma,BMT CTN 0801 - Chronic GVHD
Treatment,BMT CTN 0803 - Auto HCT in HIV +
Patients,RCI BMT 09 - MRD,RCI BMT 09 - Plex,BMT
CTN 0901 - Myeloablative vs. RIC,BMT CTN 0902 Peri-TX Stress Mgmt,BMT CTN 0903 - Allo HCT in
HIV + Patients,RCI BMT 10 - CBA,RCI BMT 10CMSMDS-1,RCI BMT 11 - Treo,BMT CTN 1101 Haplo vs. Double UCB with RIC,BMT CTN 1102 MDS in older patients,RCI BMT 12 - Moxe,BMT
CTN 1202 - Biomarker,BMT CTN 1203 - GVHD
Prophylaxis,BMT CTN 1204 - HLH,BMT CTN 1205 Easy-to-read Consent Form (ETRIC),RCI BMT 13 TLEC,BMT CTN 1301 - CNI-Free,BMT CTN 1302 Allo MM,BMT CTN 1401 - Myeloma Vaccine,RCI
BMT 145-ADS-202,RCI BMT 15 - MMUD,BMT CTN
1501 - Standard Risk GVHD,BMT CTN 1502 CHAMP Aplastic Anemia,BMT CTN 1503 STRIDE2,BMT CTN 1506 - AML Maintenance
Therapy,BMT CTN 1507 - Haplo Sickle Cell,RCI BMT
16-CMS-MF,RCI BMT 16 - NTCD,RCI BMT 17CD33,RCI BMT 17-CMS-MM,RCI BMT 17-CMSSCD,RCI BMT 17 - CSIDE,BMT CTN 1703 -

Allogeneic,Autologous

Page 3 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Has the recipient ever had a prior HCT?

No,Yes

Has the recipient ever had a prior
HCT?

Specify the number of prior HCTs:
Were all prior HCTs reported to the
CIBMTR?

open text

Specify the number of prior HCTs:
Were all prior HCTs reported to the
CIBMTR?

open text

No,Unknown,Yes
YYYY/MM/DD

Date of the prior HCT:

YYYY/MM/DD

No,Yes

No,Unknown,Yes

Prior Transplant

yes

yes

Date of the prior HCT:

Prior Transplant

yes

yes

yes

yes

Date estimated
checked
Was the prior HCT performed at a different
institution?
No,Yes

Date estimated
Was the prior HCT performed at a
different institution?

checked

Prior Transplant
Prior Transplant

yes

yes

Name:

open text

Name:

open text

Prior Transplant

yes

yes

City:

open text

City:

open text

Prior Transplant

yes

yes

State:

open text

State:

open text

Prior Transplant

yes

yes

Prior Transplant

yes

yes

Country:
What was the HPC source for the prior
HCT? (check all that apply)

open text
Allogeneic - related, Allogeneic unrelated, Autologous

Country:
What was the HPC source for the
prior HCT? (check all that apply)

open text
Allogeneic - related, Allogeneic -unrelated,
Autologous

Reason for current HCT

Graft failure / insufficient hematopoietic
recovery,Insufficient chimerism,New malignancy
(including PTLD and EBV
lymphoma),Other,Persistent primary
disease,Planned subsequent HCT, per
protocol,Recurrent primary disease

Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Prior Cellular
Therapies
Prior Cellular
Therapies

Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Prior Cellular
Therapies
Prior Cellular
Therapies
Prior Cellular
Therapies
Prior Cellular
Therapies
Prior Cellular
Therapies

Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Prior Cellular
Therapies

No,Yes

no

no

Reason for current HCT

Graft failure / insufficient hematopoietic
recovery,Insufficient chimerism,New
malignancy (including PTLD and EBV
lymphoma),Other,Persistent primary
disease,Planned subsequent HCT, per
protocol,Recurrent primary disease

no

no

Date of graft failure / rejection:

YYYY/MM/DD

Date of graft failure / rejection:

YYYY/MM/DD

no

no

Date of relapse:

YYYY/MM/DD

Date of relapse:

YYYY/MM/DD

no

no

Date of secondary malignancy:

YYYY/MM/DD

Date of secondary malignancy:

YYYY/MM/DD

no

no

Specify other reason:

open text

open text

No,Unknown,Yes

Specify other reason:
Has the recipient ever had a prior
cellular therapy? (do not include
DLIs)
Were all prior cellular therapies
reported to the CIBMTR?

no

no

yes

no

Has the recipient ever had a prior cellular
therapy? (do not include DLIs)
Were all prior cellular therapies reported
to the CIBMTR?

yes

no

Date of the prior cellular therapy:

YYYY/MM/DD

Date of the prior cellular therapy:

YYYY/MM/DD

yes

no

Was the cellular therapy performed at a
different institution?

No,Yes

Was the cellular therapy performed
at a different institution?

No,Yes

yes

no

Name:

open text

Name:

open text

yes

no

City:

open text

City:

open text

yes

no

State:

open text

State:

open text

yes

no

Country:

open text

Country:

open text

yes

no

Specify the source(s) for the prior cellular
therapy (check all that apply)

Allogeneic-related,Allogeneicunrelated,Autologous

Specify the source(s) for the prior
Allogeneic-related,Allogeneiccellular therapy (check all that apply) unrelated,Autologous

no

no

Multiple donors?

no,yes

Multiple donors?

no,yes

no

no

Specify number of donors:

open text

Specify number of donors:

open text

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

No,Unknown,Yes

Rationale for Information Collection Update

No,Unknown,Yes
No,Unknown,Yes

Page 4 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Pre-Transplant
Essential Data

Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

no

yes

no

yes

Allogeneic-related donor,AllogeneicSpecify donor
unrelated donor,Autologous
Bone marrow,Other product,PBSC,Single
Specify product type (check all that apply) cord blood unit

Specify donor
Specify product type (check all that
apply)

Allogeneic-related donor,Allogeneic-unrelated
donor,Autologous
Bone marrow,Other product,PBSC,Single cord
blood unit

no

yes

Specify other product:

open text

Specify other product:

open text

yes

yes

Is the product genetically modified?

Is the product genetically modified?

No,Yes

Allogeneic Donors yes

yes

Specify the related donor type

No,Yes
HLA-matched other relative,HLAmismatched relative,HLA-identical
sibling (may include non-monozygotic
twin),Syngeneic (monozygotic twin)
Fraternal
twin,Father,Grandchild,Grandparent,Mo
ther,Maternal aunt,Maternal
cousin,Maternal uncle,Other biological
relative,Paternal aunt,Paternal
cousin,Paternal uncle,Recipient's
child,Sibling

Specify the related donor type

HLA-matched other relative,HLA-mismatched
relative,HLA-identical sibling (may include nonmonozygotic twin),Syngeneic (monozygotic twin)

open text
1 HLA antigen mismatch, greater than or
equal to 2 HLA antigen mismatch (does
include haploidentical donor)
HLA matched unrelated,HLA
mismatched unrelated

Specify other biological relative:

NMDP cord blood unit ID:
Non-NMDP unrelated donor
ID:Registry donor ID:

open text

open text

open text

Fraternal
twin,Father,Grandchild,Grandparent,Mother,Mate
rnal aunt,Maternal cousin,Maternal uncle,Other
Specify the biological relationship of biological relative,Paternal aunt,Paternal
the donor to the recipient
cousin,Paternal uncle,Recipient's child,Sibling

Allogeneic Donors yes

yes

Specify the biological relationship of the
donor to the recipient

Allogeneic Donors yes

yes

Specify other biological relative:

Allogeneic Donors yes

yes

Degree of mismatch (related donors only)

Allogeneic Donors yes

yes

Allogeneic Donors yes

yes

Allogeneic Donors yes

yes

Allogeneic Donors yes

yes

Specify unrelated donor type
Did NMDP / Be the Match facilitate the
procurement, collection, or transportation
of the product?
No,Yes
Was this donor used for any prior HCTs?
(for this recipient)
no,yes
Global Registration Identifier for Donors
(GRID)
open text

Allogeneic Donors yes

yes

NMDP cord blood unit ID:

open text

Allogeneic Donors yes

yes

Non-NMDP unrelated donor ID:

open text

Allogeneic Donors yes

yes

Non-NMDP cord blood unit ID:

open text

Allogeneic Donors yes

yes

Is the CBU ID also the ISBT DIN number?

No,Unknown,Yes

Non-NMDP cord blood unit ID:
Is the CBU ID also the ISBT DIN
number?

Allogeneic Donors yes

yes

Specify the ISBT DIN number:

open text

Specify the ISBT DIN number:

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Rationale for Information Collection Update

open text
1 HLA antigen mismatch, greater than or equal to
Degree of mismatch (related donors 2 HLA antigen mismatch (does include
only)
haploidentical donor)
HLA matched unrelated,HLA mismatched
Specify unrelated donor type
unrelated
Did NMDP / Be the Match facilitate
the procurement, collection, or
transportation of the product?
No,Yes
Was this donor used for any prior
HCTs? (for this recipient)
no,yes
Global Registration Identifier for
Donors (GRID)
open text

Change/Clarification of Information Requested

open text

Capture data accurately

No,Unknown,Yes

Page 5 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element
Response
Option(s)
(A)
Austrian
Bone Marrow
Donors,(ACB) Austrian

Allogeneic Donors yes

yes

Registry or UCB Bank ID

Element
Response
Option(s)
(A)
Austrian
Bone Marrow
Donors,(ACB) Information Collection update:
Austrian Cord Blood Registry,(ACCB)
StemCyte, Inc,(AE) Emirates Bone
Marrow Donor Registry,(AM) Armenian
Bone Marrow Donor Registry Charitable
Trust,(AOCB) University of Colorado Cord
Blood Bank,(AR) Argentine CPH Donors
Registry,(ARCB) BANCEL - Argentina Cord
Blood Bank,(AUCB) Australian Cord
Blood Registry,(AUS) Australian / New
Zealand Bone Marrow Donor Registry,(B)
Marrow Donor Program Belgium,(BCB)
Belgium Cord Blood Registry,(BG)
Bulgarian Bone Marrow Donor
Registry,(BR) INCA/REDOMO,(BSCB)
British Bone Marrow Registry - Cord
Blood,(CB) Cord Blood Registry,(CH)
Swiss BloodStem Cells - Adult
Donors,(CHCB) Swiss Blood Stem Cells Cord Blood,(CKCB) Celgene Cord Blood
Bank,(CN) China Marrow Donor Program
(CMDP),(CNCB) Shan Dong Cord Blood
Bank,(CND) Canadian Blood Services
Bone Marrow Donor Registry,(CS2)
Czech National Marrow Donor
Registry,(CSCR) Czech Stem Cells
Registry,(CY) Cyprus Paraskevaidio Bone
Marrow Donor Registry,(CY2) The Cyprus
Bone Marrow Donor Registry,(D) ZKRD -

Registry or UCB Bank ID

Cord Blood Registry,(ACCB) StemCyte, Inc,(AE)
Emirates Bone Marrow Donor Registry,(AM)
Armenian Bone Marrow Donor Registry Charitable
Trust,(AOCB) University of Colorado Cord Blood
Bank,(AR) Argentine CPH Donors Registry,(ARCB)
BANCEL - Argentina Cord Blood Bank,(AUCB)
Australian Cord Blood Registry,(AUS) Australian /
New Zealand Bone Marrow Donor Registry,(B)
Marrow Donor Program Belgium,(BCB) Belgium
Cord Blood Registry,(BG) Bulgarian Bone Marrow
Donor Registry,(BR) INCA/REDOMO,(BSCB) British
Bone Marrow Registry - Cord Blood,(CB) Cord
Blood Registry,(CH) Swiss BloodStem Cells - Adult
Donors,(CHCB) Swiss Blood Stem Cells - Cord
Blood,(CKCB) Celgene Cord Blood Bank,(CN) China
Marrow Donor Program (CMDP),(CNCB) Shan
Dong Cord Blood Bank,(CND) Canadian Blood
Services Bone Marrow Donor Registry,(CS2) Czech
National Marrow Donor Registry,(CSCR) Czech
Stem Cells Registry,(CY) Cyprus Paraskevaidio Bone
Marrow Donor Registry,(CY2) The Cyprus Bone
Marrow Donor Registry,(D) ZKRD - Zentrales
Knochenmarkspender - Register Deutschland Adult
Donors,(DCB) ZKRD - Zentrales
Knochenmarkspender - Register Deutschland Cord
Blood,(DK) The Danish Bone Marrow Donor
Registry,(DK2) Bone Marrow Donors Copenhagen
(BMDC),(DUCB) German Branch of the European

Allogeneic Donors yes

yes

Specify other Registry or UCB Bank:

open text

Specify other Registry or UCB Bank:

open text

Allogeneic Donors yes

yes

Donor date of birth

Known,Unknown

Donor date of birth

Known,Unknown

Allogeneic Donors yes

yes

Donor date of birth:

YYYY/MM/DD

Donor date of birth:

YYYY/MM/DD

Allogeneic Donors yes

yes
yes

Donor age
Donor age: Months (use only if less
than 1 years old), Years

Known,Unknown

Allogeneic Donors yes

Donor age
Known,Unknown
Donor age: Months (use only if less than 1
years old), Years
open text

Allogeneic Donors yes

yes

Allogeneic Donors yes

yes

Allogeneic Donors yes

yes

Donor sex
Specify blood type (donor) (non-NMDP
allogeneic donors only)
Specify Rh factor (donor) (non-NMDP
allogeneic donors only)

Donor sex
female,male
Specify blood type (donor) (nonNMDP allogeneic donors only)
A,AB,B,O
Specify Rh factor (donor) (non-NMDP
allogeneic donors only)
Negative,Positive

Allogeneic Donors yes

yes

Donor CMV-antibodies (IgG or Total)
(Allogeneic HCTs only)

Allogeneic Donors yes

yes

Has the donor signed an IRB / ethics
committee (or similar body) approved
consent form to donate research blood
samples to the NMDP / CIBMTR? (Related
donors only)

Allogeneic Donors yes

yes

Allogeneic Donors yes

yes

Allogeneic Donors yes
Autologous
Transplant
yes

yes
yes

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

female,male
A,AB,B,O
Negative,Positive
Indeterminate, Not applicable (cord
blood unit), Non-reactive, Not done,
Reactive

No (donor declined), Not applicable
(center not participating), Not
approached, Yes (donor consented)

open text

Donor CMV-antibodies (IgG or Total) Indeterminate, Not applicable (cord blood unit),
(Allogeneic HCTs only)
Non-reactive, Not done, Reactive
Has the donor signed an IRB / ethics
committee (or similar body)
approved consent form to donate
No (donor declined), Not applicable (center not
research blood samples to the NMDP participating), Not approached, Yes (donor
/ CIBMTR? (Related donors only)
consented)

Date form was signed:
YYYY/MM/DD
Did the donor submit a research sample to
the NMDP/CIBMTR repository? (Related
donors only)
no,yes

Date form was signed:
Did the donor submit a research
sample to the NMDP/CIBMTR
repository? (related donors only)

YYYY/MM/DD

Research sample donor ID:
Specify number of products infused from
this donor:

Research sample donor ID:
Specify number of products infused
from this donor:

open text

open text
open text

Rationale for Information Collection Update

no,yes

open text

Page 6 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Pre-Transplant
Essential Data

Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Autologous
Transplant

Autologous
Transplant
Autologous
Transplant
Autologous
Transplant
Autologous
Transplant

Pre-Transplant
Essential Data

Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

yes

yes

Specify the number of these products
intended to achieve hematopoietic
engraftment:

open text

yes

yes

What agents were used to mobilize the
autologous recipient for this HCT? (check
all that apply)

G-CSF (filgrastim, Neupogen), Pegylated
G-CSF (pegfilgrastim, Neulasta),
Plerixafor (Mozobil), Combined with
chemotherapy, Anti-CD20 (rituximab,
Rituxan), Other agent
Change/Clarification of Response Options

yes

yes

Specify other agent:

open text

yes

Name of product (gene therapy recipients) Other name

Specify other agent:
Name of product (gene therapy
recipients)

open text

yes
yes

yes
no

Specify other name:
What scale was used to determine
the recipient’s functional status?

open text

no

Specify other name:
What scale was used to determine the
recipient’s functional status?

no

Allogeneic
Recipient
Allogeneic
Recipient

no

no

no

yes

no

yes

no

no

no

Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Karnofsky Scale (recipient age ≥ 16 years)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

open text
Karnofsky,Lansky
100 Normal; no complaints; no evidence
of disease,10 Moribund; fatal process
progressing rapidly,20 Very sick;
hospitalization necessary,30 Severely
disabled; hospitalization indicated,
although death not imminent,40
Disabled; requires special care and
assistance,50 Requires considerable
assistance and frequent medical care,60
Requires occasional assistance but is
able to care for most needs,70 Cares for
self; unable to carry on normal activity
or to do active work,80 Normal activity
with effort,90 Able to carry on normal
activity

100 Fully active,10 Completely disabled,
not even passive play,20 Limited to very
passive activity initiated by others (e.g.,
TV),30 Needs considerable assistance for
quiet activity,40 Able to initiate quiet
activities,50 Considerable assistance
required for any active play; fully able to
engage in quiet play,60 Ambulatory up
to 50% of time, limited active play with
assistance / supervision,70 Both greater
restrictions of, and less time spent in,
active play,80 Restricted in strenuous
play, tires more easily, otherwise
Lansky Scale (recipient age ≥ 1 year and < active,90 Minor restriction in physically
16 years)
strenuous play
Specify blood type (of recipient) (For
allogeneic HCTs only)
A,AB,B,O
Specify Rh factor (of recipient) (For
allogeneic HCTs only)
Negative,Positive
Indeterminate,Non-reactive,Not
Recipient CMV-antibodies (IgG or Total)
done,Reactive
Has the patient been infected with COVID19 (SARS-CoV-2) based on a positive test
result at any time prior to the start of the
preparative regimen / infusion?
No,Yes
Did the patient require hospitalization for
management of COVID-19 (SARS-CoV-2)
infection?
No,Yes

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Rationale for Information Collection Update

Specify the number of these products
intended to achieve hematopoietic
engraftment:
open text
G-CSF (TBO-filgrastim, filgrastim, Granix,
Neupogen) ,GM-CSF (sargramostim, Leukine),
Pegylated G-CSF (pegfilgrastim, Neulasta),
What agents were used to mobilize Plerixafor (Mozobil), Combined with
the autologous recipient for this
chemotherapy, Anti-CD20 (rituximab, Rituxan),
HCT? (check all that apply)
Other agent

Be consistent with current clinical landscape, improve
transplant outcome data

Karnofsky Scale (recipient age ≥ 16
years)

Lansky Scale (recipient age ≥ 1 year
and < 16 years)
Specify blood type (of recipient) (For
allogeneic HCTs only)
Specify Rh factor (of recipient) (For
allogeneic HCTs only)
Recipient CMV-antibodies (IgG or
Total)
Has the patient been infected with
COVID-19 (SARS-CoV-2) based on a
positive test result at any time prior
to the start of the preparative
regimen / infusion?
Did the patient require
hospitalization for management of
COVID-19 (SARS-CoV-2) infection?

Other name

Karnofsky,Lansky

100 Normal; no complaints; no evidence of
disease,10 Moribund; fatal process progressing
rapidly,20 Very sick; hospitalization necessary,30
Severely disabled; hospitalization indicated,
although death not imminent,40 Disabled;
requires special care and assistance,50 Requires
considerable assistance and frequent medical
care,60 Requires occasional assistance but is able
to care for most needs,70 Cares for self; unable to
carry on normal activity or to do active work,80
Normal activity with effort,90 Able to carry on
normal activity

100 Fully active,10 Completely disabled, not even
passive play,20 Limited to very passive activity
initiated by others (e.g., TV),30 Needs
considerable assistance for quiet activity,40 Able
to initiate quiet activities,50 Considerable
assistance required for any active play; fully able
to engage in quiet play,60 Ambulatory up to 50%
of time, limited active play with assistance /
supervision,70 Both greater restrictions of, and
less time spent in, active play,80 Restricted in
strenuous play, tires more easily, otherwise
active,90 Minor restriction in physically strenuous
play
A,AB,B,O
Negative,Positive
Indeterminate,Non-reactive,Not done,Reactive

No,Yes

No,Yes

Page 7 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Pre-Transplant
Essential Data

Pre-Transplant
Essential Data

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

no

yes

COVID-19 Vaccine yes

yes

Was mechanical ventilation used for COVID19 (SARS-CoV-2) infection?
No,Yes
Change/Clarification of Information Requested
Was a vaccine for COVID-19 (SARS-CoV-2)
received?
No,Unknown,Yes
AstraZeneca,Johnson &
Johnson/Janssen,Moderna,Novavax,Oth
Specify vaccine brand
er (specify),Pfizer-BioNTech

COVID-19 Vaccine yes

yes

Specify other type:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
Was mechanical ventilation used
given for COVID-19 (SARS-CoV-2)
infection?
Was a vaccine for COVID-19 (SARSCoV-2) received?

No,Yes

Specify vaccine brand

No,Unknown,Yes
AstraZeneca,Johnson &
Johnson/Janssen,Moderna,Novavax,Other
(specify),Pfizer-BioNTech

Specify other type:

open text

Select dose(s) received

Booster dose,First dose (with planned second
dose) ,One dose (without planned second dose)
,Second dose,Third dose

COVID-19 Vaccine yes

yes

Select dose(s) received

open text
Booster dose,First dose (with planned
second dose) ,One dose (without
planned second dose) ,Second
dose,Third dose

COVID-19 Vaccine yes

yes

Date received:

YYYY/MM/DD

Date received:

YYYY/MM/DD

COVID-19 Vaccine yes

yes

checked

no

no

no

no

no

Date estimated
Is there a history of mechanical
ventilation? (excluding COVID-19
(SARS-CoV-2))?
Is there a history of invasive fungal
infection?
Glomerular filtration rate (GFR)
before start of preparative regimen
(pediatric only)

checked

no

Date estimated
Is there a history of mechanical
ventilation? (excluding COVID-19 (SARSCoV-2))?
Is there a history of invasive fungal
infection?
Glomerular filtration rate (GFR) before
start of preparative regimen (pediatric
only)

no

no

no

no,yes
No,Yes

Known,Unknown
__ __ __ mL/min/1.732

no

Glomerular filtration rate (GFR):

no

Does the recipient have known complex
congenital heart disease? (corrected or
uncorrected) (excluding simple ASD, VSD,
or PDA repair) (pediatric only)

no

Were there any co-existing diseases or
organ impairment present according to the
HCT comorbidity index (HCT-CI)? (Source:
Sorror, M. L. (2013). How I assess
comorbidities before hematopoietic cell
transplantation. Blood, 121(15), 28542863.)
No,Yes

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

No,Yes

Rationale for Information Collection Update
Examples added or typographical errors corrected for clarification

no,yes
No,Yes

Known,Unknown

__ __ __ mL/min/1.732
Glomerular filtration rate (GFR):
Does the recipient have known
complex congenital heart disease?
(corrected or uncorrected) (excluding
simple ASD, VSD, or PDA repair)
(pediatric only)
No,Yes
Were there any co-existing diseases
or organ impairment present
according to the HCT comorbidity
index (HCT-CI)? (Source: Sorror, M. L.
(2013). How I assess comorbidities
before hematopoietic cell
transplantation. Blood, 121(15),
2854-2863.)
No,Yes

Page 8 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Pre-Transplant
Essential Data

Comorbid
Conditions

Yes

no

Specify co-existing diseases or organ
impairment (check all that apply)

Pre-Transplant
Essential Data

Comorbid
Conditions

Yes

no

Was the recipient on dialysis immediately
prior to start of preparative regimen?

Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Comorbid
Conditions
Comorbid
Conditions
Comorbid
Conditions

Yes

no

Specify prior malignancy (check all that
apply)

Yes

no

Yes
no

Current Information Collection Data
Element Response
Option(s)
Information Collection update:
Arrhythmia
- Any history
of atrial
fibrillation or flutter, sick sinus
syndrome, or ventricular arrhythmias
requiring treatment
Cardiac -Any history of coronary artery
disease (one or more vessel-coronary
artery stenosis requiring medical
treatment, stent, or bypass graft),
congestive heart failure, myocardial
infarction, OR ejection fraction ≤ 50% on
the most recent test
Cerebrovascular disease -Any history of
transient ischemic attack, subarachnoid
hemorrhage or cerebral thrombosis,
embolism, or hemorrhage
Diabetes -Requiring treatment with
insulin or oral hypoglycemic drugs in the
last 4 weeks but not diet alone
Heart valve disease -At least a moderate
to severe degree of valve stenosis or
insufficiency as determined by Echo;
prosthetic mitral or aortic valve; or
symptomatic mitral valve prolapse
Hepatic, mild - Bilirubin > upper limit of
normal to 1.5 × upper limit of normal, or
AST/ALT > upper limit of normal to 2.5 ×
upper limit of normal at the time of
transplant OR any history of hepatitis B
or hepatitis C infection

No,Unknown,Yes
Breast cancer
Central nervous system (CNS)
malignancy (e.g., glioblastoma,
astrocytoma)
Gastrointestinal malignancy (e.g., colon,
rectum, stomach, pancreas, intestine,
esophageal)
Genitourinary malignancy (e.g., kidney,
bladder, ovary, testicle, genitalia, uterus,
cervix, prostate)
Leukemia
Lung cancer
Lymphoma (includes Hodgkin & nonHodgkin lymphoma)
MDS / MPN
Melanoma
Multiple myeloma / plasma cell disorder
(PCD)
Oropharyngeal cancer (e.g., tongue,
buccal mucosa)
Sarcoma
Thyroid cancer
Other skin malignancy (basal cell,
squamous cell)
Other hematologic malignancy
Change/Clarification of Response Options
Other solid tumor

Rationale for Information Collection Update

flutter, sick sinus syndrome, or ventricular
arrhythmias requiring treatment
Cardiac -Any history of coronary artery disease
(one or more vessel-coronary artery stenosis
requiring medical treatment, stent, or bypass
graft), congestive heart failure, myocardial
infarction, OR ejection fraction ≤ 50% on the most
recent test
Cerebrovascular disease -Any history of transient
ischemic attack, subarachnoid hemorrhage or
cerebral thrombosis, embolism, or hemorrhage
Diabetes -Requiring treatment with insulin or oral
hypoglycemic drugs in the last 4 weeks but not
diet alone
Heart valve disease -At least a moderate to severe
degree of valve stenosis or insufficiency as
determined by Echo; prosthetic mitral or aortic
valve; or symptomatic mitral valve prolapse
Hepatic, mild - Bilirubin > upper limit of normal to
1.5 × upper limit of normal, or AST/ALT > upper
limit of normal to 2.5 × upper limit of normal at
the time of transplant OR any history of hepatitis
B or hepatitis C infection
Hepatic, moderate/severe -Liver cirrhosis, bilirubin
> 1.5 × upper limit of normal, or AST/ALT > 2.5 ×
upper limit of normal
Specify co-existing diseases or organ Infection -Includes a documented infection, fever
impairment (check all that apply)
of unknown origin, or pulmonary nodules
Was the recipient on dialysis
immediately prior to start of
preparative regimen?
No,Unknown,Yes
Breast cancer
Central nervous system (CNS) malignancy (e.g.,
glioblastoma, astrocytoma)
Gastrointestinal malignancy (e.g., colon, rectum,
stomach, pancreas, intestine, esophageal)
Genitourinary malignancy (e.g., kidney, bladder,
ovary, testicle, genitalia, uterus, cervix, prostate)
Leukemia Acute myeloid leukemia
Chronic myeloid leukemia
Acute lymphoblastic leukemia
Chronic lymphoblastic leukemia
Lung cancer
Lymphoma (includes Hodgkin & non-Hodgkin
lymphoma)
MDS / MPN
Melanoma
Multiple myeloma / plasma cell disorder (PCD)
Oropharyngeal cancer (e.g., tongue, buccal
mucosa)
Sarcoma
Thyroid cancer
Other skin malignancy (basal cell, squamous cell)
Other hematologic malignancy
Other solid tumor
Specify prior malignancy (check all
Be consistent with current clinical landscape, improve
that apply)
transplant outcome data

open text

no

Specify other skin malignancy: (prior)
Specify other hematologic malignancy:
(prior)

open text

Specify other skin malignancy: (prior) open text
Specify other hematologic
malignancy: (prior)
open text

no

Specify other solid tumor: (prior)

open text

Specify other solid tumor: (prior)

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Deletion of Information Requested

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response
Option(s)
Arrhythmia
- Any history
of atrial fibrillation or

Reduce redundancy in data capture

open text

Page 9 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Pre-Transplant
Essential Data

Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Pre-Transplant
Essential Data

Prior Solid Organ
Transplant
Prior Solid Organ
Transplant
Prior Solid Organ
Transplant

Current Information Collection Data
Element Response Option(s)
Information Collection update:

no

no

no

Serum ferritin (within 4 weeks prior to the
  ___ ___ ___ ___ ___ ng/mL (μg/L)
start of the preparative regimen, use result
closest to the start date)

no

no

Date sample collected:

YYYY/MM/DD

no

Upper limit of normal for your institution:

open text

no

no

Serum albumin (within 4 weeks prior to
the start of the preparative regimen, use
result closest to the start date)

Known,Unknown

no

Serum albumin (within 4 weeks prior to
the start of the preparative regimen, use
result closest to the start date)

___ ___ ● __g/dL
___ ___ ● __ g/L

no
no

no

Date sample collected:

YYYY/MM/DD

no

no

Platelets (within 4 weeks prior to the start
of the preparative regimen, use result
closest to the start date)
Known,Unknown

no

Pre-Transplant
Essential Data

Current Information Collection Data
Element (if applicable)

Serum ferritin (within 4 weeks prior to the
start of the preparative regimen, use result
closest to the start date)
Known,Unknown

no

Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

no

no

no

no

no

no

yes

yes

Specify organ

No,Yes
Bowel,Heart,Kidney(s),Liver,Lung,Other
organ,Pancreas

yes

yes

Specify other organ:

open text

yes

yes

no

no

Year of prior solid organ transplant:
YYYY
Height at initiation of pre-HCT preparative ___ ___ ___ inches
regimen:
___ ___ ___ cms
___ ___ ___ . ___pounds
___ ___ ___ . ___kilograms

no

no

Actual weight at initiation of pre-HCT
preparative regimen:

Pre-HCT Preparative
Regimen

no

no

Was a pre-HCT preparative regimen
prescribed?

Pre-HCT Preparative Allogeneic
Regimen
Recipient

yes

no

Classify the recipient’s prescribed
Myeloablative,Non-myeloablative
preparative regimen (Allogeneic HCTs only) (NST),Reduced intensity (RIC)

Pre-HCT Preparative
Regimen

no

no

no,yes

Pre-HCT Preparative
Regimen

no

no

Was irradiation planned as part of the preHCT preparative regimen?
no,yes
Total body by intensity-modulated
radiation therapy
(IMRT),Thoracoabdominal region,Total
What was the prescribed radiation field? body,Total lymphoid or nodal regions

Pre-HCT Preparative
Regimen

no

no

___ ___ ___ ___ . ___ Gy
Total prescribed dose: (dose per fraction x
___ ___ ___ ___ . ___ cGy
total number of fractions)

Rationale for Information Collection Update

Known,Unknown
  ___

___ ___ ___ ___ ng/mL (μg/L)

Date sample collected:
Upper limit of normal for your
institution:
Serum albumin (within 4 weeks prior
to the start of the preparative
regimen, use result closest to the
start date)
Serum albumin (within 4 weeks prior
to the start of the preparative
regimen, use result closest to the
start date)

YYYY/MM/DD

Date sample collected:

YYYY/MM/DD

open text

Known,Unknown
___ ___ ● __g/dL
___ ___ ● __ g/L

Platelets (within 4 weeks prior to the
start of the preparative regimen, use
result closest to the start date)
Known,Unknown
Platelets (within 4 weeks prior to the
start of the preparative regimen, use
result closest to the start date)
Were platelets transfused < 7 days
before date of test?
Did the recipient have a prior solid
organ transplant?

No,Unknown,Yes

Pre-HCT Preparative
Regimen

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Serum ferritin (within 4 weeks prior
to the start of the preparative
regimen, use result closest to the
start date)
Serum ferritin (within 4 weeks prior
to the start of the preparative
regimen, use result closest to the
start date)

___ ___ ___ ___ ___ ___ ___ x 109/L (x
103/mm3)
___ ___ ___ ___ ___ ___ ___ x 106/L

Platelets (within 4 weeks prior to the start
of the preparative regimen, use result
closest to the start date)
Were platelets transfused < 7 days before
date of test?
Did the recipient have a prior solid organ
transplant?

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Change/Clarification of Response Options

___ ___ ___ ___ ___ ___ ___ x 109/L (x 103/mm3)
___ ___ ___ ___ ___ ___ ___ x 106/L

No,Unknown,Yes

Specify organ

No,Yes
Bowel,Heart,Kidney(s),Liver,Lung,Other
organ,Pancreas

Specify other organ:

open text

Year of prior solid organ transplant:
Height at initiation of pre-HCT
preparative regimen:

YYYY

___ ___ ___ inches
___ ___ ___ cms

Capture data accurately

___ ___ ___ . ___pounds
Actual weight at initiation of pre-HCT
___ ___ ___ . ___kilograms
preparative regimen:
Was a pre-HCT preparative regimen
prescribed?
no,yes
Classify the recipient’s prescribed
preparative regimen (Allogeneic HCTs Myeloablative,Non-myeloablative (NST),Reduced
only)
intensity (RIC)
Was irradiation planned as part of
the pre-HCT preparative regimen?

no,yes

What was the prescribed radiation
field?

Total body by intensity-modulated radiation
therapy (IMRT),Thoracoabdominal region,Total
body,Total lymphoid or nodal regions

Total prescribed dose: (dose per
fraction x total number of fractions)

___ ___ ___ ___ . ___ Gy
___ ___ ___ ___ . ___ cGy

Page 10 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Pre-HCT Preparative
Regimen

no

no

Date started:

YYYY/MM/DD

Date started:

YYYY/MM/DD

Pre-HCT Preparative
Regimen

no

no

Was the radiation fractionated?

no,yes

Was the radiation fractionated?

no,yes

Pre-HCT Preparative
Regimen

no

no

Total number of fractions:

Total number of fractions:

Pre-HCT Preparative
Regimen

no

no

Drug (drop down list)

open text
Bendamustine,Busulfan,Carboplatin,Car
mustine,Clofarabine,Cyclophosphamide,
Cytarabine,Etoposide,Fludarabine,Gemci
tabine,Ibritumomab
tiuxetan,Ifosfamide,Lomustine,Melphala
n,Methylprednisolone,Other,Pentostatin
,Propylene glycol-free
melphalan,Rituximab,Thiotepa,Tositumo
mab,Treosulfan
Change/Clarification of Response Options

open text
Bendamustine,Busulfan,Carboplatin,Carmustine,Cl
ofarabine,Cyclophosphamide,Cytarabine,Etoposid
e,Fludarabine,Gemcitabine,Ibritumomab
tiuxetan,Ifosfamide,Lomustine,Melphalan,Methyl
prednisolone,Other,Pentostatin,Propylene glycolfree
melphalan,Rituximab,Thiotepa,Tositumomab,Treo
sulfan, Azathioprine, Bortezomib, Cisplatin,
Be consistent with current clinical landscape, improve
Hydroxyurea, and Vincristine.
transplant outcome data

Pre-HCT Preparative
Regimen

no

yes

Specify other drug:

Specify other drug:

Pre-HCT Preparative
Regimen

no

yes

Total prescribed dose:

open text
__ __ __ __ __. __ mg/m2
__ __ __ __ __. __mg/kg
__ __ __ __ __. __AUC (mg x h/L)
__ __ __ __ __. __AUC (µmol x min/L)
__ __ __ __ __. __CSS (ng/mL)

Total prescribed dose:

open text
__ __ __ __ __. __ mg/m2
__ __ __ __ __. __mg/kg
__ __ __ __ __. __AUC (mg x h/L)
__ __ __ __ __. __AUC (µmol x min/L)
__ __ __ __ __. __CSS (ng/mL)

Pre-HCT Preparative
Regimen

no

yes

Date started:

YYYY/MM/DD

Date started:

YYYY/MM/DD

no

yes

Specify administration (busulfan only)

Both,IV,Oral

Specify administration (busulfan
only)

Both,IV,Oral

Pre-HCT Preparative
Regimen
Additional Drugs
Given In the PeriTransplant Period
Additional Drugs
Given In the PeriTransplant Period
Additional Drugs
Given In the PeriTransplant Period
Additional Drugs
Given In the PeriTransplant Period
Additional Drugs
Given In the PeriTransplant Period
Additional Drugs
Given In the PeriTransplant Period
Additional Drugs
Given In the PeriTransplant Period
Additional Drugs
Given In the PeriTransplant Period
Additional Drugs
Given In the PeriTransplant Period
GVHD Prophylaxis

no,yes

Change/Clarification of Information Requested and
Response Option

Drug (drop down list)

ALG, ALS, ATG, ATS, Alemtuzumab,
Defibrotide, KGF, Ursodiol

no

no

ALG, ALS, ATG, ATS

no

no

Total prescribed dose:

no

no

Specify source

ATGAM (horse),ATG - Fresenius
(rabbit),Other,Thymoglobulin (rabbit)

Specify source

ATGAM (horse),ATG - Fresenius
(rabbit),Other,Thymoglobulin (rabbit)

no

no

Specify other source:

open text

Specify other source:

open text

no

no

Alemtuzumab (Campath)

Deletion of Information: Merged to Check all that Apply

Alemtuzumab (Campath)

no

no

Total prescribed dose:

no,yes
__ __ __ __ . _ mg/m2
__ __ __ __ __ . __mg/kg
__ __ __ __ __ . __mg/kg

Total prescribed dose:

no,yes
__ __ __ __ . _ mg/m2
__ __ __ __ __ . __mg/kg
__ __ __ __ __ . __mg/kg

no

no

Defibrotide

No,Yes

Deletion of Information: Merged to Check all that Apply

Defibrotide

No,Yes

no

no

KGF

No,Yes

Deletion of Information: Merged to Check all that Apply

KGF

No,Yes

no

no

Ursodiol

No,Yes

Deletion of Information: Merged to Check all that Apply

Ursodiol

No,Yes

yes

no

Was GVHD prophylaxis planned?

No,Yes

Was GVHD prophylaxis planned?

No,Yes

__ __ __ __ __ mg/kg

Allogeneic
Recipient

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

no,yes (check all that apply)

Rationale for Information Collection Update

Reduce burden: expanded response options to include
responses previously reported manually or created a "check
all that apply"

__ __ __ __ __ mg/kg
Total prescribed dose:

Reduce burden: expanded response options to include
responses previously reported manually or created a "check
all that apply"

Reduce burden: expanded response options to include
responses previously reported manually or created a "check
all that apply"
Reduce burden: expanded response options to include
responses previously reported manually or created a "check
all that apply"
Reduce burden: expanded response options to include
responses previously reported manually or created a "check
all that apply"

Page 11 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

GVHD Prophylaxis
GVHD Prophylaxis
Post-HCT Disease
Therapy Planned as
of Day 0

Post-HCT Disease
Therapy Planned as
of Day 0
Post-HCT Disease
Therapy Planned as
of Day 0

Allogeneic
Recipient
Allogeneic
Recipient

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

yes

no

Abatacept,Anti CD 25(Zenapax,
Daclizumab, AntiTAC),Blinded
randomized trial,Bortezomib,CD34
enriched(CD34+
selection),Corticosteriods
(systemic),Cyclophosphamide
(Cytoxan),Cyclosporine (CSA, Neoral,
Sandimmune),Extra-corporeal
photopheresis (ECP),Ex-vivo T-cell
depletion,Filgotinib,Maraviroc,Mycophe
nolate mofetil (MMF)
(Cellcept),Methotrexate (MTX)
(Amethopterin),Other
agent,Ruxolitinib,Sirolimus (Rapamycin,
Specify drugs / intervention (check all that Rapamune),Tacrolimus(FK
apply)
506),Tocilizumab

Abatacept,Anti CD 25(Zenapax, Daclizumab,
AntiTAC),Blinded randomized
trial,Bortezomib,CD34 enriched(CD34+
selection),Corticosteriods
(systemic),Cyclophosphamide
(Cytoxan),Cyclosporine (CSA, Neoral,
Sandimmune),Extra-corporeal photopheresis
(ECP),Ex-vivo T-cell
depletion,Filgotinib,Maraviroc,Mycophenolate
mofetil (MMF) (Cellcept),Methotrexate (MTX)
(Amethopterin),Other agent,Ruxolitinib,Sirolimus
Specify drugs / intervention (check all (Rapamycin, Rapamune),Tacrolimus(FK
that apply)
506),Tocilizumab

yes

no

Specify other agent:

open text (do not report ATG, campath)

Specify other agent:

open text (do not report ATG, campath)

no

no

Is additional post-HCT therapy planned?

no,yes

Is additional post-HCT therapy
planned?

no,yes

Azacitidine(Vidaza),Blinatumomab,Borte
zomib
(Velcade),Bosutinib,Brentuximab,Carfilz
omib,Cellular therapy (e.g. DCI,
DLI),Crenolanib,Daratumumab,Dasatinib
,Decitabine,Elotuzumab,Enasidenib,Gilte
ritinib,Ibrutinib,Imanitib mesylate
(Gleevec, Glivec),Intrathecal
chemotherapy,Ivosidenib,Ixazomib,Lenal
idomide (Revlimid),Lestaurtinib,Local
radiotherapy,Midostaurin,Nilotinib,Obin
utuzumab,Other,Pacritinib,Ponatinib,Qu
izartinib,Rituximab (Rituxan,
Mabthera),Sorafenib,Sunitinib,Thalidomi
de (Thalomid),Unknown

Specify post-HCT therapy planned

Azacitidine(Vidaza),Blinatumomab,Bortezomib
(Velcade),Bosutinib,Brentuximab,Carfilzomib,Cellu
lar therapy (e.g. DCI,
DLI),Crenolanib,Daratumumab,Dasatinib,Decitabin
e,Elotuzumab,Enasidenib,Gilteritinib,Ibrutinib,Ima
nitib mesylate (Gleevec, Glivec),Intrathecal
chemotherapy,Ivosidenib,Ixazomib,Lenalidomide
(Revlimid),Lestaurtinib,Local
radiotherapy,Midostaurin,Nilotinib,Obinutuzumab
,Other,Pacritinib,Ponatinib,Quizartinib,Rituximab
(Rituxan,
Mabthera),Sorafenib,Sunitinib,Thalidomide
(Thalomid),Unknown

Specify other therapy:

open text

Blinatumomab(Blincyto),Gemtuzumab ozogamicin
(Mylotarg),Inotuzumab ozogamicin (Besponsa)
,Mogamulizumab (Poteligeo) ,None,Thiotepa

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

no

no

Specify post-HCT therapy planned

no

no

Specify other therapy:

Prior Exposure:
Potential Study
Eligibility

no

no

Covid-19 Impact

no

no

Addition of Information Requested

Covid-19 Impact

no

no

Addition of Information Requested

Specify if the recipient received any
of the following (at any time prior to
HCT / infusion) (check all that apply)
Was the HCT impacted for a reason
related to the COVID-19 (SARS-CoV2) pandemic?
Is the HCT date different than the
originally intended HCT date?

Covid-19 Impact

no

no

Addition of Information Requested

Original Date of HCT

Covid-19 Impact

no

no

Addition of Information Requested

Covid-19 Impact

no

no

Addition of Information Requested

Date estimated
Is the donor different than the
originally intended donor?

Covid-19 Impact

no

no

Addition of Information Requested

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

open text
Blinatumomab(Blincyto),Gemtuzumab
ozogamicin (Mylotarg),Inotuzumab
Specify if the recipient received any of the ozogamicin (Besponsa)
following (at any time prior to HCT /
,Mogamulizumab (Poteligeo)
infusion) (check all that apply)
,None,Thiotepa

Rationale for Information Collection Update

no,yes

Covid-19 Impact

no,yes

Covid-19 Impact

YYYY/MM/DD

Covid-19 Impact

checked

Covid-19 Impact

no,yes
Covid-19 Impact
unrelated donor, syngeneic (monozygotic twin) ,
HLA-idential sibling (may include non-monozygotic
twin) , HLA-matched other relative (does NOT
include a haplo-identical donor), HLA-mismatched
Specify the originally intended donor relative
Covid-19 Impact

Page 12 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Covid-19 Impact

no

no

Addition of Information Requested

Covid-19 Impact

no

no

Addition of Information Requested

Covid-19 Impact

no

no

Addition of Information Requested

Covid-19 Impact

no

no

Addition of Information Requested

Covid-19 Impact

no

no

Addition of Information Requested

Covid-19 Impact
Disease
Classification

no

no

Disease
Classification

no

no

yes

no

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Addition of Information Requested
Date of diagnosis of primary disease for
HCT / cellular therapy:

YYYY/MM/DDdiseases,Acute
Autoimmune
lymphoblastic leukemia (ALL),Acute
myelogenous leukemia (AML or
ANLL),Chronic myelogenous leukemia
(CML),Hemoglobinopathies,Histiocytic
disorders,Hodgkin lymphoma,Inherited
Bone Marrow Failure Syndromes(If the
recipient developed MDS or AML,
indicate MDS or AML as the primary
disease.)– ,Disorders of the immune
system,Inherited disorders of
metabolism,Inherited abnormalities of
platelets,Myelodysplastic syndrome
(MDS) (If recipient has transformed to
AML, indicate AML as the primary
disease.),Myeloproliferative neoplasms
(MPN)(If recipient has transformed to
AML, indicate AML as the primary
disease.),Non-Hodgkin lymphoma,Acute
leukemia of ambiguous lineage and
other myeloid neoplasms,Other
disease,Other leukemia (includes
CLL),Multiple myeloma / plasma cell
disorder (PCD),Paroxysmal nocturnal
hemoglobinuria (PNH),Recessive
dystrophic epidermolysis
bullosa,Aplastic Anemia(If the recipient
What was the primary disease for which
developed MDS or AML, indicate MDS or
the HCT / cellular therapy was performed? AML as the primary disease.) ,Solid
Change/Clarification of Response Options

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Rationale for Information Collection Update

Is the product type (bone marrow,
PBSC, cord blood unit) different than
the originally intended product type? no,yes
Covid-19 Impact
Specify the originally intended
product type
bone marrow,Other product,PBSC, cord blood unit Covid-19 Impact
Specify other product type
Was the current product thawed
from a cryopreserved state prior to
infusion?
Did the preparative regimen change
from the original plan?
Did the GVHD prophylaxis change
from the original plan?
Date of diagnosis of primary disease
for HCT / cellular therapy:

open text

Covid-19 Impact

no,yes

Covid-19 Impact

no, yes

Covid-19 Impact

no,yes

Covid-19 Impact

YYYY/MM/DD

Autoimmune diseases,Acute lymphoblastic
leukemia (ALL),Acute myelogenous myeloid
leukemia (AML or ANLL),Chronic myelogenous
leukemia (CML),Hemoglobinopathies,Histiocytic
disorders,Hodgkin lymphoma,Inherited Bone
Marrow Failure Syndromes(If the recipient
developed MDS or AML, indicate MDS or AML as
the primary disease.)– ,Disorders of the immune
system,Inherited disorders of
metabolism,Inherited abnormalities of
platelets,Myelodysplastic syndrome (MDS) (If
recipient has transformed to AML, indicate AML as
the primary disease.),Myeloproliferative
neoplasms (MPN)(If recipient has transformed to
AML, indicate AML as the primary disease.),NonHodgkin lymphoma,Acute leukemia of ambiguous
lineage and other myeloid neoplasms,Other
disease,Other leukemia (includes CLL),Multiple
myeloma / plasma cell disorder (PCD),Paroxysmal
nocturnal hemoglobinuria (PNH),Recessive
dystrophic epidermolysis bullosa,Aplastic
Anemia(If the recipient developed MDS or AML,
What was the primary disease for
indicate MDS or AML as the primary disease.)
which the HCT / cellular therapy was ,Solid tumors,Tolerance induction associated with
performed?
solid organ transplant
Capture data accurately

Page 13 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

yes

no

Current Information Collection Data
Element (if applicable)

Current Information Collection Data

Specify the AML classification

Specify the AML classification

AML with t(9;11) (p22.3;q23.3); MLLT3-KMT2A (5),
AML with t(6;9) (p23;q34.1); DEK-NUP214 (6),
AML with inv(3) (q21.3;q26.2) or t(3;3)
(q21.3;q26.2); GATA2, MECOM (7),
AML (megakaryoblastic) with t(1;22)
(p13.3;q13.3); RBM15-MKL1 (8),
AML with t(8;21); (q22; q22.1); RUNX1-RUNX1T1
(281),
AML with inv(16) (p13.1;1q22) or t(16;16)(p13.1;
q22); CBFB-MYH11 (282),
APL with PML-RARA (283),
AML with BCR-ABL1 (provisional entity) (3),
AML with mutated NPM1 (4),
AML with biallelic mutations of CEBPA (297),
AML with mutated RUNX1 (provisional entity)
(298),
AML with 11q23 (MLL) abnormalities (i.e., t(4;11),
t(6;11), t(9;11), t(11;19)) (284),
AML with myelodysplasia – related changes (285),
Therapy related AML (t-AML) (9),
AML, not otherwise specified:
AML, not otherwise specified (280),
AML, minimally differentiated (286),
AML without maturation (287) ,
AML with maturation (288) ,
Acute myelomonocytic leukemia (289),
Acute monoblastic / acute monocytic leukemia
(290),

Did AML transform from MDS or
MPN?

no,yes-Also complete MDS or MPN Disease
Classification questions

Is the disease (AML) therapy related? no,Unknown,yes

yes

no

Did AML transform from MDS or MPN?

no,yes-Also complete MDS or MPN
Disease Classification questions

yes

no

Is the disease (AML) therapy related?

no,Unknown,yes

yes

no

Did the recipient have a predisposing
condition?

yes

no

Specify condition

no,Unknown,yes
Bloom syndrome,Dyskeratosis
congenita,Down Syndrome,Fanconi
anemia,Other condition

yes

no

Specify other condition:

open text

yes

yes

Were cytogenetics tested (karyotyping or
FISH)? (at diagnosis)

no,Unknown,yes

yes

yes

Were cytogenetics tested via FISH?

No,Yes

yes

yes

yes

yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

yes

Specify number of distinct cytogenetic
abnormalities

yes

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element
Option(s)
AML
withResponse
recurrent genetic
abnormalities:

Element
Option(s)
Information Collection update:
AML
withResponse
recurrent genetic
abnormalities:
AML with t(9;11) (p22.3;q23.3); MLLT3KMT2A (5),
AML with t(6;9) (p23;q34.1); DEKNUP214 (6),
AML with inv(3) (q21.3;q26.2) or t(3;3)
(q21.3;q26.2); GATA2, MECOM (7),
AML (megakaryoblastic) with t(1;22)
(p13.3;q13.3); RBM15-MKL1 (8),
AML with t(8;21); (q22; q22.1); RUNX1RUNX1T1 (281),
AML with inv(16) (p13.1;1q22) or
t(16;16)(p13.1; q22); CBFB-MYH11 (282),
APL with PML-RARA (283),
AML with BCR-ABL1 (provisional entity)
(3),
AML with mutated NPM1 (4),
AML with biallelic mutations of CEBPA
(297),
AML with mutated RUNX1 (provisional
entity) (298),
AML with 11q23 (MLL) abnormalities
(i.e., t(4;11), t(6;11), t(9;11), t(11;19))
(284),
AML with myelodysplasia – related
changes (285),
Therapy related AML (t-AML) (9),
AML, not otherwise specified:

Did the recipient have a predisposing
condition?
no,Unknown,yes

Specify condition

Bloom syndrome,Dyskeratosis congenita,Down
Syndrome,Fanconi anemia,Other condition

Specify other condition:
Were cytogenetics tested
(karyotyping or FISH)? (at diagnosis
or relapse)

open text

Were cytogenetics tested via FISH?

No,Yes

Abnormalities identified,No abnormalities

open text

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

Four or more (4 or more),One (1),Three
(3),Two (2)

Specify number of distinct
cytogenetic abnormalities

Abnormalities identified,No
abnormalities

Rationale for Information Collection Update

Change/Clarification of Information Requested

no,Unknown,yes

Reduce redundancy in data capture

open text

Four or more (4 or more),One (1),Three (3),Two (2)

Page 14 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)

Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

yes

yes

(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) /
16q-,del(17q) / 17q-,del(20q) / 20q,del(21q) / 21q-,del(3q) / 3q-,del(5q) / 5q,del(7q) / 7q-,del(9q) / 9q-,inv(16),inv(3),17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;
Specify abnormalities (check all that apply) 11),t(9;22),+11,+13,+14,+21,+22,+4,+8

yes

yes

Specify other abnormality:

yes

yes

Were cytogenetics tested via karyotyping? No,Yes

yes

yes

yes

yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

yes

yes

Specify number of distinct cytogenetic
abnormalities

open text

Abnormalities identified,No
abnormalities,No evaluable metaphases

yes

yes

yes

yes

Specify other abnormality:

open text

yes

yes

Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)

No,Yes

yes

yes

Were tests for molecular markers
performed? (at diagnosis)

no,Unknown,yes

yes

yes

CEBPA

Negative,Not Done,Positive

(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) / 16q,del(17q) / 17q-,del(20q) / 20q-,del(21q) / 21q,del(3q) / 3q-,del(5q) / 5q-,del(7q) / 7q-,del(9q) /
9q-,inv(16),inv(3),-17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
Specify abnormalities (check all that variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;11),t(9;22)
apply)
,+11,+13,+14,+21,+22,+4,+8

Specify other abnormality:

open text

Were cytogenetics tested via
karyotyping?

No,Yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

open text

Four or more (4 or more),One (1),Three
(3),Two (2)
(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) /
16q-,del(17q) / 17q-,del(20q) / 20q,del(21q) / 21q-,del(3q) / 3q-,del(5q) / 5q,del(7q) / 7q-,del(9q) / 9q-,inv(16),inv(3),17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;
Specify abnormalities (check all that apply) 11),t(9;22),+11,+13,+14,+21,+22,+4,+8

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Specify number of distinct
cytogenetic abnormalities

Specify other abnormality:
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)

Abnormalities identified,No abnormalities,No
evaluable metaphases

open text

Four or more (4 or more),One (1),Three (3),Two (2)

(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) / 16q,del(17q) / 17q-,del(20q) / 20q-,del(21q) / 21q,del(3q) / 3q-,del(5q) / 5q-,del(7q) / 7q-,del(9q) /
9q-,inv(16),inv(3),-17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
Specify abnormalities (check all that variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;11),t(9;22)
apply)
,+11,+13,+14,+21,+22,+4,+8

Change/Clarification of Information Requested

open text

No,Yes

Were tests for molecular markers
performed? (at diagnosis or relapse) no,Unknown,yes

CEBPA

Negative,Not Done,Positive

Specify CEBPA mutation

Biallelic (double mutant),Monoallelic (single
mutant),Unknown

yes

yes

Specify CEBPA mutation

Biallelic (homozygous),Monoallelic
(heterozygous),Unknown

yes

yes

FLT3 - TKD (point mutations in D835 or
deletions of codon I836)

Negative,Not done,Positive

FLT3 - TKD (point mutations in D835
or deletions of codon I836)
Negative,Not done,Positive

yes

yes

FLT3 – ITD mutation

Negative,Not Done,Positive

FLT3 – ITD mutation

Negative,Not Done,Positive

yes

yes

FLT3 - ITD allelic ratio

Known,Unknown

FLT3 - ITD allelic ratio

Known,Unknown

Change/Clarification of Response Options

__ __ . __ __
yes

yes

Specify FLT3 - ITD allelic ratio:

yes

yes

IDH1

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Rationale for Information Collection Update

Reduce redundancy in data capture

Capture data accurately

__ __ . __ __
Specify FLT3 - ITD allelic ratio:

Negative,Not Done,Positive

IDH1

Negative,Not Done,Positive

Page 15 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)

Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

yes

yes

IDH2

Negative,Not Done,Positive

IDH2

Negative,Not Done,Positive

yes

yes

KIT

Negative,Not Done,Positive

KIT

Negative,Not Done,Positive

yes

yes

NPM1

Negative,Not Done,Positive

NPM1

Negative,Not Done,Positive

yes

yes

Other molecular marker

Negative,Not Done,Positive

Other molecular marker

Negative,Not Done,Positive

yes

yes

Specify other molecular marker:

open text

open text

yes

yes

Were cytogenetics tested (karyotyping or
FISH)? (between diagnosis and last
evaluation)

no,Unknown,yes

Specify other molecular marker:
Were cytogenetics tested
(karyotyping or FISH)? (between
diagnosis or relapse and last
evaluation)

yes

yes

Were cytogenetics tested via FISH?

No,Yes

Were cytogenetics tested via FISH?

No,Yes

yes

yes

yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

Abnormalities identified,No abnormalities

yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

yes

yes

Specify number of distinct cytogenetic
abnormalities

Abnormalities identified,No
abnormalities

open text

yes

yes

Four or more (4 or more),One (1),Three
(3),Two (2)
(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) /
16q-,del(17q) / 17q-,del(20q) / 20q,del(21q) / 21q-,del(3q) / 3q-,del(5q) / 5q,del(7q) / 7q-,del(9q) / 9q-,inv(16),inv(3),17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;
Specify abnormalities (check all that apply) 11),t(9;22),+11,+13,+14,+21,+22,+4,+8

yes

yes

Specify other abnormality:

yes

yes

Were cytogenetics tested via karyotyping? No,Yes

yes

yes

yes

yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

yes

Specify number of distinct cytogenetic
abnormalities

yes

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

open text

Abnormalities identified,No
abnormalities,No evaluable metaphases

Change/Clarification of Information Requested

no,Unknown,yes

Rationale for Information Collection Update

Reduce redundancy in data capture

open text

Specify number of distinct
cytogenetic abnormalities

Specify other abnormality:

open text

Were cytogenetics tested via
karyotyping?

No,Yes

Four or more (4 or more),One (1),Three (3),Two (2)

(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) / 16q,del(17q) / 17q-,del(20q) / 20q-,del(21q) / 21q,del(3q) / 3q-,del(5q) / 5q-,del(7q) / 7q-,del(9q) /
9q-,inv(16),inv(3),-17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
Specify abnormalities (check all that variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;11),t(9;22)
apply)
,+11,+13,+14,+21,+22,+4,+8

open text

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

Four or more (4 or more),One (1),Three
(3),Two (2)

Specify number of distinct
cytogenetic abnormalities

Abnormalities identified,No abnormalities,No
evaluable metaphases

open text

Four or more (4 or more),One (1),Three (3),Two (2)

Page 16 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Disease
Classification
Disease
Classification
Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

yes

yes

(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) /
16q-,del(17q) / 17q-,del(20q) / 20q,del(21q) / 21q-,del(3q) / 3q-,del(5q) / 5q,del(7q) / 7q-,del(9q) / 9q-,inv(16),inv(3),17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;
Specify abnormalities (check all that apply) 11),t(9;22),+11,+13,+14,+21,+22,+4,+8

yes

yes

Specify other abnormality:

open text

yes

yes

Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)

No,Yes

yes

yes

Were tests for molecular markers
performed? (e.g. PCR, NGS) (between
diagnosis and last evaluation)

no,Unknown,yes

yes

yes

CEBPA

Negative,Not Done,Positive

yes

yes

Specify CEBPA mutation

Biallelic (homozygous),Monoallelic
(heterozygous),Unknown

yes

yes

FLT3 - TKD (point mutations in D835 or
deletions of codon I836)

Negative,Not done,Positive

FLT3 - TKD (point mutations in D835
or deletions of codon I836)
Negative,Not done,Positive

yes

yes

FLT3 – ITD mutation

Negative,Not Done,Positive

FLT3 – ITD mutation

Negative,Not Done,Positive

yes

yes

FLT3 - ITD allelic ratio

Known,Unknown

FLT3 - ITD allelic ratio

Known,Unknown

yes

yes

Specify FLT3 - ITD allelic ratio:

yes

yes

IDH1

Negative,Not Done,Positive

IDH1

Negative,Not Done,Positive

yes

yes

IDH2

Negative,Not Done,Positive

IDH2

Negative,Not Done,Positive

yes

yes

KIT

Negative,Not Done,Positive

KIT

Negative,Not Done,Positive

yes

yes

NPM1

Negative,Not Done,Positive

NPM1

Negative,Not Done,Positive

yes

yes

Other molecular marker

Negative,Not Done,Positive

Other molecular marker

Negative,Not Done,Positive

yes

yes

Specify other molecular marker:

open text

open text

yes

yes

Were cytogenetics tested (karyotyping or
FISH)? (at last evaluation)

no,Unknown,yes

Specify other molecular marker:
Were cytogenetics tested
(karyotyping or FISH)? (at last
evaluation)

yes

yes

Were cytogenetics tested via FISH?

No,Yes

Were cytogenetics tested via FISH?

No,Yes

(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) / 16q,del(17q) / 17q-,del(20q) / 20q-,del(21q) / 21q,del(3q) / 3q-,del(5q) / 5q-,del(7q) / 7q-,del(9q) /
9q-,inv(16),inv(3),-17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
Specify abnormalities (check all that variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;11),t(9;22)
apply)
,+11,+13,+14,+21,+22,+4,+8

Change/Clarification of Information Requested

Change/Clarification of Response Options

Specify other abnormality:
open text
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)
No,Yes
Were tests for molecular markers
performed? (e.g. PCR, NGS) (between
diagnosis or relapse and last
evaluation)
no,Unknown,yes

CEBPA

Negative,Not Done,Positive

Specify CEBPA mutation

Biallelic (double mutant),Monoallelic (single
mutant),Unknown

__ __ . __ __

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Rationale for Information Collection Update

Reduce redundancy in data capture

Capture data accurately

__ __ . __ __
Specify FLT3 - ITD allelic ratio:

no,Unknown,yes

Page 17 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)

Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)

Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

yes

yes

yes

yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

yes

yes

Specify number of distinct cytogenetic
abnormalities

Current Information Collection Data
Element Response Option(s)
Information Collection update:
Abnormalities identified,No
abnormalities

yes

yes

yes

yes

Specify other abnormality:

yes

yes

Were cytogenetics tested via karyotyping? No,Yes

yes

yes

yes

yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

yes

Specify number of distinct cytogenetic
abnormalities

Abnormalities identified,No
abnormalities,No evaluable metaphases

yes

yes

yes

Specify other abnormality:

Abnormalities identified,No abnormalities

open text

Specify number of distinct
cytogenetic abnormalities

Specify other abnormality:

open text

Were cytogenetics tested via
karyotyping?

No,Yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

open text

yes

Four or more (4 or more),One (1),Three (3),Two (2)

Abnormalities identified,No abnormalities,No
evaluable metaphases

open text

Specify number of distinct
cytogenetic abnormalities

open text

no,Unknown,yes

Specify other abnormality:
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)
Were tests for molecular markers
performed?(e.g. PCR, NGS) (at last
evaluation)

CEBPA

Negative,Not Done,Positive

Specify CEBPA mutation

Biallelic (double mutant),Monoallelic (single
mutant),Unknown

Four or more (4 or more),One (1),Three (3),Two (2)

(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) / 16q,del(17q) / 17q-,del(20q) / 20q-,del(21q) / 21q,del(3q) / 3q-,del(5q) / 5q-,del(7q) / 7q-,del(9q) /
9q-,inv(16),inv(3),-17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
Specify abnormalities (check all that variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;11),t(9;22)
apply)
,+11,+13,+14,+21,+22,+4,+8

open text

yes

yes

yes

yes

Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)
Were tests for molecular markers
performed?(e.g. PCR, NGS) (at last
evaluation)

yes

yes

CEBPA

Negative,Not Done,Positive

yes

yes

Specify CEBPA mutation

Biallelic (homozygous),Monoallelic
(heterozygous),Unknown

yes

yes

FLT3 - TKD (point mutations in D835 or
deletions of codon I836)

Negative,Not done,Positive

FLT3 - TKD (point mutations in D835
or deletions of codon I836)
Negative,Not done,Positive

yes

yes

FLT3 – ITD mutation

Negative,Not Done,Positive

FLT3 – ITD mutation

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Rationale for Information Collection Update

(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) / 16q,del(17q) / 17q-,del(20q) / 20q-,del(21q) / 21q,del(3q) / 3q-,del(5q) / 5q-,del(7q) / 7q-,del(9q) /
9q-,inv(16),inv(3),-17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
Specify abnormalities (check all that variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;11),t(9;22)
apply)
,+11,+13,+14,+21,+22,+4,+8

open text

Four or more (4 or more),One (1),Three
(3),Two (2)
(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) /
16q-,del(17q) / 17q-,del(20q) / 20q,del(21q) / 21q-,del(3q) / 3q-,del(5q) / 5q,del(7q) / 7q-,del(9q) / 9q-,inv(16),inv(3),17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;
Specify abnormalities (check all that apply) 11),t(9;22),+11,+13,+14,+21,+22,+4,+8

yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

open text

Four or more (4 or more),One (1),Three
(3),Two (2)
(11q23) any abnormality,12p any
abnormality,del(11q) / 11q-,del(16q) /
16q-,del(17q) / 17q-,del(20q) / 20q,del(21q) / 21q-,del(3q) / 3q-,del(5q) / 5q,del(7q) / 7q-,del(9q) / 9q-,inv(16),inv(3),17,-18,-5,-7,-X,-Y,Other
abnormality,t(15;17) and
variants,t(16;16),t(3;3),t(6;9),t(8;21),t(9;
Specify abnormalities (check all that apply) 11),t(9;22),+11,+13,+14,+21,+22,+4,+8

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

No,Yes

Change/Clarification of Response Options

No,Yes

no,Unknown,yes

Capture data accurately

Negative,Not Done,Positive

Page 18 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Disease
Classification

Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)

Disease
Classification

Acute
Myelogenous
Leukemia (AML)

Disease
Classification

Acute
Myelogenous
Leukemia (AML)

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

yes

yes

FLT3 - ITD allelic ratio

Known,Unknown

FLT3 - ITD allelic ratio

Known,Unknown

yes

yes

Specify FLT3 - ITD allelic ratio:

__ __ . __ __

Specify FLT3 - ITD allelic ratio:

__ __ . __ __

yes

yes

IDH1

Negative,Not Done,Positive

IDH1

Negative,Not Done,Positive

yes

yes

IDH2

Negative,Not Done,Positive

IDH2

Negative,Not Done,Positive

yes

yes

KIT

Negative,Not Done,Positive

KIT

Negative,Not Done,Positive

yes

yes

NPM1

Negative,Not Done,Positive

NPM1

Negative,Not Done,Positive

yes

yes

Other molecular marker

Negative,Not Done,Positive

Other molecular marker

Negative,Not Done,Positive

yes

yes

Specify other molecular marker:

open text

no

Did the recipient have central nervous
system leukemia at any time prior to the
start of the preparative regimen / infusion? no,Unknown,yes

Specify other molecular marker:
open text
Did the recipient have central
nervous system leukemia at any time
prior to the start of the preparative
regimen / infusion?
no,Unknown,yes

yes

1st complete remission,1st relapse,2nd
complete remission,2nd relapse,≥ 3rd
complete remission, ≥3rd relapse,No
treatment,Primary induction failure

What was the disease status?

How many cycles of induction
therapy were required to achieve 1st
complete remission? (includes CRi) 1,2, ≥ 3

Rationale for Information Collection Update

1st complete remission,1st relapse,2nd complete
remission,2nd relapse,≥ 3rd complete remission,
≥3rd relapse,No treatment,Primary induction
failure

no

What was the disease status?

no

How many cycles of induction therapy
were required to achieve 1st complete
remission? (includes CRi)

1,2, ≥ 3

yes

no

Was the recipient in remission by flow
cytometry?

Not applicable,No,Unknown,Yes

yes

no

Addition of Information Requested

Was the recipient in remission by
flow cytometry?
Specify method(s) that was used to
assess measurable residual disease
status (check all that apply)

yes

no

Addition of Information Requested

Was measurable residual disease
detected by FISH?

no,yes

Be consistent with current clinical landscape, improve
transplant outcome data

yes

no

Addition of Information Requested

Was measurable residual disease
detected by karyotyping assay?

no,yes

Be consistent with current clinical landscape, improve
transplant outcome data

yes

no

Addition of Information Requested

yes

no

yes

yes

yes

yes

Deletion of Information Requested

Not applicable,No,Unknown,Yes

Reduce redundancy in data capture

FISH, Karyotyping, Flow Cytometry, PCR, NGS, Not Be consistent with current clinical landscape, improve
assessed
transplant outcome data

Be consistent with current clinical landscape, improve
transplant outcome data

Addition of Information Requested

Which leukemia phenotype was used original leukemia immunophenotype, aberrant
for detection (check all the apply)
phenotype
What is the lower limit of detection
(for the original leukemia
immunophenotype)
open text

no

Addition of Information Requested

What is the lower limit of detection
(for the aberrant phenotype)

open text

Be consistent with current clinical landscape, improve
transplant outcome data

no

Addition of Information Requested

Was measurable residual disease
detected by flow cytometry?

no,yes

Be consistent with current clinical landscape, improve
transplant outcome data

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Be consistent with current clinical landscape, improve
transplant outcome data

Page 19 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)
Acute
Myelogenous
Leukemia (AML)

Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)

Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Rationale for Information Collection Update

yes

no

Addition of Information Requested

Was measurable residual disease
detected by PCR?

no,yes

Be consistent with current clinical landscape, improve
transplant outcome data

yes

no

Addition of Information Requested

Was measurable residual disease
detected by NGS?

no,yes

Be consistent with current clinical landscape, improve
transplant outcome data

yes

no

Date of most recent relapse:

YYYY/MM/DD

Date of most recent relapse:

YYYY/MM/DD

yes

no

Date assessed:

Date assessed:

yes

no

Specify ALL classification

YYYY/MM/DD
B-lymphoblastic leukemia / lymphoma:
B-lymphoblastic leukemia / lymphoma,
NOS (B-cell ALL, NOS) (191),
B-lymphoblastic leukemia / lymphoma
with t(9;22)(q34.1;q11.2); BCR-ABL1
(192),
B-lymphoblastic leukemia / lymphoma
with t(v;11q23.3); KMT2A rearranged
(193),
B-lymphoblastic leukemia / lymphoma
with t(1;19)(q23;p13.3); TCF3-PBX1
(194),
B-lymphoblastic leukemia / lymphoma
with t(12;21) (p13.2;q22.1); ETV6RUNX1 (195),
B-lymphoblastic leukemia / lymphoma
with t(5;14) (q31.1;q32.3); IL3-IGH (81),
B-lymphoblastic leukemia / lymphoma
with Hyperdiploidy (51-65
chromosomes) (82),
B-lymphoblastic leukemia / lymphoma
with Hypodiploidy (<46 chromosomes)
(83),
B-lymphoblastic leukemia / lymphoma,
BCR-ABL1-like (provisional entity) (94),
B-lymphoblastic leukemia / lymphoma,
with iAMP21 (95),
T-cell lymphoblastic leukemia /
lymphoma:

YYYY/MM/DD
B-lymphoblastic leukemia / lymphoma:
B-lymphoblastic leukemia / lymphoma, NOS (B-cell
ALL, NOS) (191),
B-lymphoblastic leukemia / lymphoma with
t(9;22)(q34.1;q11.2); BCR-ABL1 (192),
B-lymphoblastic leukemia / lymphoma with
t(v;11q23.3); KMT2A rearranged (193),
B-lymphoblastic leukemia / lymphoma with
t(1;19)(q23;p13.3); TCF3-PBX1 (194),
B-lymphoblastic leukemia / lymphoma with
t(12;21) (p13.2;q22.1); ETV6-RUNX1 (195),
B-lymphoblastic leukemia / lymphoma with
t(5;14) (q31.1;q32.3); IL3-IGH (81),
B-lymphoblastic leukemia / lymphoma with
Hyperdiploidy (51-65 chromosomes) (82),
B-lymphoblastic leukemia / lymphoma with
Hypodiploidy (<46 chromosomes) (83),
B-lymphoblastic leukemia / lymphoma, BCR-ABL1like (provisional entity) (94),
B-lymphoblastic leukemia / lymphoma, with
iAMP21 (95),
T-cell lymphoblastic leukemia / lymphoma:
T-cell lymphoblastic leukemia / lymphoma
(Precursor T-cell ALL) (196),
Early T-cell precursor lymphoblastic leukemia
(96),NK cell lymphoblastic leukemia / lymphoma:
Natural killer (NK)- cell lymphoblastic leukemia /
lymphoma (97)

yes

no

Did the recipient have a predisposing
condition?

yes

no

Specify condition

no,Unknown,yes
Aplastic anemia,Bloom syndrome,Down
Syndrome,Fanconi anemia,Other
condition

yes

no

Specify other condition:

open text

yes

no

Were tyrosine kinase inhibitors given for
therapy at any time prior to the start of the
preparative regimen / infusion? (e.g.
imatinib mesylate, dasatinib, etc.)
no,yes

yes

yes

Were cytogenetics tested (karyotyping or
FISH)? (at diagnosis)

no,Unknown,yes

yes

yes

Were cytogenetics tested via FISH?

No,Yes

Were cytogenetics tested via FISH?

No,Yes

Results of tests

Abnormalities identified,No
abnormalities

Results of tests

Abnormalities identified,No abnormalities

yes

yes

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Specify ALL classification

Did the recipient have a predisposing
condition?
no,Unknown,yes

Specify condition

Change/Clarification of Information Requested

Aplastic anemia,Bloom syndrome,Down
Syndrome,Fanconi anemia,Other condition

Specify other condition:
open text
Were tyrosine kinase inhibitors given
for therapy at any time prior to the
start of the preparative regimen /
infusion? (e.g. imatinib mesylate,
dasatinib, etc.)
no,yes
Were cytogenetics tested
(karyotyping or FISH)? (at diagnosis
or relapse)
no,Unknown,yes

Reduce redundancy in data capture

Page 20 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)

Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)

Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

yes

yes

International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

yes

yes

Specify number of distinct cytogenetic
abnormalities

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

open text

International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

open text

Specify number of distinct
cytogenetic abnormalities

Four or more (4 or more),One (1),Three (3),Two (2)

Specify other abnormality:

open text

Were cytogenetics tested via
karyotyping?

No,Yes

yes

yes

Four or more (4 or more),One (1),Three
(3),Two (2)
(11q23) any abnormality,12p any
abnormality,9p any
abnormality,add(14q),del(12p) / 12p,del(6q) / 6q-,del(9p) / 9p-,Hyperdiploid
(> 50),Hypodiploid (< 46),iAMP21,7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(1
2;21),t(2;8),t(4;11),t(5;14),t(8;14),t(8;22)
Specify abnormalities (check all that apply) ,t(9;22),+17,+21,+4,+8

yes

yes

Specify other abnormality:

(11q23) any abnormality,12p any abnormality,9p
any abnormality,add(14q),del(12p) / 12p-,del(6q) /
6q-,del(9p) / 9p-,Hyperdiploid (> 50),Hypodiploid
(< 46),iAMP21,-7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(12;21),t(2;8
Specify abnormalities (check all that ),t(4;11),t(5;14),t(8;14),t(8;22),t(9;22),+17,+21,+4,
apply)
+8

open text

yes

yes

Were cytogenetics tested via karyotyping? No,Yes

yes

yes

yes

yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

yes

yes

Specify number of distinct cytogenetic
abnormalities

Abnormalities identified,No
abnormalities,No evaluable metaphases

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

open text

Specify number of distinct
cytogenetic abnormalities

Abnormalities identified,No abnormalities,No
evaluable metaphases

open text

yes

yes

Four or more (4 or more),One (1),Three
(3),Two (2)
(11q23) any abnormality,12p any
abnormality,9p any
abnormality,add(14q),del(12p) / 12p,del(6q) / 6q-,del(9p) / 9p-,Hyperdiploid
(> 50),Hypodiploid (< 46),iAMP21,7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(1
2;21),t(2;8),t(4;11),t(5;14),t(8;14),t(8;22)
Specify abnormalities (check all that apply) ,t(9;22),+17,+21,+4,+8

yes

yes

Specify other abnormality:

open text

yes

yes

Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)

No,Yes

Specify other abnormality:
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)

yes

yes

Were tests for molecular markers
performed? (at diagnosis)

no,Unknown,yes

Were tests for molecular markers
performed? (at diagnosis or relapse) no,Unknown,yes

yes

yes

BCR / ABL

Negative,Not Done,Positive

BCR / ABL

Negative,Not Done,Positive

yes

yes

TEL-AML / AML1

Negative,Not Done,Positive

TEL-AML / AML1

Negative,Not Done,Positive

yes

yes

Other molecular marker

Negative,Not Done,Positive

Other molecular marker

Negative,Not Done,Positive

yes

yes

Specify other molecular marker:

open text

Specify other molecular marker:

open text

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Rationale for Information Collection Update

Four or more (4 or more),One (1),Three (3),Two (2)

(11q23) any abnormality,12p any abnormality,9p
any abnormality,add(14q),del(12p) / 12p-,del(6q) /
6q-,del(9p) / 9p-,Hyperdiploid (> 50),Hypodiploid
(< 46),iAMP21,-7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(12;21),t(2;8
Specify abnormalities (check all that ),t(4;11),t(5;14),t(8;14),t(8;22),t(9;22),+17,+21,+4,
apply)
+8

Change/Clarification of Information Requested

open text

No,Yes

Reduce redundancy in data capture

Page 21 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification

Disease
Classification
Disease
Classification

Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)

Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)

Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

yes

yes

Were cytogenetics tested (karyotyping or
FISH)? (between diagnosis and last
evaluation)

yes

yes

Were cytogenetics tested via FISH?

yes

yes

yes

yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

yes

yes

Specify number of distinct cytogenetic
abnormalities

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Rationale for Information Collection Update

no,Unknown,yes

Were cytogenetics tested
(karyotyping or FISH)? (between
diagnosis or at relapse and last
evaluation)

no,Unknown,yes

Reduce redundancy in data capture

No,Yes

Were cytogenetics tested via FISH?

No,Yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

Abnormalities identified,No abnormalities

Abnormalities identified,No
abnormalities

open text

yes

yes

Four or more (4 or more),One (1),Three
(3),Two (2)
(11q23) any abnormality,12p any
abnormality,9p any
abnormality,add(14q),del(12p) / 12p,del(6q) / 6q-,del(9p) / 9p-,Hyperdiploid
(> 50),Hypodiploid (< 46),iAMP21,7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(1
2;21),t(2;8),t(4;11),t(5;14),t(8;14),t(8;22)
Specify abnormalities (check all that apply) ,t(9;22),+17,+21,+4,+8

yes

yes

Specify other abnormality:

yes

yes

Were cytogenetics tested via karyotyping? No,Yes

yes

yes

yes

yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

yes

Specify number of distinct cytogenetic
abnormalities

Abnormalities identified,No
abnormalities,No evaluable metaphases

yes

yes

yes

Specify other abnormality:

open text

yes

yes

Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)

No,Yes

yes

yes

Were tests for molecular markers
performed? (e.g. PCR, NGS) (between
diagnosis and last evaluation)

no,Unknown,yes

yes

yes

BCR / ABL

Negative,Not Done,Positive

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Specify number of distinct
cytogenetic abnormalities

Specify other abnormality:

open text

Were cytogenetics tested via
karyotyping?

No,Yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

open text

yes

open text

Four or more (4 or more),One (1),Three (3),Two (2)

(11q23) any abnormality,12p any abnormality,9p
any abnormality,add(14q),del(12p) / 12p-,del(6q) /
6q-,del(9p) / 9p-,Hyperdiploid (> 50),Hypodiploid
(< 46),iAMP21,-7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(12;21),t(2;8
Specify abnormalities (check all that ),t(4;11),t(5;14),t(8;14),t(8;22),t(9;22),+17,+21,+4,
apply)
+8

open text

Four or more (4 or more),One (1),Three
(3),Two (2)
(11q23) any abnormality,12p any
abnormality,9p any
abnormality,add(14q),del(12p) / 12p,del(6q) / 6q-,del(9p) / 9p-,Hyperdiploid
(> 50),Hypodiploid (< 46),iAMP21,7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(1
2;21),t(2;8),t(4;11),t(5;14),t(8;14),t(8;22)
Specify abnormalities (check all that apply) ,t(9;22),+17,+21,+4,+8

yes

Change/Clarification of Information Requested

Abnormalities identified,No abnormalities,No
evaluable metaphases

open text

Specify number of distinct
cytogenetic abnormalities

Specify other abnormality:
open text
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)
No,Yes
Were tests for molecular markers
performed? (e.g. PCR, NGS) (between
diagnosis or relapse and last
evaluation)
no,Unknown,yes

Four or more (4 or more),One (1),Three (3),Two (2)

(11q23) any abnormality,12p any abnormality,9p
any abnormality,add(14q),del(12p) / 12p-,del(6q) /
6q-,del(9p) / 9p-,Hyperdiploid (> 50),Hypodiploid
(< 46),iAMP21,-7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(12;21),t(2;8
Specify abnormalities (check all that ),t(4;11),t(5;14),t(8;14),t(8;22),t(9;22),+17,+21,+4,
apply)
+8

Change/Clarification of Information Requested

BCR / ABL

Reduce redundancy in data capture

Negative,Not Done,Positive

Page 22 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification

Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)

Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)

Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

yes

yes

TEL-AML / AML1

Negative,Not Done,Positive

TEL-AML / AML1

Negative,Not Done,Positive

yes

yes

Other molecular marker

Negative,Not Done,Positive

Other molecular marker

Negative,Not Done,Positive

yes

yes

Specify other molecular marker:

open text

open text

yes

yes

Were cytogenetics tested (karyotyping or
FISH)? (at last evaluation)

no,Unknown,yes

Specify other molecular marker:
Were cytogenetics tested
(karyotyping or FISH)? (at last
evaluation)

yes

yes

Were cytogenetics tested via FISH?

No,Yes

Were cytogenetics tested via FISH?

No,Yes

yes

yes

yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

Abnormalities identified,No abnormalities

yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

yes

yes

Specify number of distinct cytogenetic
abnormalities

Abnormalities identified,No
abnormalities

open text

yes

yes

Four or more (4 or more),One (1),Three
(3),Two (2)
(11q23) any abnormality,12p any
abnormality,9p any
abnormality,add(14q),del(12p) / 12p,del(6q) / 6q-,del(9p) / 9p-,Hyperdiploid
(> 50),Hypodiploid (< 46),iAMP21,7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(1
2;21),t(2;8),t(4;11),t(5;14),t(8;14),t(8;22)
Specify abnormalities (check all that apply) ,t(9;22),+17,+21,+4,+8

yes

yes

Specify other abnormality:

yes

yes

Were cytogenetics tested via karyotyping?
(at last evaluation)
No,Yes

yes

yes

yes

yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

yes

Specify number of distinct cytogenetic
abnormalities

open text

Abnormalities identified,No
abnormalities,No evaluable metaphases

open text

yes

yes

Four or more (4 or more),One (1),Three
(3),Two (2)
(11q23) any abnormality,12p any
abnormality,9p any
abnormality,add(14q),del(12p) / 12p,del(6q) / 6q-,del(9p) / 9p-,Hyperdiploid
(> 50),Hypodiploid (< 46),iAMP21,7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(1
2;21),t(2;8),t(4;11),t(5;14),t(8;14),t(8;22)
Specify abnormalities (check all that apply) ,t(9;22),+17,+21,+4,+8

yes

yes

Specify other abnormality:

open text

yes

yes

Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)

No,Yes

yes

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Rationale for Information Collection Update

no,Unknown,yes

open text

Specify number of distinct
cytogenetic abnormalities

Specify other abnormality:

open text

Were cytogenetics tested via
karyotyping? (at last evaluation)

No,Yes

Four or more (4 or more),One (1),Three (3),Two (2)

(11q23) any abnormality,12p any abnormality,9p
any abnormality,add(14q),del(12p) / 12p-,del(6q) /
6q-,del(9p) / 9p-,Hyperdiploid (> 50),Hypodiploid
(< 46),iAMP21,-7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(12;21),t(2;8
Specify abnormalities (check all that ),t(4;11),t(5;14),t(8;14),t(8;22),t(9;22),+17,+21,+4,
apply)
+8

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Specify number of distinct
cytogenetic abnormalities

Specify other abnormality:
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)

Abnormalities identified,No abnormalities,No
evaluable metaphases

open text

Four or more (4 or more),One (1),Three (3),Two (2)

(11q23) any abnormality,12p any abnormality,9p
any abnormality,add(14q),del(12p) / 12p-,del(6q) /
6q-,del(9p) / 9p-,Hyperdiploid (> 50),Hypodiploid
(< 46),iAMP21,-7,Other
abnormality,t(1;19),t(10;14),t(11;14),t(12;21),t(2;8
Specify abnormalities (check all that ),t(4;11),t(5;14),t(8;14),t(8;22),t(9;22),+17,+21,+4,
apply)
+8

open text

No,Yes

Page 23 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Disease
Classification

Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)

Disease
Classification

Acute
Lymphoblastic
Leukemia (ALL)

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)
Acute
Lymphoblastic
Leukemia (ALL)

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

yes

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

yes

Were tests for molecular markers
performed? (e.g. PCR, NGS) (at last
evaluation)

no,Unknown,yes

Were tests for molecular markers
performed? (e.g. PCR, NGS) (at last
evaluation)

no,Unknown,yes

yes

yes

BCR / ABL

Negative,Not Done,Positive

BCR / ABL

Negative,Not Done,Positive

yes

yes

TEL-AML / AML1

Negative,Not Done,Positive

TEL-AML / AML1

Negative,Not Done,Positive

yes

yes

Other molecular marker

Negative,Not Done,Positive

Other molecular marker

Negative,Not Done,Positive

yes

yes

Specify other molecular marker:

open text

yes

no

Specify other molecular marker:
open text
Did the recipient have central
nervous system leukemia at any time
prior to the start of the preparative
regimen / infusion?
no,Unknown,yes

Rationale for Information Collection Update

yes

no

yes

no

Did the recipient have central nervous
system leukemia at any time prior to the
start of the preparative regimen / infusion? no,Unknown,yes
1st complete remission (include CRi),1st
relapse,2nd complete remission,2nd
relapse, ≥ 3rd complete remission, ≥3rd
relapse,No treatment,Primary induction
What was the disease status?
failure
How many cycles of induction therapy
were required to achieve 1st complete
remission?
1,2, ≥ 3

yes

no

Was the recipient in remission by flow
cytometry?

yes

no

Addition of Information Requested

Was the recipient in remission by
flow cytometry?
Specify method(s) that was used to
assess measurable residual disease
status (check all that apply)

yes

no

Addition of Information Requested

Was measurable residual disease
detected by FISH?

no,yes

Be consistent with current clinical landscape, improve
transplant outcome data

yes

no

Addition of Information Requested

Was measurable residual disease
detected by karyotyping assay?

no,yes

Be consistent with current clinical landscape, improve
transplant outcome data

yes

no

Addition of Information Requested

yes

no

yes

Not applicable,No,Unknown,Yes

1st complete remission (include CRi),1st
relapse,2nd complete remission,2nd relapse, ≥ 3rd
complete remission, ≥3rd relapse,No
treatment,Primary induction failure

What was the disease status?
How many cycles of induction
therapy were required to achieve 1st
complete remission?
1,2, ≥ 3

Deletion of Information Requested

Not applicable,No,Unknown,Yes

Reduce redundancy in data capture

FISH, Karyotyping, Flow Cytometry, PCR, NGS, Not Be consistent with current clinical landscape, improve
assessed
transplant outcome data

Be consistent with current clinical landscape, improve
transplant outcome data

Addition of Information Requested

Which leukemia phenotype was used original leukemia immunophenotype, aberrant
for detection (check all the apply)
phenotype
What is the lower limit of detection
(for the original leukemia
immunophenotype)
open text

no

Addition of Information Requested

What is the lower limit of detection
(for the aberrant phenotype)

open text

Be consistent with current clinical landscape, improve
transplant outcome data

yes

no

Addition of Information Requested

Was measurable residual disease
detected by flow cytometry?

no,yes

Be consistent with current clinical landscape, improve
transplant outcome data

yes

no

Addition of Information Requested

Was measurable residual disease
detected by PCR?

no,yes

Be consistent with current clinical landscape, improve
transplant outcome data

yes

no

Addition of Information Requested

Was measurable residual disease
detected by NGS?

no,yes

Be consistent with current clinical landscape, improve
transplant outcome data

yes

no

Date of most recent relapse:

YYYY/MM/DD

Date of most recent relapse:

YYYY/MM/DD

yes

no

Date assessed:

YYYY/MM/DD

Date assessed:

YYYY/MM/DD

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Be consistent with current clinical landscape, improve
transplant outcome data

Page 24 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Disease
Classification

Disease
Classification

Acute Leukemias
of Ambiguous
Lineage and Other
Myeloid
Neoplasms
yes
Acute Leukemias
of Ambiguous
Lineage and Other
Myeloid
Neoplasms
yes

Disease
Classification

Acute Leukemias
of Ambiguous
Lineage and Other
Myeloid
Neoplasms
Acute Leukemias
of Ambiguous
Lineage and Other
Myeloid
Neoplasms
Chronic
Myelogenous
Leukemia (CML)
Chronic
Myelogenous
Leukemia (CML)
Chronic
Myelogenous
Leukemia (CML)
Chronic
Myelogenous
Leukemia (CML)
Chronic
Myelogenous
Leukemia (CML)
Chronic
Myelogenous
Leukemia (CML)
Chronic
Myelogenous
Leukemia (CML)

Disease
Classification

Chronic
Myelogenous
Leukemia (CML)

Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Disease
Classification

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Chronic
Myelogenous
Leukemia (CML)

no

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Specify acute leukemias of ambiguous
lineage and other myeloid neoplasm
classification

Acute undifferentiated leukemia,Blastic
plasmacytoid dendritic cell neoplasm
,Mixed phenotype acute leukemia,
B/myeloid, NOS,Mixed phenotype acute
leukemia (MPAL) with
t(9;22)(q34.1;q11.2); BCR-ABL1,Mixed
phenotype acute leukemia with t(v;
11q23.3); KMT2A rearranged,Mixed
phenotype acute leukemia, T/myeloid,
NOS,Other acute leukemia of ambiguous
lineage or myeloid neoplasm

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Specify acute leukemias of
ambiguous lineage and other
myeloid neoplasm classification

Acute undifferentiated leukemia,Blastic
plasmacytoid dendritic cell neoplasm ,Mixed
phenotype acute leukemia, B/myeloid, NOS,Mixed
phenotype acute leukemia (MPAL) with
t(9;22)(q34.1;q11.2); BCR-ABL1,Mixed phenotype
acute leukemia with t(v; 11q23.3); KMT2A
rearranged,Mixed phenotype acute leukemia,
T/myeloid, NOS,Other acute leukemia of
ambiguous lineage or myeloid neoplasm

Specify other acute leukemia of
ambiguous lineage or myeloid
neoplasm:

open text

yes

no

Specify other acute leukemia of ambiguous
lineage or myeloid neoplasm:
open text
1st complete remission (no previous
marrow or extramedullary relapse),1st
relapse,2nd complete remission,2nd
relapse, ≥ 3rd complete remission, ≥ 3rd
What was the disease status? (based on
relapse,No treatment,Primary induction
hematological test results)
failure

yes

no

Date assessed:

YYYY/MM/DD

Date assessed:

yes

no

Was therapy given prior to this HCT?

no,yes

Was therapy given prior to this HCT? no,yes

yes

no

Combination chemotherapy

no,yes

Combination chemotherapy

no,yes

yes

no

Hydroxyurea (Droxia, Hydrea)

no,yes

no,yes

yes

no

Tyrosine kinase inhibitor (e.g.imatinib
mesylate, dasatinib, nilotinib)

no,yes

Hydroxyurea (Droxia, Hydrea)
Tyrosine kinase inhibitor
(e.g.imatinib mesylate, dasatinib,
nilotinib)

yes

no

Interferon-α (Intron, Roferon)
(includes PEG)

no,yes

Interferon-α (Intron, Roferon)
(includes PEG)
no,yes

yes

no

Other therapy

no,yes

Other therapy

no,yes

yes

no

Specify other therapy:

Specify other therapy:

open text

What was the disease status?

open text
Accelerated phase,Blast phase,Complete
hematologic response (CHR) preceded
by accelerated phase and/or blast
phase,Complete hematologic response
(CHR) preceded only by chronic
phase,Chronic phase

What was the disease status?

Accelerated phase,Blast phase,Complete
hematologic response (CHR) preceded by
accelerated phase and/or blast phase,Complete
hematologic response (CHR) preceded only by
chronic phase,Chronic phase

Specify level of response

Complete cytogenetic response
(CCyR),Complete molecular remission
(CMR),Minimal cytogenetic
response,Minor cytogenetic
response,Major molecular remission
(MMR),No cytogenetic response (No
CyR),Partial cytogenetic response (PCyR)

Specify level of response

Complete cytogenetic response (CCyR),Complete
molecular remission (CMR),Minimal cytogenetic
response,Minor cytogenetic response,Major
molecular remission (MMR),No cytogenetic
response (No CyR),Partial cytogenetic response
(PCyR)

yes

yes

no

no

no

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Rationale for Information Collection Update

1st complete remission (no previous marrow or
extramedullary relapse),1st relapse,2nd complete
remission,2nd relapse, ≥ 3rd complete remission, ≥
What was the disease status? (based 3rd relapse,No treatment,Primary induction
on hematological test results)
failure

YYYY/MM/DD

no,yes

Page 25 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification

Chronic
Myelogenous
Leukemia (CML)
Chronic
Myelogenous
Leukemia (CML)

Disease
Classification

Myelodysplastic
Syndrome (MDS)

Disease
Classification

Myelodysplastic
Syndrome (MDS)

Disease
Classification
Disease
Classification
Disease
Classification

Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)

Disease
Classification
Disease
Classification
Disease
Classification

Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

yes

no

Number

1st,2nd,3rd or higher

Number

1st,2nd,3rd or higher

yes

no

Date assessed:

YYYY/MM/DD

Date assessed:

YYYY/MM/DD

yes

no

Atypical chronic myeloid leukemia
(aCML), BCR-ABL1-,Chronic
myelomonocytic leukemia
(CMMoL),Juvenile myelomonocytic
leukemia (JMML/JCML),Myelodysplastic
syndrome with isolated
del(5q),Myelodysplastic syndrome with
multilineage dysplasia (MDS-MLD),MDS
/ MPN with ring sideroblasts and
thrombocytosis (MDS / MPN-RST),Myelodysplastic syndrome /
myeloproliferative neoplasm,
unclassifiable, syndrome with single
lineage dysplasia (MDSSLD),Myelodysplastic syndrome (MDS),
unclassifiable,Refractory cytopenia of
childhood. Myelodysplatic Syndrome
with excess blasts (MDS-EB): MDS with
excess blasts-1 (MDS-EB-1),MDS with
excess blasts-2 (MDS-EB-2).
Myelodysplatic Syndrome with ring
What was the MDS subtype at diagnosis? - sideroblasts: MDS-RS with multilineage
If transformed to AML, indicate AML as
dysplasia (MDS-RS-MLD),MDS-RS with
primary disease; also complete AML
single lineage dysplasia (MDS-RSDisease Classification questions
SLD),Myelodysplastic
MDS-U with 1% blood blasts,MDS-U
based on defining cytogenetic
Specify Myelodysplastic syndrome,
abnormality,MDS-U with single lineage
unclassifiable (MDS-U)
dysplasia and pancytopenia

yes

no

Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)

yes

no

yes

no

yes

no

Was the disease MDS therapy related?
Did the recipient have a predisposing
condition?

No,Yes
no,Unknown,yes
no,Unknown,yes

Atypical chronic myeloid leukemia (aCML), BCRABL1-,Chronic myelomonocytic leukemia
(CMMoL),Juvenile myelomonocytic leukemia
(JMML/JCML),Myelodysplastic syndrome with
isolated del(5q),Myelodysplastic syndrome with
multilineage dysplasia (MDS-MLD),MDS / MPN
with ring sideroblasts and thrombocytosis (MDS /
MPN-RS-T),Myelodysplastic syndrome /
myeloproliferative neoplasm, unclassifiable,
syndrome with single lineage dysplasia (MDSSLD),Myelodysplastic syndrome (MDS),
unclassifiable,Refractory cytopenia of childhood.
Myelodysplatic Syndrome with excess blasts
(MDS-EB): MDS with excess blasts-1 (MDS-EBWhat was the MDS subtype at
1),MDS with excess blasts-2 (MDS-EB-2).
diagnosis? - If transformed to AML, Myelodysplatic Syndrome with ring sideroblasts:
indicate AML as primary disease; also MDS-RS with multilineage dysplasia (MDS-RScomplete AML Disease Classification MLD),MDS-RS with single lineage dysplasia (MDSquestions
RS-SLD),Myelodysplastic

Specify Myelodysplastic syndrome,
unclassifiable (MDS-U)
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)
Was the disease MDS therapy
related?
Did the recipient have a predisposing
condition?

MDS-U with 1% blood blasts,MDS-U based on
defining cytogenetic abnormality,MDS-U with
single lineage dysplasia and pancytopenia

No,Yes
no,Unknown,yes
no,Unknown,yes

yes

no

Specify condition

Aplastic anemia,DDX41-associated
familial MDS,Fanconi anemia,GATA2
deficiency (including Emberger
syndrome, MonoMac syndrome, DCML
deficiency) ,Li-Fraumeni Syndrome,Other
condition,Paroxysmal nocturnal
hemoglobinuria,Diamond-Blackfan
Anemia,RUNX1 deficiency (previously
“familial platelet disorder with
propensity to myeloid malignancies”)
,SAMD9- or SAMD9L-associated familial
MDS,Shwachman-Diamond
Syndrome,Telomere biology disorder
(including dyskeratosis congenita)

yes

no

Specify other condition:

open text

Specify other condition:

open text

yes

yes

Date CBC drawn:

YYYY/MM/DD

Date CBC drawn:

YYYY/MM/DD

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Rationale for Information Collection Update

Specify condition

Aplastic anemia,DDX41-associated familial
MDS,Fanconi anemia,GATA2 deficiency (including
Emberger syndrome, MonoMac syndrome, DCML
deficiency) ,Li-Fraumeni Syndrome,Other
condition,Paroxysmal nocturnal
hemoglobinuria,Diamond-Blackfan Anemia,RUNX1
deficiency (previously “familial platelet disorder
with propensity to myeloid malignancies”)
,SAMD9- or SAMD9L-associated familial
MDS,Shwachman-Diamond Syndrome,Telomere
biology disorder (including dyskeratosis congenita)

Page 26 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Disease
Classification

yes

Myelodysplastic
Syndrome (MDS)

yes

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

WBC

Known,Unknown

WBC

Known,Unknown

WBC

___ ___ ___ ___ ___ ___ ● ___ x 109/L (x
103/mm3)
___ ___ ___ ___ ___ ___ ● ___ x 106/L

9

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)

Disease
Classification
Disease
Classification

Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)

Disease
Classification
Disease
Classification

Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)

Disease
Classification
Disease
Classification
Disease
Classification

Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)

Disease
Classification

Myelodysplastic
Syndrome (MDS)

Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)

yes

yes

WBC

___ ___ ___ ___ ___ ___ ● ___ x 10 /L (x
103/mm3)
___ ___ ___ ___ ___ ___ ● ___ x 106/L

yes

yes

Neutrophils

Known,Unknown

Neutrophils

Known,Unknown

yes

yes

Neutrophils

___ ___%

Neutrophils

___ ___%

yes

yes

Blasts in blood

Known,Unknown

Blasts in blood

Known,Unknown

yes

yes

Blasts in blood

___ ___%

Blasts in blood

___ ___%

yes

yes

Hemoglobin

Known,Unknown
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___

Hemoglobin

Known,Unknown
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___

yes

yes

yes

yes

yes

yes

yes

yes

yes

At Diagnosis: Hemoglobin
Were RBCs transfused ≤ 30 days before
date of test?

g/dL
g/L
mmol/L

No,Yes
Known,Unknown

yes

Platelets
Were platelets transfused ≤ 7 days before
date of test?
Were platelets transfused ≤ 7 days before
date of test?

yes

yes

Blasts in bone marrow

yes

yes

yes

yes

Blasts in bone marrow
Were cytogenetics tested (karyotyping or
FISH)?

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Specify number of distinct cytogenetic
abnormalities

yes

yes

open text
Four or more (4 or more),One (1),Three
(3),Two (2)
del(11q) / 11q-,del(12p) / 12p-,del(20q) /
20q-,del(3q) / 3q-,del(5q) / 5q-,del(7q) /
7q-,del(9q) / 9q-,del(13q) / 13q,i17q,inv(3),-13,-20,-5,-7,-Y,Other
abnormality,t(1;3),t(11;16),t(2;11),t(3;21
Specify abnormalities (check all that apply) ),t(3;3),t(6;9),+19,+8

yes

yes

Specify other abnormality:

open text

yes

yes

Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)

No,Yes

yes

yes

yes

yes

At Diagnosis: Hemoglobin
Were RBCs transfused ≤ 30 days
before date of test?

Known,Unknown

No,Yes
Known,Unknown

Blasts in bone marrow

Known,Unknown

__ ___ ___%

g/dL
g/L
mmol/L

No,Yes

Platelets
Were platelets transfused ≤ 7 days
before date of test?
Were platelets transfused ≤ 7 days
before date of test?

No,Yes

No,Yes
No,Yes

__ ___ ___%

no,Unknown,yes

Blasts in bone marrow
Were cytogenetics tested
(karyotyping or FISH)?

Were cytogenetics tested via FISH?

No,Yes

Were cytogenetics tested via FISH?

No,Yes

Sample source

Peripheral blood,Bone marrow
Abnormalities identified,No
abnormalities

Sample source

Peripheral blood,Bone marrow

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Specify number of distinct
cytogenetic abnormalities

Abnormalities identified,No abnormalities

open text

Were cytogenetics tested via karyotyping? No,Yes

Specify other abnormality:
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)
Were cytogenetics tested via
karyotyping?

yes

Sample source

Peripheral blood,Bone marrow

Sample source

Peripheral blood,Bone marrow

yes

Results of tests

Abnormalities identified,No
abnormalities,No evaluable metaphases

Results of tests

Abnormalities identified,No abnormalities,No
evaluable metaphases

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Rationale for Information Collection Update

no,Unknown,yes

open text

Four or more (4 or more),One (1),Three (3),Two (2)
del(11q) / 11q-,del(12p) / 12p-,del(20q) / 20q,del(3q) / 3q-,del(5q) / 5q-,del(7q) / 7q-,del(9q) /
9q-,del(13q) / 13q-,i17q,inv(3),-13,-20,-5,-7,Y,Other
Specify abnormalities (check all that abnormality,t(1;3),t(11;16),t(2;11),t(3;21),t(3;3),t(
apply)
6;9),+19,+8

No,Yes
No,Yes

Page 27 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification

Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)

Disease
Classification
Disease
Classification

Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)

Disease
Classification

Myelodysplastic
Syndrome (MDS)

Disease
Classification

Myelodysplastic
Syndrome (MDS)

Disease
Classification

Myelodysplastic
Syndrome (MDS)

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Specify number of distinct cytogenetic
abnormalities

yes

yes

yes

yes

yes

yes

open text
Four or more (4 or more),One (1),Three
(3),Two (2)
del(11q) / 11q-,del(12p) / 12p-,del(20q) /
20q-,del(3q) / 3q-,del(5q) / 5q-,del(7q) /
7q-,del(9q) / 9q-,del(13q) / 13q,i17q,inv(3),-13,-20,-5,-7,-Y,Other
abnormality,t(1;3),t(11;16),t(2;11),t(3;21
Specify abnormalities (check all that apply) ),t(3;3),t(6;9),+19,+8

yes

yes

Specify other abnormality:

open text

yes

yes

Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)

No,Yes

yes

Did the recipient progress or transform to
a different MDS subtype or AML between
diagnosis and the start of the preparative
regimen/ infusion?

No,Yes

yes

yes

yes

Specify the MDS subtype or AML after
transformation

yes

yes

yes

yes

Specify Myelodysplastic syndrome,
unclassifiable (MDS-U)
Specify the date of the most recent
transformation:

yes

yes

yes

yes

yes

Transformed to AML,Chronic
myelomonocytic leukemia
(CMMoL),Myelodysplastic syndrome
with isolated del(5q),Myelodysplastic
syndrome with multilineage dysplasia
(MDS-MLD),MDS / MPN with ring
sideroblasts and thrombocytosis (MDS /
MPN-RS-T),Myelodysplastic syndrome /
myeloproliferative neoplasm,
unclassifiable,Myelodysplastic syndrome
with single lineage dysplasia (MDSSLD),Myelodysplastic syndrome (MDS),
unclassifiable,Refractory cytopenia of
childhood. Myelodysplatic Syndrome
with excess blasts (MDS-EB): MDS with
excess blasts-1 (MDS-EB-1),MDS with
excess blasts-2 (MDS-EB-2).
Myelodysplatic syndrome with ring
sideroblasts: MDS-RS with multilineage
dysplasia (MDS-RS-MLD),MDS-RS with
single lineage dysplasia (MDS-RS-SLD).
MDS-U with 1% blood blasts,MDS-U
based on defining cytogenetic
abnormality,MDS-U with single lineage
dysplasia and pancytopenia

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Specify number of distinct
cytogenetic abnormalities

open text

Four or more (4 or more),One (1),Three (3),Two (2)
del(11q) / 11q-,del(12p) / 12p-,del(20q) / 20q,del(3q) / 3q-,del(5q) / 5q-,del(7q) / 7q-,del(9q) /
9q-,del(13q) / 13q-,i17q,inv(3),-13,-20,-5,-7,Y,Other
Specify abnormalities (check all that abnormality,t(1;3),t(11;16),t(2;11),t(3;21),t(3;3),t(
apply)
6;9),+19,+8
Specify other abnormality:
open text
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)
No,Yes
Did the recipient progress or
transform to a different MDS subtype
or AML between diagnosis and the
start of the preparative regimen/
infusion?
No,Yes

Specify the MDS subtype or AML
after transformation

Transformed to AML,Chronic myelomonocytic
leukemia (CMMoL),Myelodysplastic syndrome
with isolated del(5q),Myelodysplastic syndrome
with multilineage dysplasia (MDS-MLD),MDS /
MPN with ring sideroblasts and thrombocytosis
(MDS / MPN-RS-T),Myelodysplastic syndrome /
myeloproliferative neoplasm,
unclassifiable,Myelodysplastic syndrome with
single lineage dysplasia (MDSSLD),Myelodysplastic syndrome (MDS),
unclassifiable,Refractory cytopenia of childhood.
Myelodysplatic Syndrome with excess blasts
(MDS-EB): MDS with excess blasts-1 (MDS-EB1),MDS with excess blasts-2 (MDS-EB-2).
Myelodysplatic syndrome with ring sideroblasts:
MDS-RS with multilineage dysplasia (MDS-RSMLD),MDS-RS with single lineage dysplasia (MDSRS-SLD).
MDS-U with 1% blood blasts,MDS-U based on
defining cytogenetic abnormality,MDS-U with
single lineage dysplasia and pancytopenia

YYYY/MM/DD

Specify Myelodysplastic syndrome,
unclassifiable (MDS-U)
Specify the date of the most recent
transformation:

Date of MDS diagnosis:

YYYY/MM/DD

Date of MDS diagnosis:

YYYY/MM/DD

Date CBC drawn:

YYYY/MM/DD

Date CBC drawn:

YYYY/MM/DD

yes

WBC

Known,Unknown

WBC

Known,Unknown

yes

yes

Neutrophils

Known,Unknown

Neutrophils

Known,Unknown

yes

yes

Neutrophils

___ ___%

Neutrophils

___ ___%

yes

yes

Blasts in blood

Known,Unknown

Blasts in blood

Known,Unknown

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Rationale for Information Collection Update

YYYY/MM/DD

Page 28 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification

Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)

Disease
Classification
Disease
Classification
Disease
Classification

Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

yes

yes

Blasts in blood

___ ___%

Blasts in blood

___ ___%

yes

yes

Hemoglobin

Known,Unknown
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___

Hemoglobin

Known,Unknown
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___

yes

yes

yes

yes

Prior to Infusion: Hemoglobin
Were RBCs transfused ≤ 30 days before
date of test?

yes

yes

Platelets

g/dL
g/L
mmol/L

No,Yes
Known,Unknown

Prior to Infusion: Hemoglobin
Were RBCs transfused ≤ 30 days
before date of test?

Rationale for Information Collection Update

g/dL
g/L
mmol/L

No,Yes

Platelets

Known,Unknown

Platelets

___ ___ ___ ___ ___ ___ ___ x 10 /L (x
103/mm3)
___ ___ ___ ___ ___ ___ ___ ___ x 106/L

Platelets

___ ___ ___ ___ ___ ___ ___ x 109/L (x 103/mm3)
___ ___ ___ ___ ___ ___ ___ ___ x 106/L

Platelets

___ ___ ___ ___ ___ ___ ___ x 109/L (x 103/mm3)
___ ___ ___ ___ ___ ___ ___ ___ x 106/L

Blasts in bone marrow

Known,Unknown

9

Disease
Classification

Myelodysplastic
Syndrome (MDS)

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)

Disease
Classification
Disease
Classification

Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)

Disease
Classification
Disease
Classification

Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)

Disease
Classification
Disease
Classification
Disease
Classification

Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)

Disease
Classification

Myelodysplastic
Syndrome (MDS)

Disease
Classification
Disease
Classification

Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)

yes

yes

yes

yes

Platelets

___ ___ ___ ___ ___ ___ ___ x 109/L (x
103/mm3)
___ ___ ___ ___ ___ ___ ___ ___ x 106/L

yes

yes

Blasts in bone marrow

Known,Unknown

yes

yes

yes

yes

Blasts in bone marrow
Were cytogenetics tested (karyotyping or
FISH)?

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Specify number of distinct cytogenetic
abnormalities

yes

yes

open text
Four or more (4 or more),One (1),Three
(3),Two (2)
del(11q) / 11q-,del(12p) / 12p-,del(20q) /
20q-,del(3q) / 3q-,del(5q) / 5q-,del(7q) /
7q-,del(9q) / 9q-,del(13q) / 13q,i17q,inv(3),-13,-20,-5,-7,-Y,Other
abnormality,t(1;3),t(11;16),t(2;11),t(3;21
Specify abnormalities (check all that apply) ),t(3;3),t(6;9),+19,+8

yes

yes

Specify other abnormality:

open text

yes

yes

Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)

No,Yes

yes

yes

yes

__ ___ ___%

__ ___ ___%

no,Unknown,yes

Blasts in bone marrow
Were cytogenetics tested
(karyotyping or FISH)?

Were cytogenetics tested via FISH?

No,Yes

Were cytogenetics tested via FISH?

No,Yes

Sample source

Peripheral blood,Bone marrow
Abnormalities identified,No
abnormalities

Sample source

Peripheral blood,Bone marrow

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Specify number of distinct
cytogenetic abnormalities

Abnormalities identified,No abnormalities

open text

Were cytogenetics tested via karyotyping? No,Yes

Specify other abnormality:
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)
Were cytogenetics tested via
karyotyping?

yes

Sample source

Sample source

Peripheral blood,Bone marrow

yes

yes

yes

yes

yes

yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Specify number of distinct cytogenetic
abnormalities

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Peripheral blood,Bone marrow
Abnormalities identified,No
abnormalities,No evaluable metaphases

open text
Four or more (4 or more),One (1),Three
(3),Two (2)

no,Unknown,yes

open text

Four or more (4 or more),One (1),Three (3),Two (2)
del(11q) / 11q-,del(12p) / 12p-,del(20q) / 20q,del(3q) / 3q-,del(5q) / 5q-,del(7q) / 7q-,del(9q) /
9q-,del(13q) / 13q-,i17q,inv(3),-13,-20,-5,-7,Y,Other
Specify abnormalities (check all that abnormality,t(1;3),t(11;16),t(2;11),t(3;21),t(3;3),t(
apply)
6;9),+19,+8

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:
Specify number of distinct
cytogenetic abnormalities

No,Yes
No,Yes

Abnormalities identified,No abnormalities,No
evaluable metaphases

open text
Four or more (4 or more),One (1),Three (3),Two (2)

Page 29 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Disease
Classification
Disease
Classification

Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)

Disease
Classification

Myelodysplastic
Syndrome (MDS)

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Disease
Classification

Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)
Myelodysplastic
Syndrome (MDS)

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

yes

yes

del(11q) / 11q-,del(12p) / 12p-,del(20q) /
20q-,del(3q) / 3q-,del(5q) / 5q-,del(7q) /
7q-,del(9q) / 9q-,del(13q) / 13q,i17q,inv(3),-13,-20,-5,-7,-Y,Other
abnormality,t(1;3),t(11;16),t(2;11),t(3;21
Specify abnormalities (check all that apply) ),t(3;3),t(6;9),+19,+8

del(11q) / 11q-,del(12p) / 12p-,del(20q) / 20q,del(3q) / 3q-,del(5q) / 5q-,del(7q) / 7q-,del(9q) /
9q-,del(13q) / 13q-,i17q,inv(3),-13,-20,-5,-7,Y,Other
Specify abnormalities (check all that abnormality,t(1;3),t(11;16),t(2;11),t(3;21),t(3;3),t(
apply)
6;9),+19,+8

yes

yes

Specify other abnormality:

open text

yes

yes

Was documentation submitted to the
CIBMTR? (e.g. cytogenetic or FISH report)

No,Yes

Specify other abnormality:
Was documentation submitted to
the CIBMTR? (e.g. cytogenetic or
FISH report)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Complete remission (CR),Hematologic
improvement (HI),Not assessed,No
response (NR) / stable disease
(SD),Progression from hematologic
improvement (Prog from HI),Relapse
from complete remission (Rel from CR)

yes

no

yes

no

yes

no

What was the disease status?
Specify the cell line examined to determine
HI status
HI-E,HI-N,HI-P
Low-transfusion burden (LTB),NonSpecify transfusion dependence
transfused (NTD)

yes

no

Date assessed:

Myeloproliferative
Neoplasms (MPN) yes

no

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

no

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

no

What was the MPN subtype at diagnosis?

Specify systemic mastocytosis
Was documentation submitted to the
CIBMTR? (e.g. pathology report used for
diagnosis)

YYYY/MM/DD
Chronic eosinophilic leukemia, not
otherwise specified (NOS),Primary
myelofibrosis (PMF),Chronic neutrophilic
leukemia,,Essential
thrombocythemia,Myeloproliferative
neoplasm (MPN), unclassifiable,Myeloid
/ lymphoid neoplasms with FGFR1
rearrangement,Myeloid / lymphoid
neoplasms with PCM1-JAK2,Myeloid /
lymphoid neoplasms with PDGFRA
rearrangement,Myeloid / lymphoid
neoplasms with PDGFRB
rearrangement,Polycythemia vera
(PCV),Mastocytosis: Cutaneous
mastocytosis (CM), Systemic
mastocytosis, Mast cell sarcoma (MCS)
Aggressive systemic mastocytosis
(ASM),Indolent systemic mastocytosis
(ISM),Mast cell leukemia (MCL),Systemic
mastocytosis with an associated
hematological neoplasm (SMAHN),Smoldering systemic mastocytosis
(SSM)

No,Yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Did the recipient have constitutional
symptoms in six months before diagnosis?
(symptoms are >10% weight loss in 6
months, night sweats, or unexplained fever
higher than 37.5 °C)
No,Unknown,Yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Date CBC drawn:

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

YYYY/MM/DD

Change/Clarification of Information Requested

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

What was the disease status?
Specify the cell lines examined to
determine HI status

open text

No,Yes

Complete remission (CR),Hematologic
improvement (HI),Not assessed,No response (NR) /
stable disease (SD),Progression from hematologic
improvement (Prog from HI),Relapse from
complete remission (Rel from CR)

Specify transfusion dependence

HI-E,HI-N,HI-P
Low-transfusion burden (LTB),Non-transfused
(NTD)

Date assessed:

YYYY/MM/DD

What was the MPN subtype at
diagnosis?

Chronic eosinophilic leukemia, not otherwise
specified (NOS),Primary myelofibrosis
(PMF),Chronic neutrophilic leukemia,,Essential
thrombocythemia,Myeloproliferative neoplasm
(MPN), unclassifiable,Myeloid / lymphoid
neoplasms with FGFR1 rearrangement,Myeloid /
lymphoid neoplasms with PCM1-JAK2,Myeloid /
lymphoid neoplasms with PDGFRA
rearrangement,Myeloid / lymphoid neoplasms
with PDGFRB rearrangement,Polycythemia vera
(PCV),Mastocytosis: Cutaneous mastocytosis
(CM), Systemic mastocytosis, Mast cell sarcoma
(MCS)

Specify systemic mastocytosis
Was documentation submitted to
the CIBMTR? (e.g. pathology report
used for diagnosis)

Rationale for Information Collection Update

Examples added or typographical errors corrected for
clarification

Aggressive systemic mastocytosis (ASM),Indolent
systemic mastocytosis (ISM),Mast cell leukemia
(MCL),Systemic mastocytosis with an associated
hematological neoplasm (SM-AHN),Smoldering
systemic mastocytosis (SSM)

No,Yes

Did the recipient have constitutional
symptoms in six months before
diagnosis? (symptoms are >10%
weight loss in 6 months, night
sweats, or unexplained fever higher
than 37.5 °C)
No,Unknown,Yes

Date CBC drawn:

YYYY/MM/DD

Page 30 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Myeloproliferative
Neoplasms (MPN) yes

yes

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

WBC

Known,Unknown

WBC

Known,Unknown

WBC

___ ___ ___ ___ ___ ___ ● ___ x 109/L (x
103/mm3)
___ ___ ___ ___ ___ ___ ● ___ x 106/L

9

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

WBC

___ ___ ___ ___ ___ ___ ● ___ x 10 /L (x
103/mm3)
___ ___ ___ ___ ___ ___ ● ___ x 106/L

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Neutrophils

Known,Unknown

Neutrophils

Known,Unknown

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Neutrophils

___ ___%

Neutrophils

___ ___%

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Blasts in blood

Known,Unknown

Blasts in blood

Known,Unknown

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Blasts in blood

___ ___%

Blasts in blood

___ ___%

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Hemoglobin

Myeloproliferative
Neoplasms (MPN) yes

yes

Hemoglobin

Known,Unknown
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___

Hemoglobin

Disease
Classification

Hemoglobin

Known,Unknown
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Were RBCs transfused ≤ 30 days before
date of test?

No,Yes

Were RBCs transfused ≤ 30 days
before date of test?

No,Yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Platelets

Known,Unknown

Platelets

Known,Unknown

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Platelets

___ ___ ___ ___ ___ ___ ___ x 109/L (x
103/mm3)
___ ___ ___ ___ ___ ___ ___ ___ x 106/L

Platelets

___ ___ ___ ___ ___ ___ ___ x 109/L (x 103/mm3)
___ ___ ___ ___ ___ ___ ___ ___ x 106/L

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Were platelets transfused ≤ 7 days before
date of test?

No,Yes

Were platelets transfused ≤ 7 days
before date of test?

No,Yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Blasts in bone marrow

Known,Unknown

Blasts in bone marrow

Known,Unknown

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Blasts in bone marrow

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Were tests for driver mutations
performed?

No,Unknown,Yes

Were tests for driver mutations
performed?

No,Unknown,Yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

JAK2

Negative,Not done,Positive

JAK2

Negative,Not done,Positive

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

JAK2 V617F

Negative,Not done,Positive

JAK2 V617F

Negative,Not done,Positive

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

JAK2 Exon 12

Negative,Not done,Positive

JAK2 Exon 12

Negative,Not done,Positive

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

CALR

Negative,Not done,Positive

CALR

Negative,Not done,Positive

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

CALR type 1

Negative,Not done,Positive

CALR type 1

Negative,Not done,Positive

g/dL
g/L
mmol/L

__ ___ ___%

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Rationale for Information Collection Update

g/dL
g/L
mmol/L

__ ___ ___%
Blasts in bone marrow

Page 31 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

CALR type 2

Negative,Not done,Positive

CALR type 2

Negative,Not done,Positive

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Not defined

Negative,Not done,Positive

Not defined

Negative,Not done,Positive

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

MPL

Negative,Not done,Positive

MPL

Negative,Not done,Positive

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

CSF3R

Negative,Not done,Positive

CSF3R

Negative,Not done,Positive

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Was documentation submitted to the
CIBMTR?

No,Yes

Was documentation submitted to
the CIBMTR?

No,Yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Were cytogenetics tested (karyotyping or
FISH)?

no,Unknown,yes

Were cytogenetics tested
(karyotyping or FISH)?

no,Unknown,yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Were cytogenetics tested via FISH?

No,Yes

Were cytogenetics tested via FISH?

No,Yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Sample source

Peripheral blood,Bone marrow

Sample source

Peripheral blood,Bone marrow

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Myeloproliferative
Neoplasms (MPN) yes

yes

open text

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

Abnormalities identified,No abnormalities

Disease
Classification

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Specify number of distinct cytogenetic
abnormalities

Four or more (4 or more),One (1),Three
(3),Two (2)

Specify number of distinct
cytogenetic abnormalities

del(11q) / 11q-,del(12p) / 12p-,del(20q) / 20q,del(5q) / 5q-,del(7q) / 7q-,del(13q) / 13q,dup(1),i17q,inv(3),-5,-7,-Y,Other
Specify abnormalities (check all that abnormality,t(1;any),t(11q23;any),t(12p11.2;any),
apply)
t(3q21;any),t(6;9),+8,+9

Abnormalities identified,No
abnormalities

open text

Four or more (4 or more),One (1),Three (3),Two (2)

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

del(11q) / 11q-,del(12p) / 12p-,del(20q) /
20q-,del(5q) / 5q-,del(7q) / 7q-,del(13q)
/ 13q-,dup(1),i17q,inv(3),-5,-7,-Y,Other
abnormality,t(1;any),t(11q23;any),t(12p
Specify abnormalities (check all that apply) 11.2;any),t(3q21;any),t(6;9),+8,+9

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Specify other abnormality:

open text

Specify other abnormality:

open text

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Was documentation submitted to the
CIBMTR? (e.g. FISH report)

No,Yes

Was documentation submitted to
the CIBMTR? (e.g. FISH report)

No,Yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Were cytogenetics tested via karyotyping? No,Yes

Were cytogenetics tested via
karyotyping?

No,Yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Sample source

Sample source

Peripheral blood,Bone marrow

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Specify number of distinct cytogenetic
abnormalities

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Peripheral blood,Bone marrow
Abnormalities identified,No
abnormalities,No evaluable metaphases

open text

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

Four or more (4 or more),One (1),Three
(3),Two (2)

Specify number of distinct
cytogenetic abnormalities

Rationale for Information Collection Update

Abnormalities identified,No abnormalities,No
evaluable metaphases

open text

Four or more (4 or more),One (1),Three (3),Two (2)

Page 32 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

del(11q) / 11q-,del(12p) / 12p-,del(20q) /
20q-,del(5q) / 5q-,del(7q) / 7q-,del(13q)
/ 13q-,dup(1),i17q,inv(3),-5,-7,-Y,Other
abnormality,t(1;any),t(11q23;any),t(12p
Specify abnormalities (check all that apply) 11.2;any),t(3q21;any),t(6;9),+8,+9

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Specify other abnormality:

open text

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Was documentation submitted to the
CIBMTR? (e.g. karyotyping report)

No,Yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

no

Did the recipient progress or transform to
a different MPN subtype or AML between
diagnosis and the start of the preparative
regimen / infusion?

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

no

Specify the MPN subtype or AML after
transformation

No,Yes
Transformed to AML,Post-essential
thrombocythemic myelofibrosis,Postpolycythemic myelofibrosis

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

no

Specify the date of the most recent
transformation:

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

no

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
del(11q) / 11q-,del(12p) / 12p-,del(20q) / 20q,del(5q) / 5q-,del(7q) / 7q-,del(13q) / 13q,dup(1),i17q,inv(3),-5,-7,-Y,Other
Specify abnormalities (check all that abnormality,t(1;any),t(11q23;any),t(12p11.2;any),
apply)
t(3q21;any),t(6;9),+8,+9

Specify other abnormality:
Was documentation submitted to
the CIBMTR? (e.g. karyotyping
report)
Did the recipient progress or
transform to a different MPN
subtype or AML between diagnosis
and the start of the preparative
regimen / infusion?

open text

No,Yes

Specify the MPN subtype or AML
after transformation

No,Yes
Transformed to AML,Post-essential
thrombocythemic myelofibrosis,Post-polycythemic
myelofibrosis

YYYY/MM/DD

Specify the date of the most recent
transformation:

YYYY/MM/DD

Date of MPN diagnosis:

YYYY/MM/DD

Date of MPN diagnosis:

YYYY/MM/DD

no

Specify transfusion dependence at last
evaluation prior to the start of the
preparative regimen / infusion

High-transfusion burden (HTB)- (≥ 8 RBCs
in 16weeks; ≥ 4 in 8 weeks),Lowtransfusion burden (LTB)-(3-7 RBCs in 16
weeks in at least 2 transfusion episodes;
maximum of 3 in 8 weeks),Nontransfused (NTD) –(0 RBCs in 16 weeks)

yes

Did the recipient have constitutional
symptoms in six months before last
evaluation prior to the start of the
preparative regimen / infusion? (symptoms
are >10% weight loss in 6 months, night
sweats, or unexplained fever higher than
37.5 °C)
No,Unknown,Yes

Specify transfusion dependence at
last evaluation prior to the start of
the preparative regimen / infusion
Did the recipient have constitutional
symptoms in six months before last
evaluation prior to the start of the
preparative regimen / infusion?
(symptoms are >10% weight loss in 6
months, night sweats, or
unexplained fever higher than 37.5
°C)
No,Unknown,Yes

Did the recipient have splenomegaly
at last evaluation prior to the start of
the preparative regimen / infusion? No,Not applicable(splenectomy) ,Unknown,Yes
Specify the method used to measure
spleen size
CT/MRI scan,Physical exam,Ultrasound

High-transfusion burden (HTB)- (≥ 8 RBCs in
16weeks; ≥ 4 in 8 weeks),Low-transfusion burden
(LTB)-(3-7 RBCs in 16 weeks in at least 2
transfusion episodes; maximum of 3 in 8
weeks),Non-transfused (NTD) –(0 RBCs in 16
weeks)

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

no

Did the recipient have splenomegaly at last
evaluation prior to the start of the
No,Not applicable(splenectomy)
preparative regimen / infusion?
,Unknown,Yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

no

Specify the method used to measure
spleen size

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

no

Specify the spleen size:

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

no

Specify the spleen size:

Specify the spleen size:

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

no

Did the recipient have hepatomegaly at
last evaluation prior to the start of the
preparative regimen / infusion?

no,Unknown,yes

Did the recipient have hepatomegaly
at last evaluation prior to the start of
the preparative regimen / infusion? no,Unknown,yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

no

Specify the method used to measure liver
size

CT/MRI scan,Physical exam,Ultrasound

Specify the method used to measure
liver size
CT/MRI scan,Physical exam,Ultrasound

CT/MRI scan,Physical exam,Ultrasound
: ___ ___ centimeters below left costal
margin

: ___ ___ centimeters below left costal margin

Specify the spleen size:

:___ ___ centimeters

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Rationale for Information Collection Update

:___ ___ centimeters

Page 33 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:
: ___ ___ centimeters below right costal
margin

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

no

Specify the liver size:

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

no

Specify the liver size:

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Date CBC drawn:

YYYY/MM/DD

Date CBC drawn:

YYYY/MM/DD

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

WBC

Known,Unknown

WBC

Known,Unknown

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

WBC

___ ___ ___ ___ ___ ___ ● ___ x 109/L (x
103/mm3)
___ ___ ___ ___ ___ ___ ● ___ x 106/L

WBC

___ ___ ___ ___ ___ ___ ● ___ x 109/L (x
103/mm3)
___ ___ ___ ___ ___ ___ ● ___ x 106/L

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Neutrophils

Known,Unknown

Neutrophils

Known,Unknown

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Neutrophils

___ ___%

Neutrophils

___ ___%

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Blasts in blood

Known,Unknown

Blasts in blood

Known,Unknown

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Blasts in blood

___ ___%

Blasts in blood

___ ___%

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Hemoglobin

Hemoglobin

Hemoglobin

Known,Unknown
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___

Were RBCs transfused ≤ 30 days
before date of test?

No,Yes

Platelets

Known,Unknown

Platelets

___ ___ ___ ___ ___ ___ ___ x 109/L (x 103/mm3)
___ ___ ___ ___ ___ ___ ___ ___ x 106/L

Rationale for Information Collection Update

: ___ ___ centimeters below right costal margin

Specify the liver size:

: ___ ___ centimeters

: ___ ___ centimeters

Specify the liver size:

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Hemoglobin

Known,Unknown
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___
___ ___ ___ ___ ● ___ ___

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Were RBCs transfused ≤ 30 days before
date of test?

No,Yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Platelets

Known,Unknown

g/dL
g/L
mmol/L

g/dL
g/L
mmol/L

9

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Platelets

___ ___ ___ ___ ___ ___ ___ x 10 /L (x
103/mm3)
___ ___ ___ ___ ___ ___ ___ ___ x 106/L

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Were platelets transfused ≤ 7 days before
date of test?

No,Yes

Were platelets transfused ≤ 7 days
before date of test?

No,Yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Blasts in bone marrow

Known,Unknown

Blasts in bone marrow

Known,Unknown

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Blasts in bone marrow

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Were tests for driver mutations
performed?

No,Unknown,Yes

Were tests for driver mutations
performed?

No,Unknown,Yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

JAK2

Negative,Not done,Positive

JAK2

Negative,Not done,Positive

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

JAK2 V617F

Negative,Not done,Positive

JAK2 V617F

Negative,Not done,Positive

__ ___ ___%

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

__ ___ ___%
Blasts in bone marrow

Page 34 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

JAK2 Exon 12

Negative,Not done,Positive

JAK2 Exon 12

Negative,Not done,Positive

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

CALR

Negative,Not done,Positive

CALR

Negative,Not done,Positive

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

CALR type 1

Negative,Not done,Positive

CALR type 1

Negative,Not done,Positive

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

CALR type 2

Negative,Not done,Positive

CALR type 2

Negative,Not done,Positive

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Not defined

Negative,Not done,Positive

Not defined

Negative,Not done,Positive

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

MPL

Negative,Not done,Positive

MPL

Negative,Not done,Positive

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

CSF3R

Negative,Not done,Positive

CSF3R

Negative,Not done,Positive

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Was documentation submitted to the
CIBMTR?

No,Yes

Was documentation submitted to
the CIBMTR?

No,Yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Were cytogenetics tested (karyotyping or
FISH)?

no,Unknown,yes

Were cytogenetics tested
(karyotyping or FISH)?

no,Unknown,yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Were cytogenetics tested via FISH?

No,Yes

Were cytogenetics tested via FISH?

No,Yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Sample source

Peripheral blood,Bone marrow

Sample source

Peripheral blood,Bone marrow

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Myeloproliferative
Neoplasms (MPN) yes

yes

open text

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

Abnormalities identified,No abnormalities

Disease
Classification

Results of tests
International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Specify number of distinct cytogenetic
abnormalities

Four or more (4 or more),One (1),Three
(3),Two (2)

Specify number of distinct
cytogenetic abnormalities

del(11q) / 11q-,del(12p) / 12p-,del(20q) / 20q,del(5q) / 5q-,del(7q) / 7q-,del(13q) / 13q,dup(1),i17q,inv(3),-5,-7,-Y,Other
Specify abnormalities (check all that abnormality,t(1;any),t(11q23;any),t(12p11.2;any),
apply)
t(3q21;any),t(6;9),+8,+9

open text

Specify other abnormality:

open text

No,Yes

Was documentation submitted to
the CIBMTR? (e.g. FISH report)

No,Yes

Abnormalities identified,No
abnormalities

open text

Four or more (4 or more),One (1),Three (3),Two (2)

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

del(11q) / 11q-,del(12p) / 12p-,del(20q) /
20q-,del(5q) / 5q-,del(7q) / 7q-,del(13q)
/ 13q-,dup(1),i17q,inv(3),-5,-7,-Y,Other
abnormality,t(1;any),t(11q23;any),t(12p
Specify abnormalities (check all that apply) 11.2;any),t(3q21;any),t(6;9),+8,+9

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Specify other abnormality:

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Was documentation submitted to the
CIBMTR? (e.g. FISH report)

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Were cytogenetics tested via karyotyping? No,Yes

Were cytogenetics tested via
karyotyping?

No,Yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Sample source

Peripheral blood,Bone marrow

Sample source

Peripheral blood,Bone marrow

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Results of tests

Abnormalities identified,No
abnormalities,No evaluable metaphases

Results of tests

Abnormalities identified,No abnormalities,No
evaluable metaphases

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Rationale for Information Collection Update

Page 35 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

open text

International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

open text

Four or more (4 or more),One (1),Three
(3),Two (2)

Specify number of distinct
cytogenetic abnormalities

Four or more (4 or more),One (1),Three (3),Two (2)

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Specify number of distinct cytogenetic
abnormalities

del(11q) / 11q-,del(12p) / 12p-,del(20q) / 20q,del(5q) / 5q-,del(7q) / 7q-,del(13q) / 13q,dup(1),i17q,inv(3),-5,-7,-Y,Other
Specify abnormalities (check all that abnormality,t(1;any),t(11q23;any),t(12p11.2;any),
apply)
t(3q21;any),t(6;9),+8,+9

Specify other abnormality:
Was documentation submitted to
the CIBMTR? (e.g. karyotyping
report)

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

del(11q) / 11q-,del(12p) / 12p-,del(20q) /
20q-,del(5q) / 5q-,del(7q) / 7q-,del(13q)
/ 13q-,dup(1),i17q,inv(3),-5,-7,-Y,Other
abnormality,t(1;any),t(11q23;any),t(12p
Specify abnormalities (check all that apply) 11.2;any),t(3q21;any),t(6;9),+8,+9

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Specify other abnormality:

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

yes

Was documentation submitted to the
CIBMTR? (e.g. karyotyping report)

open text

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

no

What was the disease status?

No,Yes
Clinical improvement (CI),Complete
clinical remission (CR),Not
assessed,Partial clinical remission
(PR),Progressive disease,Relapse,Stable
disease (SD)

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

no

Was an anemia response achieved?

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

no

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

open text

No,Yes

What was the disease status?

Clinical improvement (CI),Complete clinical
remission (CR),Not assessed,Partial clinical
remission (PR),Progressive disease,Relapse,Stable
disease (SD)

No,Yes

Was an anemia response achieved?

No,Yes

Was a spleen response achieved?

No,Yes

Was a spleen response achieved?

No,Yes

no

Was a symptom response achieved?

No,Yes

Was a symptom response achieved? No,Yes

no

Date assessed:

Date assessed:

YYYY/MM/DD

Specify the cytogenetic response

Complete response (CR Eradication of pre-existing
abnormality,Not assessed,Not applicable,None of
the above: Does not meet the CR or PR criteria,
Partial response (PR) ≥ 50% reduction in abnormal
metaphases ,Re-emergence of pre-existing
cytogenetic abnormality

Date assessed:

YYYY/MM/DD

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

no

Specify the cytogenetic response

YYYY/MM/DD
Complete response (CR Eradication of
pre-existing abnormality,Not
assessed,Not applicable,None of the
above: Does not meet the CR or PR
criteria, Partial response (PR) ≥ 50%
reduction in abnormal metaphases ,Reemergence of pre-existing cytogenetic
abnormality

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

no

Date assessed:

YYYY/MM/DD

Specify the molecular response

Complete response (CR): Eradication of preexisting abnormality ,Not assessed,Not
applicable,None of the above: Does not meet the
CR or PR criteria ,Partial response (PR): ≥50%
decrease in allele burden ,Re-emergence of a preexisting molecular abnormality

Date assessed:

YYYY/MM/DD

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

no

Specify the molecular response

Complete response (CR): Eradication of
pre-existing abnormality ,Not
assessed,Not applicable,None of the
above: Does not meet the CR or PR
criteria ,Partial response (PR): ≥50%
decrease in allele burden ,Re-emergence
of a pre-existing molecular abnormality

Disease
Classification

Myeloproliferative
Neoplasms (MPN) yes

no

Date assessed:

YYYY/MM/DD

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Rationale for Information Collection Update

Page 36 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Disease
Classification
Disease
Classification
Disease
Classification

Other Leukemia
(OL)
Other Leukemia
(OL)
Other Leukemia
(OL)

Disease
Classification

Other Leukemia
(OL)

Disease
Classification

Other Leukemia
(OL)

Disease
Classification
Disease
Classification

Other Leukemia
(OL)
Other Leukemia
(OL)

Disease
Classification
Disease
Classification

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Specify the other leukemia
classification

Chronic lymphocytic leukemia (CLL), NOS,Chronic
lymphocytic leukemia (CLL), B-cell / small
lymphocytic lymphoma (SLL),Hairy cell
leukemia,Hairy cell leukemia variant,Monoclonal Bcell lymphocytosis,Other leukemia,Other
leukemia, NOS,PLL, B-cell,Prolymphocytic
leukemia (PLL), NOS,PLL, T-cell
open text

yes

no

Specify the other leukemia classification

Chronic lymphocytic leukemia (CLL),
NOS,Chronic lymphocytic leukemia (CLL),
B-cell / small lymphocytic lymphoma
(SLL),Hairy cell leukemia,Hairy cell
leukemia variant,Monoclonal B-cell
lymphocytosis,Other leukemia,Other
leukemia, NOS,PLL, Bcell,Prolymphocytic leukemia (PLL),
NOS,PLL, T-cell

yes

no

Specify other leukemia:

open text

Specify other leukemia:

yes

no

Was any 17p abnormality detected?

no,yes

no

Did a histologic transformation to diffuse
large B-cell lymphoma (Richter syndrome)
occur at any time after CLL diagnosis?
no,yes

Was any 17p abnormality detected? no,yes
Did a histologic transformation to
diffuse large B-cell lymphoma
(Richter syndrome) occur at any time
after CLL diagnosis?
no,yes

yes

Rationale for Information Collection Update

no

What was the disease status? (Atypical
CML)

yes

no

What was the disease status? (CLL, PLL,
Hairy cell leukemia, Other leukemia)

1st complete remission (no previous
bone marrow or extramedullary
relapse),1st relapse,2nd complete
remission,2nd relapse,≥3rd complete
remission,≥3rd relapse,No
treatment,Primary induction failure
Complete remission (CR),Not
assessed,Untreated,Partial remission
(PR),Progressive disease (Prog),Stable
disease (SD)

yes

no

Date assessed:

YYYY/MM/DD
Hodgkin
Lymphoma

Date assessed:

no

Specify the lymphoma histology

Hodgkin lymphoma, not otherwise
specified (150)
Lymphocyte depleted (154)
Lymphocyte-rich (151)
Mixed cellularity (153)
Nodular lymphocyte predominant
Hodgkin lymphoma (155)
Nodular sclerosis (152)
Non-Hodgkin Lymphoma
B-cell Neoplasms
ALK+ large B-cell lymphoma (1833)
B-cell lymphoma, unclassifiable, with
features intermediate between DLBCL
and classical Hodgkin lymphoma (149)
Burkitt lymphoma (111)
Burkitt-like lymphoma with 11q
aberration (1834)
Diffuse, large B-cell lymphomaActivated B-cell type (non-GCB) (1821)
Diffuse, large B-cell lymphoma- Germinal
center B-cell type (1820)
Diffuse large B-cell Lymphoma (cell of
origin unknown) (107)
DLBCL associated with chronic
inflammation (1825)
Duodenal-type follicular lymphoma
(1815)
Change/Clarification of Response Options

Specify the lymphoma histology

YYYY/MM/DD
Classical
Hodgkin Lymphoma
Lymphocyte depleted (154)
Lymphocyte-rich (151)
Mixed cellularity (153)
Nodular sclerosis (152)
Other Classical Hodgkin Lymphoma
Hodgkin lymphoma, not otherwise specified (150)
Nodular lymphocyte predominant Hodgkin
lymphoma
Non-Hodgkin
Lymphoma
B-cell Neoplasms
ALK+ large B-cell lymphoma (1833)
B-cell lymphoma, unclassifiable, with features
intermediate between DLBCL and classical
Hodgkin lymphoma (149)
Burkitt lymphoma (111)
Burkitt-like lymphoma with 11q aberration (1834)
Diffuse, large B-cell lymphoma- Activated B-cell
type (non-GCB) (1821)
Diffuse, large B-cell lymphoma- Germinal center Bcell type (1820)
Diffuse large B-cell Lymphoma (cell of origin
unknown) (107)
DLBCL associated with chronic inflammation
(1825)
Duodenal-type follicular lymphoma (1815)
EBV+ DLBCL, NOS (1823)
EBV+ mucocutaneous ulcer (1824)
Be consistent with current clinical landscape, improve
Extranodal marginal zone B-cell lymphoma of
transplant outcome data

no

Specify other lymphoma histology:

open text

Specify other lymphoma histology:

open text

yes

Hodgkin and NonHodgkin
Lymphoma
yes
Hodgkin and NonHodgkin
Lymphoma
yes

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

What was the disease status?
(Atypical CML)

1st complete remission (no previous bone marrow
or extramedullary relapse),1st relapse,2nd
complete remission,2nd relapse,≥3rd complete
remission,≥3rd relapse,No treatment,Primary
induction failure

What was the disease status? (CLL,
PLL, Hairy cell leukemia, Other
leukemia)

Complete remission (CR),Not
assessed,Untreated,Partial remission
(PR),Progressive disease (Prog),Stable disease (SD)

Page 37 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Disease
Classification

Hodgkin and NonHodgkin
Lymphoma
yes
Hodgkin and NonHodgkin
Lymphoma
yes
Hodgkin and NonHodgkin
Lymphoma
yes

Disease
Classification

Hodgkin and NonHodgkin
Lymphoma
yes

Disease
Classification
Disease
Classification

Disease
Classification

Hodgkin and NonHodgkin
Lymphoma
yes
Hodgkin and NonHodgkin
Lymphoma
yes

Disease
Classification

Hodgkin and NonHodgkin
Lymphoma
yes

Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Hodgkin and NonHodgkin
Lymphoma
Hodgkin and NonHodgkin
Lymphoma
Hodgkin and NonHodgkin
Lymphoma
Hodgkin and NonHodgkin
Lymphoma

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Rationale for Information Collection Update

no

Assignment of DLBCL (germinal center Bcell type vs. activated B-cell type) subtype
was based on

Gene expression
profile,Immunohistochemistry (e.g.
Han’s algorithm),Unknown

no

Is the lymphoma histology reported at
transplant a transformation from CLL?

no,yes

Assignment of DLBCL (germinal
center B-cell type vs. activated B-cell
type) subtype was based on
Is the lymphoma histology reported
at transplant a transformation from
CLL?

Capture additional relevent disease information

no

Was any 17p abnormality detected?

no,yes

no

Is the lymphoma histology reported at
transplant a transformation from a
different lymphoma histology? (Not CLL)

no

Change/Clarification of Response Options

Gene expression profile,Immunohistochemistry
(e.g. Han’s algorithm),Unknown
no,yes (Also complete Chronic Lymphocytic
Leukemia (CLL) )

Specify the original lymphoma histology
(prior to transformation)

No,Yes
Aggressive NK-cell leukemia,Anaplastic
large-cell lymphoma (ALCL), ALK
negative,Anaplastic large-cell lymphoma
(ALCL), ALK positive,Angioimmunoblastic
T-cell lymphoma,Adult T-cell lymphoma
/ leukemia (HTLV1 associated),Breast
implant-associated anaplastic large-cell
lymphoma,Burkitt-like lymphoma with
11q aberration,Chronic
lymphoproliferative disorder of NK
cells,Diffuse, Large B-cell Lymphoma (cell
of origin unknown),B-cell lymphoma,
unclassifiable, with features
intermediate between DLBCL and
classical Hodgkin Lymphoma,DLBCL
associated with chronic
inflammation,EBV+ DLBCL, NOS,Diffuse,
large B-cell lymphoma- Germinal center
B-cell type,HHV8+ DLBCL, NOS,Diffuse,
large B-cell lymphoma- Activated B-cell
type (non-GCB),EBV+ mucocutaneous
ulcer,Enteropathy-type T-cell
lymphoma,Extranodal NK / T-cell
lymphoma, nasal type,Duodenal-type
follicular lymphoma,Pediatric-type
follicular lymphoma,Follicular T-cell
lymphoma,Follicular (grade
unknown),Follicular, predominantly
large cell (Grade IIIA follicle center

Was any 17p abnormality detected? no,yes
Is the lymphoma histology reported
at transplant a transformation from a
different lymphoma histology? (Not
CLL)
No,Yes
Aggressive NK-cell leukemia,Anaplastic large-cell
lymphoma (ALCL), ALK negative,Anaplastic largecell lymphoma (ALCL), ALK
positive,Angioimmunoblastic T-cell
lymphoma,Adult T-cell lymphoma / leukemia
(HTLV1 associated),Breast implant-associated
anaplastic large-cell lymphoma,Burkitt-like
lymphoma with 11q aberration,Chronic
lymphoproliferative disorder of NK cells,Diffuse,
Large B-cell Lymphoma (cell of origin unknown),Bcell lymphoma, unclassifiable, with features
intermediate between DLBCL and classical
Hodgkin Lymphoma,DLBCL associated with
chronic inflammation,EBV+ DLBCL, NOS,Diffuse,
large B-cell lymphoma- Germinal center B-cell
type,HHV8+ DLBCL, NOS,Diffuse, large B-cell
lymphoma- Activated B-cell type (non-GCB),EBV+
mucocutaneous ulcer,Enteropathy-type T-cell
lymphoma,Extranodal NK / T-cell lymphoma, nasal
type,Duodenal-type follicular lymphoma,Pediatrictype follicular lymphoma,Follicular T-cell
lymphoma,Follicular (grade unknown),Follicular,
predominantly large cell (Grade IIIA follicle center
lymphoma),Follicular, predominantly large cell
(Grade IIIB follicle center lymphoma),Follicular,
predominantly large cell (Grade IIIA vs IIIB not
specified),Follicular, predominantly small cleaved
Specify the original lymphoma
cell (Grade I follicle center lymphoma),Follicular,
histology (prior to transformation)
mixed, small cleaved and large cell (Grade II

no

Specify other lymphoma histology:

open text

Specify other lymphoma histology:

no

Date of original lymphoma diagnosis:
(report the date of diagnosis of original
lymphoma subtype)

YYYY/MM/DD

open text

Date of original lymphoma diagnosis:
(report the date of diagnosis of
original lymphoma subtype)
YYYY/MM/DD
Was a PET (or PET/CT) scan
performed? (at last evaluation prior
to the start of the preparative
regimen / infusion)
no,yes
Was the PET (or PET/CT) scan
positive for lymphoma involvement
at any disease site?
no,yes

yes

no

yes

no

Was a PET (or PET/CT) scan performed? (at
last evaluation prior to the start of the
preparative regimen / infusion)
no,yes
Was the PET (or PET/CT) scan positive for
lymphoma involvement at any disease
site?
no,yes

yes

no

Date of PET scan

Known,Unknown

Date of PET scan

Known,Unknown

yes

no

Date of PET (or PET/CT) scan:

YYYY/MM/DD

Date of PET (or PET/CT) scan:

YYYY/MM/DD

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Page 38 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification

Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Hodgkin and NonHodgkin
Lymphoma
yes

Hodgkin and NonHodgkin
Lymphoma
yes

Hodgkin and NonHodgkin
Lymphoma
yes
Hodgkin and NonHodgkin
Lymphoma
yes
Hodgkin and NonHodgkin
Lymphoma
yes

Current Information Collection Data
Element (if applicable)
Deauville (five-point) score of the PET (or
PET/CT) scan

Current Information Collection Data
Element Response Option(s)
Information Collection update:

no

Scale

no

What was the disease status?

Known,Unknown
1- no uptake or no residual uptake
2- slight uptake, but below blood pool
(mediastinum)
3- uptake above mediastinal, but below
or equal to uptake in the liver
4- uptake slightly to moderately higher
than liver
5- markedly increased uptake or any
new
CR1 -lesion
1st complete remission: no bone
marrow or extramedullary relapse prior
to transplant,CR2 - 2nd complete
remission,CR3+ - 3rd or subsequent
complete remission,PIF res - Primary
induction failure – resistant: NEVER in
COMPLETE remission but with stable or
progressive disease on treatment.,PIF
sen / PR1 - Primary induction failure –
sensitive: NEVER in COMPLETE remission
but with partial remission on
treatment.,PIF unk - Primary induction
failure – sensitivity unknown,REL1 res 1st relapse – resistant: stable or
progressive disease with treatment,REL1
sen - 1st relapse – sensitive: partial
remission (if complete remission was
achieved, classify as CR2),REL1 unk - 1st
relapse – sensitivity unknown,REL1 unt 1st relapse – untreated; includes either
bone marrow or extramedullary
relapse,REL2 res - 2nd relapse –
resistant: stable or progressive disease
with treatment,REL2 sen - 2nd relapse –
sensitive: partial remission (if complete
remission achieved, classify as
CR3+),REL2 unk - 2nd relapse –
sensitivity unknown,REL2 unt - 2nd
relapse – untreated: includes either

no

Total number of lines of therapy received
(between diagnosis and HCT / infusion)

1 line,2 lines,3+ lines

no

Date assessed:

no

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

YYYY/MM/DD
Amyloidosis,Monoclonal gammopathy
of renal significance (MGRS),Multiple
myeloma,Multiple myeloma-light chain
only,Multiple myeloma-nonsecretory,Osteosclerotic myeloma /
POEMS syndrome,Other plasma cell
disorder (PCD),Plasma cell leukemia
Specify the multiple myeloma/plasma cell (PCL),Smoldering myeloma,Solitary
disorder (PCD) classification
plasmacytoma

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Specify other plasma cell disorder:

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

open text

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Rationale for Information Collection Update

Deauville (five-point) score of the PET
(or PET/CT) scan
Known,Unknown

Scale

1- no uptake or no residual uptake
2- slight uptake, but below blood pool
(mediastinum)
3- uptake above mediastinal, but below or equal
to uptake in the liver
4- uptake slightly to moderately higher than liver
5markedly
increased
uptake or
new
lesionor
CR1
- 1st complete
remission:
noany
bone
marrow
extramedullary relapse prior to transplant,CR2 2nd complete remission,CR3+ - 3rd or subsequent
complete remission,PIF res - Primary induction
failure – resistant: NEVER in COMPLETE remission
but with stable or progressive disease on
treatment.,PIF sen / PR1 - Primary induction
failure – sensitive: NEVER in COMPLETE remission
but with partial remission on treatment.,PIF unk Primary induction failure – sensitivity
unknown,REL1 res - 1st relapse – resistant: stable
or progressive disease with treatment,REL1 sen 1st relapse – sensitive: partial remission (if
complete remission was achieved, classify as
CR2),REL1 unk - 1st relapse – sensitivity
unknown,REL1 unt - 1st relapse – untreated;
includes either bone marrow or extramedullary
relapse,REL2 res - 2nd relapse – resistant: stable or
progressive disease with treatment,REL2 sen - 2nd
relapse – sensitive: partial remission (if complete
remission achieved, classify as CR3+),REL2 unk 2nd relapse – sensitivity unknown,REL2 unt - 2nd
relapse – untreated: includes either bone marrow
or extramedullary relapse,REL3+ res - 3rd or
subsequent relapse – resistant: stable or
progressive disease with treatment,REL3+ sen 3rd or subsequent relapse – sensitive: partial
remission (if complete remission achieved, classify
as CR3+),REL3+ unk - 3rd relapse or greater –

What was the disease status?
Total number of lines of therapy
received (between diagnosis and HCT
/ infusion)
1 line,2 lines,3+ lines

Date assessed:

Specify other plasma cell disorder:

YYYY/MM/DD

Amyloidosis,Monoclonal gammopathy of renal
significance (MGRS),Multiple myeloma,Multiple
myeloma-light chain only,Multiple myeloma-nonsecretory,Osteosclerotic myeloma / POEMS
Specify the multiple
syndrome,Other plasma cell disorder (PCD),Plasma
myeloma/plasma cell disorder (PCD) cell leukemia (PCL),Smoldering myeloma,Solitary
classification
plasmacytoma

open text

Page 39 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)
IgA (heavy chain only),IgA kappa,IgA lambda,IgD
(heavy chain only),IgD kappa,IgD lambda,IgE
(heavy chain only),IgE kappa,IgE lambda,IgG
(heavy chain only),IgG kappa,IgG lambda,IgM
Specify heavy and/or light chain type (heavy chain only),IgM kappa,IgM lambda,Kappa
(check all that apply)
(light chain only),Lambda (light chain only)

Specify Amyloidosis classification

AH amyloidosis,AHL amyloidosis,AL amyloidosis

Select monoclonal gammopathy of
renal significance (MGRS)
classification

C3 glomerulopathy with monoclonal
gammopathy,Crystal-storing
histiocytosis,Immunotactoid glomerulopathy
(ITGN)/ Glomerulonephritis with organized
monoclonal microtubular immunoglobulin
deposits (GOMMID),Light chain fanconi
syndrome,Monoclonal immunoglobulin deposition
disease (MIDD),Non-amyloid fibrillary
glomerulonephritis,Proliferative
glomerulonephritis with monoclonal
immunoglobulin G deposits (PGNMID),Proximal
tubulopathy without crystals,Type 1
cryoglobulinemic glomerulonephritis,Unknown

Select monoclonal immunoglobulin
deposition disease (MIDD) subtype

Heavy chain deposition disease (HCDD),Light chain
deposition disease (LCDD),Light and heavy chain
deposition disease (LHCDD)

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Specify heavy and/or light chain type
(check all that apply)

IgA (heavy chain only),IgA kappa,IgA
lambda,IgD (heavy chain only),IgD
kappa,IgD lambda,IgE (heavy chain
only),IgE kappa,IgE lambda,IgG (heavy
chain only),IgG kappa,IgG lambda,IgM
(heavy chain only),IgM kappa,IgM
lambda,Kappa (light chain only),Lambda
(light chain only)

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Specify Amyloidosis classification

AH amyloidosis,AHL amyloidosis,AL
amyloidosis

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Select monoclonal gammopathy of renal
significance (MGRS) classification

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Select monoclonal immunoglobulin
deposition disease (MIDD) subtype

C3 glomerulopathy with monoclonal
gammopathy,Crystal-storing
histiocytosis,Immunotactoid
glomerulopathy (ITGN)/
Glomerulonephritis with organized
monoclonal microtubular
immunoglobulin deposits
(GOMMID),Light chain fanconi
syndrome,Monoclonal immunoglobulin
deposition disease (MIDD),Non-amyloid
fibrillary glomerulonephritis,Proliferative
glomerulonephritis with monoclonal
immunoglobulin G deposits
(PGNMID),Proximal tubulopathy without
crystals,Type 1 cryoglobulinemic
glomerulonephritis,Unknown
Heavy chain deposition disease
(HCDD),Light chain deposition disease
(LCDD),Light and heavy chain deposition
disease (LHCDD)

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Was documentation submitted to the
CIBMTR? (e.g. pathology report)

No,Yes

Was documentation submitted to
the CIBMTR? (e.g. pathology report) No,Yes

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Solitary plasmacytoma was

Bone derived,Extramedullary

Solitary plasmacytoma was

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

What was the Durie-Salmon staging? (at
diagnosis)

no

What was the Durie-Salmon sub
classification? (at diagnosis)

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Stage I (All of the following: Hgb >
10g/dL; serum calcium normal or <10.5
mg/dL; bone x-ray normal bone
structure (scale 0), or solitary bone
plasmacytoma only; low M-component
production rates IgG < 5g/dL, IgA <
3g/dL; urine light chain M-component
on electrophoresis <4g/24h) – ,Stage II
(Fitting neither Stage I or Stage III) ,Stage
III (One of more of the following: Hgb <
8.5 g/dL; serum calcium > 12 mg/dL;
advanced lytic bone lesions (scale 3);
high M-component production rates IgG
>7g/dL, IgA > 5g/dL; Bence Jones protein
>12g/24h) ,Unknown
A - relatively normal renal function
(serum creatinine < 2.0 mg/dL,B abnormal renal function (serum
creatinine ≥ 2.0 mg/dL)

Rationale for Information Collection Update

Bone derived,Extramedullary

Stage I (All of the following: Hgb > 10g/dL; serum
calcium normal or <10.5 mg/dL; bone x-ray normal
bone structure (scale 0), or solitary bone
plasmacytoma only; low M-component
production rates IgG < 5g/dL, IgA < 3g/dL; urine
light chain M-component on electrophoresis
<4g/24h) – ,Stage II (Fitting neither Stage I or
Stage III) ,Stage III (One of more of the following:
Hgb < 8.5 g/dL; serum calcium > 12 mg/dL;
advanced lytic bone lesions (scale 3); high MWhat was the Durie-Salmon staging? component production rates IgG >7g/dL, IgA >
(at diagnosis)
5g/dL; Bence Jones protein >12g/24h) ,Unknown

What was the Durie-Salmon sub
classification? (at diagnosis)

A - relatively normal renal function (serum
creatinine < 2.0 mg/dL,B - abnormal renal function
(serum creatinine ≥ 2.0 mg/dL)

Page 40 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Did the recipient have a preceding or
concurrent plasma cell disorder?

No,Yes

Did the recipient have a preceding or
concurrent plasma cell disorder?
No,Yes

Specify preceding / concurrent
disorder

Amyloidosis,Monoclonal gammopathy of renal
significance,Monoclonal gammopathy of unknown
significance,Multiple myeloma,Multiple myeloma light chain only,Multiple myeloma - nonsecretory,Osteosclerotic myeloma / POEMS
syndrome,Other disease,Plasma cell
leukemia,Smoldering myeloma,Solitary
plasmacytoma

Specify other preceding/concurrent
disorder:

open text

yes

yes

Specify preceding / concurrent disorder

Amyloidosis,Monoclonal gammopathy
of renal significance,Monoclonal
gammopathy of unknown
significance,Multiple myeloma,Multiple
myeloma - light chain only,Multiple
myeloma - non-secretory,Osteosclerotic
myeloma / POEMS syndrome,Other
disease,Plasma cell leukemia,Smoldering
myeloma,Solitary plasmacytoma

yes

yes

Specify other preceding/concurrent
disorder:

open text

Disease
Classification

Preceding or
Concurrent
Plasma Cell
Disorder
Preceding or
Concurrent
Plasma Cell
Disorder
Preceding or
Concurrent
Plasma Cell
Disorder

yes

yes

Date of diagnosis of preceding / concurrent
disorder:
YYYY/MM/DD

Date of diagnosis of preceding /
concurrent disorder:

YYYY/MM/DD

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Serum beta2 - microglobulin

Known,Unknown

Serum beta2 - microglobulin

Known,Unknown

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Serum beta2-microglobulin:

: ___ ___ ___ ● ___ ___ ___
: ___ ___ ___ ● ___ ___ ___
: ___ ___ ___ ● ___ ___ ___

Serum beta2-microglobulin:

: ___ ___ ___ ● ___ ___ ___
: ___ ___ ___ ● ___ ___ ___
: ___ ___ ___ ● ___ ___ ___

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Serum albumin

Known,Unknown

Serum albumin

Known,Unknown

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Serum albumin:

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

I.S.S Stage

Known,Unknown

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

I.S.S Stage

1 (Serum β2-microglobulin < 3.5 mg/L,
Serum albumin ≥ 3.5 g/dL), 2(Not fitting
stage 1 or 3) ,3 (Serum β2-microglobulin
≥ 5.5 mg/L; Serum albumin —)

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

R-I.S.S Stage

Disease
Classification

Disease
Classification

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

μg/dL
mg/L
nmol/L

: ___ ___ ● ___ g/dL
: ___ ___ ● ___ g/L

no

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

R-I.S.S Stage

Rationale for Information Collection Update

μg/dL
mg/L
nmol/L

: ___ ___ ● ___ g/dL
: ___ ___ ● ___ g/L
Serum albumin:

Known,Unknown
1 (ISS stage I and no high-risk
cytogenetic abnormalities by FISH
[deletion 17p / 17p-, t(4;14), t(14;16)]
and normal LDH levels),2(Not R-ISS stage
I or III),3(ISS stage III and either high-risk
cytogenetic abnormalities by FISH
[deletion 17p / 17p-, t(4;14), t(14;16)] or
high LDH levels)

I.S.S Stage

Known,Unknown

I.S.S Stage

1 (Serum β2-microglobulin < 3.5 mg/L, Serum
albumin ≥ 3.5 g/dL), 2(Not fitting stage 1 or 3) ,3
(Serum β2-microglobulin ≥ 5.5 mg/L; Serum
albumin —)

R-I.S.S Stage

Known,Unknown

R-I.S.S Stage

1 (ISS stage I and no high-risk cytogenetic
abnormalities by FISH [deletion 17p / 17p-, t(4;14),
t(14;16)] and normal LDH levels),2(Not R-ISS stage
I or III),3(ISS stage III and either high-risk
cytogenetic abnormalities by FISH [deletion 17p /
17p-, t(4;14), t(14;16)] or high LDH levels)

Page 41 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

Disease
Classification

no

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Rationale for Information Collection Update

Plasma cells in blood by flow cytometry

Known,Unknown

Plasma cells in peripheral blood by
flow cytometry

Capture data accurately

Plasma cells in blood by flow cytometry

___ ___• ___ ___ %

Plasma cells in blood by morphologic
assessment

Known,Unknown

Plasma cells in blood by morphologic
assessment

___ ___• ___ ___ %

Change/Clarification of Information Requested

Plasma cells in blood by flow
cytometry

Change/Clarification of Information Requested

Plasma cells in peripheral blood by
morphologic assessment

Known,Unknown
___ ___• ___ ___ %

Known,Unknown

Capture data accurately

Plasma cells in blood by morphologic
___ ___• ___ ___ %
assessment

no

no

Plasma cells in blood by morphologic
assessment

___ ___ ___ ___ ___ • ___ ___ □ x
109/L (x 103/mm3)
___ ___ ___ ___ ___ • ___ ___ □ x
106/L

___ ___ ___ ___ ___ • ___ ___ □ x 109/L (x
Plasma cells in blood by morphologic 103/mm3)
assessment
___ ___ ___ ___ ___ • ___ ___ □ x 106/L

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

LDH

Known,Unknown

LDH

Known,Unknown

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

LDH

___ ___ ___ ___ ___ ● ___ ___ o U/L
___ ___ ___ ___ ___ ● ___ ___ o μkat/L

LDH

___ ___ ___ ___ ___ ● ___ ___ o U/L
___ ___ ___ ___ ___ ● ___ ___ o μkat/L

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Upper limit of normal for LDH:

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Were cytogenetics tested (karyotyping or
FISH)? (at diagnosis)

no,Unknown,yes

Were cytogenetics tested
(karyotyping or FISH)? (at diagnosis) no,Unknown,yes

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Were cytogenetics tested via FISH?

No,Yes

Were cytogenetics tested via FISH?

No,Yes

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Results of tests

Abnormalities identified,No
abnormalities

Results of tests

Abnormalities identified,No abnormalities

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

open text

International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

open text

Any abnormality at 1p,Any abnormality at
1q,del(13q) / 13q-,del(17p) / 17p-,Hyperdiploid (>
50),Hypodiploid (< 46),-13,-17,MYC
rearrangement,Other
Specify abnormalities (check all that abnormality,t(11;14),t(14;16),t(14;20),t(4;14),t(6;1
apply)
4),+11,+15,+19,+3,+5,+7,+9

___ ___ ___ ___ ___ • ___ ___

___ ___ ___ ___ ___ • ___ ___

Upper limit of normal for LDH:

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Any abnormality at 1p,Any abnormality
at 1q,del(13q) / 13q-,del(17p) / 17p,Hyperdiploid (> 50),Hypodiploid (< 46),13,-17,MYC rearrangement,Other
abnormality,t(11;14),t(14;16),t(14;20),t(
Specify abnormalities (check all that apply) 4;14),t(6;14),+11,+15,+19,+3,+5,+7,+9

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Specify other abnormality:

open text

Specify other abnormality:

open text

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Was documentation submitted to the
CIBMTR? (e.g. FISH report)

No,Yes

Was documentation submitted to
the CIBMTR? (e.g. FISH report)

No,Yes

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Page 42 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Were cytogenetics tested via karyotyping? No,Yes

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Results of tests

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

Any abnormality at 1p,Any abnormality at
1q,del(13q) / 13q-,del(17p) / 17p-,Hyperdiploid (>
50),Hypodiploid (< 46),-13,-17,MYC
rearrangement,Other
Specify abnormalities (check all that abnormality,t(11;14),t(14;16),t(14;20),t(4;14),t(6;1
apply)
4),+11,+15,+19,+3,+5,+7,+9

Specify other abnormality:

open text

Was documentation submitted to
the CIBMTR? (e.g. karyotyping
report)

No,Yes

What is the hematologic disease
status?

Complete remission (CR),Progressive disease
(PD),Partial remission (PR),Relapse from CR (Rel)
(untreated),Stringent complete remission
(sCR),Stable disease (SD),Unknown,Very good
partial remission (VGPR)

Date assessed:

YYYY/MM/DD

Date assessed:

Were cytogenetics tested via
karyotyping?

No,Yes

Abnormalities identified,No
abnormalities,No evaluable metaphases

Results of tests

Abnormalities identified,No abnormalities,No
evaluable metaphases

open text

International System for Human
Cytogenetic Nomenclature (ISCN)
compatible string:

open text

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Any abnormality at 1p,Any abnormality
at 1q,del(13q) / 13q-,del(17p) / 17p,Hyperdiploid (> 50),Hypodiploid (< 46),13,-17,MYC rearrangement,Other
abnormality,t(11;14),t(14;16),t(14;20),t(
Specify abnormalities (check all that apply) 4;14),t(6;14),+11,+15,+19,+3,+5,+7,+9

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Specify other abnormality:

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Was documentation submitted to the
CIBMTR? (e.g. karyotyping report)

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

What is the hematologic disease status?

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Date assessed:

open text

No,Yes
Complete remission (CR),Progressive
disease (PD),Partial remission
(PR),Relapse from CR (Rel)
(untreated),Stringent complete
remission (sCR),Stable disease
(SD),Unknown,Very good partial
remission (VGPR)

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

YYYY/MM/DD
Complete response (CR),No response
(NR) / stable disease (SD),Progressive
disease (PD),Partial response
(PR),Relapse from CR (Rel)
Specify amyloidosis hematologic response (untreated),Unknown,Very good partial
(for Amyloid patients only)
response (VGPR)

Disease
Classification

Multiple Myeloma
/ Plasma Cell
Disorder (PCD)
yes

no

Date assessed:

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

YYYY/MM/DD

Rationale for Information Collection Update

Complete response (CR),No response (NR) / stable
disease (SD),Progressive disease (PD),Partial
response (PR),Relapse from CR (Rel)
Specify amyloidosis hematologic
(untreated),Unknown,Very good partial response
response (for Amyloid patients only) (VGPR)

YYYY/MM/DD

Page 43 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Disease
Classification
Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Breast cancer,Bone sarcoma (excluding Ewing
family tumors),Cervical,Central nervous system
tumor, including CNS PNET,Colorectal,Ovarian
(epithelial),Ewing family tumors, extraosseous
(including PNET),Ewing family tumors of bone
(including PNET),External
genitalia,Fibrosarcoma,Gastric,Germ cell tumor,
extragonadal,Hepatobiliary,Head /
neck,Hemangiosarcoma,Lung, not otherwise
specified,Leiomyosarcoma,Lymphangio
sarcoma,Liposarcoma,Medulloblastoma,Mediastin
al
neoplasm,Melanoma,Neuroblastoma,Neurogenic
sarcoma,Lung, non-small cell,Other solid
tumor,Prostate,Renal
cell,Retinoblastoma,Rhabdomyosarcoma,Lung,
small cell,Synovial sarcoma,Solid tumor, not
otherwise specified,Pancreatic,Soft tissue sarcoma
(excluding Ewing family
tumors),Testicular,Thymoma,Uterine,Vaginal,Wil
Specify the solid tumor classification m Tumor
Specify other solid tumor:

Solid Tumors

yes

no

Specify the solid tumor classification

Breast cancer,Bone sarcoma (excluding
Ewing family tumors),Cervical,Central
nervous system tumor, including CNS
PNET,Colorectal,Ovarian
(epithelial),Ewing family tumors,
extraosseous (including PNET),Ewing
family tumors of bone (including
PNET),External
genitalia,Fibrosarcoma,Gastric,Germ cell
tumor, extragonadal,Hepatobiliary,Head
/ neck,Hemangiosarcoma,Lung, not
otherwise
specified,Leiomyosarcoma,Lymphangio
sarcoma,Liposarcoma,Medulloblastoma,
Mediastinal
neoplasm,Melanoma,Neuroblastoma,Ne
urogenic sarcoma,Lung, non-small
cell,Other solid tumor,Prostate,Renal
cell,Retinoblastoma,Rhabdomyosarcom
a,Lung, small cell,Synovial sarcoma,Solid
tumor, not otherwise
specified,Pancreatic,Soft tissue sarcoma
(excluding Ewing family
tumors),Testicular,Thymoma,Uterine,Va
ginal,Wilm Tumor

Solid Tumors

yes

no

Specify other solid tumor:

open text

Acquired amegakaryocytosis (not
congenital),Acquired pure red cell
aplasia (not congenital),Acquired AA,
not otherwise specified,Other acquired
cytopenic syndrome,Acquried AA
secondary to chemotherapy,Acquired
Specify the aplastic anemia classification – AA, secondary to hepatitis,Acquired AA
If the recipient developed MDS or AML,
secondary to immunotherapy or
indicate MDS or AML as the primary
immune effector cell therapy,Acquired
disease.
AA, secondary to toxin / other drug

Acquired amegakaryocytosis (not
congenital),Acquired pure red cell aplasia (not
congenital),Acquired AA, not otherwise
specified,Other acquired cytopenic
syndrome,Acquried AA secondary to
chemotherapy,Acquired AA, secondary to
Specify the aplastic anemia
hepatitis,Acquired AA secondary to
classification – If the recipient
immunotherapy or immune effector cell
developed MDS or AML, indicate
therapy,Acquired AA, secondary to toxin / other
MDS or AML as the primary disease. drug

Specify severity
Specify other acquired cytopenic
syndrome:

Specify severity
Specify other acquired cytopenic
syndrome:

Aplastic Anemia

yes

no

Aplastic Anemia

yes

no

Aplastic Anemia

yes

no

yes

no

yes

no

Disease
Classification

Inherited Bone
Marrow Failure
Syndromes
Inherited Bone
Marrow Failure
Syndromes

Disease
Classification

Hemoglobinopathi
es
yes

Disease
Classification
Disease
Classification

Hemoglobinopathi
es
yes
Hemoglobinopathi
es
yes

Disease
Classification

Hemoglobinopathi
es
yes

Disease
Classification

Current Information Collection Data
Element (if applicable)

Not severe,Severe / very severe

no

open text
Dyskeratosis congenita,Fanconi
anemia,Severe congenital
Specify the inherited bone marrow failure neutropenia,Diamond-Blackfan
syndrome classification
anemia,Shwachman-Diamond
Did the recipient receive gene therapy to
treat the inherited bone marrow failure
syndrome?
No,Yes
Other hemoglobinopathy,Sickle cell
Specify the hemoglobinopathy
disease,Transfusion dependent
classification
thalassemia
Transfusion dependent beta
thalassemia,Other transfusion
Specify transfusion dependent thalassemia dependent thalassemia

no

Specify other hemoglobinopathy:

open text

no

Did the recipient receive gene therapy to
treat the hemoglobinopathy?

No,Yes

no

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Change/Clarification of Response Options

Deletion of Information Requested

Deletion of Information Requested

Specify the inherited bone marrow
failure syndrome classification
Did the recipient receive gene
therapy to treat the inherited bone
marrow failure syndrome?

Rationale for Information Collection Update

open text

Not severe,Severe / very severe
open text
Dyskeratosis congenita,Fanconi anemia,Severe
congenital neutropenia,Diamond-Blackfan
anemia,Shwachman-Diamond, Other inherited
bone failure syndromes

Be consistent with current clinical landscape, improve
transplant outcome data

No,Yes

Reduce redundancy in data capture

Specify the hemoglobinopathy
classification

Other hemoglobinopathy,Sickle cell
disease,Transfusion dependent thalassemia

Specify transfusion dependent
thalassemia

Transfusion dependent beta thalassemia,Other
transfusion dependent thalassemia

Specify other hemoglobinopathy:
Did the recipient receive gene
therapy to treat the
hemoglobinopathy?

open text

No,Yes

Reduce redundancy in data capture

Page 44 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Disease
Classification
Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification

Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

yes

no

Was tricuspid regurgitant jet velocity
(TRJV) measured by echocardiography?

No,Unknown,Yes

Was tricuspid regurgitant jet velocity
(TRJV) measured by
echocardiography?
No,Unknown,Yes

yes

no

TRJV measurement

Known,Unknown

TRJV measurement

yes

no

yes

no

TRJV measurement:
Was liver iron content (LIC) tested within 6
months prior to infusion?
No,Yes

Hemoglobinopathi
es
yes
Hemoglobinopathi
es
yes

Hemoglobinopathi
es
yes
Hemoglobinopathi
es
yes
Hemoglobinopathi
es
yes

__ __ ● ___ m/sec

no

Liver iron content:

no

Method used to estimate LIC?

___ ___ ___ ● ___mg Fe/g liver dry
weight
___ ___ ___ ● ___g Fe/kg liver dry
weight
___ ___ ___ ● ___µmol Fe / g liver dry
weight
FerriScan,Liver Biopsy,Other,SQUID
MRI,T2 MRI

no

Is the recipient red blood cell transfusion
dependent? (requiring transfusion to
maintain HGB 9-10 g/dL)

No,Yes

Known,Unknown
__ __ ● ___ m/sec

No,Yes

___ ___ ___ ● ___mg Fe/g liver dry weight
___ ___ ___ ● ___g Fe/kg liver dry weight
___ ___ ___ ● ___µmol Fe / g liver dry weight
Liver iron content:
Method used to estimate LIC?
Is the recipient red blood cell
transfusion dependent? (requiring
transfusion to maintain HGB 9-10
g/dL)
Year of first transfusion: (since
diagnosis):
Was iron chelation therapy given at
any time since diagnosis?

FerriScan,Liver Biopsy,Other,SQUID MRI,T2 MRI

No,Yes

no

Year of first transfusion: (since diagnosis):
Was iron chelation therapy given at any
time since diagnosis?

yes

no

Did iron chelation therapy meet the
following criteria: initiated within 18
months of the first transfusion and
administered for at least 5 days / week
(either oral or parenteral iron chelation
medication)?

yes

no

Specify reason criteria not met

No, iron chelation therapy given, but not
meeting criteria,Iron chelation therapy
given, but details of administration
unknown,Yes, iron chelation therapy
given as specified
Non-adherence,Other,Toxicity due to
iron chelation therapy

yes

no

Specify other reason criteria not met:

open text

Specify other reason criteria not met: open text

yes

no

Year iron chelation therapy started

Known,Unknown

Year iron chelation therapy started

Known,Unknown

YYYY

YYYY

no,yes

Year started:
Did the recipient have
hepatomegaly? (≥ 2 cm below costal
margin)
Liver size as measured below the
costal margin at most recent
evaluation:
Was a liver biopsy performed at any
time since diagnosis?

no

YYYY

TRJV measurement:
Was liver iron content (LIC) tested
within 6 months prior to infusion?

No,Unknown,Yes

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es

yes

no

Year started:

Disease
Classification

Hemoglobinopathi
es
yes

no

Did the recipient have hepatomegaly? (≥ 2
cm below costal margin)
no,Unknown,yes

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es

Did iron chelation therapy meet the
following criteria: initiated within 18
months of the first transfusion and
administered for at least 5 days /
week (either oral or parenteral iron
chelation medication)?
Specify reason criteria not met

YYYY
No,Unknown,Yes

No, iron chelation therapy given, but not meeting
criteria,Iron chelation therapy given, but details of
administration unknown,Yes, iron chelation
therapy given as specified
Non-adherence,Other,Toxicity due to iron
chelation therapy

no,Unknown,yes

yes

no

yes

no

Liver size as measured below the costal
margin at most recent evaluation:
Was a liver biopsy performed at any time
since diagnosis?

yes

no

Date functional status assessed

Known,Unknown

Date functional status assessed

Known,Unknown

yes

no

Date assessed:

YYYY/MM/DD

Date assessed:

YYYY/MM/DD

yes

no

Date estimated

checked

Date estimated

checked

yes

no

Was there evidence of liver cirrhosis?

No,Unknown,Yes

Was there evidence of liver cirrhosis? No,Unknown,Yes

yes

no

Was there evidence of liver fibrosis?

No,Unknown,Yes

Was there evidence of liver fibrosis? No,Unknown,Yes

yes

no

Type of fibrosis

Bridging,Other,Periportal,Unknown

yes

no

Was there evidence of chronic hepatitis?

No,Unknown,Yes

Type of fibrosis
Was there evidence of chronic
hepatitis?

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

__ __ cm

Rationale for Information Collection Update

__ __ cm
no,yes

Bridging,Other,Periportal,Unknown
No,Unknown,Yes

Page 45 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Disease
Classification

Hemoglobinopathi
es
yes

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es
Hemoglobinopathi
es

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Disorders of the
Immune System
Disorders of the
Immune System
Disorders of the
Immune System
Disorders of the
Immune System

Disease
Classification

Disorders of the
Immune System

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

No,Yes

Was documentation submitted to
the CIBMTR? (e.g. liver biopsy)

no

Was documentation submitted to the
CIBMTR? (e.g. liver biopsy)

yes

no

Is there evidence of abnormal cardiac iron
deposition based on MRI of the heart at
time of infusion?
No,Yes

yes

no

Did the recipient have a splenectomy?

no,Unknown,yes

yes

no

Serum iron

no

Serum iron:

Known,Unknown
: ___ ___ ___● ___ ___ µg / dL
: ___ ___ ___● ___ ___µmol / L

Serum iron

yes
yes

no

Total iron binding capacity (TIBC)

Total iron binding capacity (TIBC)

yes

no

TIBC:

Known,Unknown
: ___ ___ ___● ___ ___ µg / dL
: ___ ___ ___● ___ ___µmol / L

yes

no

Total serum bilirubin

no

yes

no

Total serum bilirubin:
Upper limit of normal for total serum
bilirubin:

Known,Unknown
: ___ ___ ___● ___ ___ mg/dL
: ___ ___ ___● ___ ___µmol / L

Total serum bilirubin

yes

__ __ __ ● __

No,Yes

Is there evidence of abnormal cardiac
iron deposition based on MRI of the
heart at time of infusion?
No,Yes
Did the recipient have a
splenectomy?
no,Unknown,yes

Serum iron:

TIBC:

Known,Unknown
: ___ ___ ___● ___ ___ µg / dL
: ___ ___ ___● ___ ___µmol / L
Known,Unknown
: ___ ___ ___● ___ ___ µg / dL
: ___ ___ ___● ___ ___µmol / L

Known,Unknown
: ___ ___ ___● ___ ___ mg/dL
Total serum bilirubin:
: ___ ___ ___● ___ ___µmol / L
Upper limit of normal for total serum
__ __ __ ● __
bilirubin:

yes

no

Specify disorder of immune system
classification

Ataxia telangiectasia,Bare lymphocyte
syndrome,Cartilage hair
hypoplasia,CD40 ligand
deficiency,Chronic granulomatous
disease,DiGeorge anomaly,Griscelli
syndrome type 2,HIV
infection,Hermansky-Pudlak syndrome
type 2,Leukocyte adhesion deficiencies,
including GP180, CD-18, LFA and WBC
adhesion deficiencies,Neutrophil actin
deficiency,Chediak-Higashi
syndrome,Other
immunodeficiencies,Omenn
syndrome,Other pigmentary dilution
disorder,Other SCID,Reticular
dysgenesis,Adenosine deaminase (ADA)
deficiency / severe combined
immunodeficiency (SCID),SCID, not
otherwise specified,Absence of T and B
cells SCID,Absence of T, normal B cell
SCID,Immune deficiency, not otherwise
specified,Common variable
immunodeficiency,Wiskott-Aldrich
syndrome,X-linked lymphoproliferative
syndrome

yes

no

Specify other SCID:

open text

Specify other SCID:

open text

yes

no

Specify other immunodeficiency:

open text

open text

yes

no

yes

no

Specify other pigmentary dilution disorder: open text
Did the recipient have an active or recent
infection with a viral pathogen within 60
days of HCT?
No,Yes

Specify other immunodeficiency:
Specify other pigmentary dilution
disorder:
Did the recipient have an active or
recent infection with a viral
pathogen within 60 days of HCT?

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Rationale for Information Collection Update

Specify disorder of immune system
classification

Ataxia telangiectasia,Bare lymphocyte
syndrome,Cartilage hair hypoplasia,CD40 ligand
deficiency,Chronic granulomatous
disease,DiGeorge anomaly,Griscelli syndrome type
2,HIV infection,Hermansky-Pudlak syndrome type
2,Leukocyte adhesion deficiencies, including
GP180, CD-18, LFA and WBC adhesion
deficiencies,Neutrophil actin deficiency,ChediakHigashi syndrome,Other
immunodeficiencies,Omenn syndrome,Other
pigmentary dilution disorder,Other SCID,Reticular
dysgenesis,Adenosine deaminase (ADA) deficiency
/ severe combined immunodeficiency (SCID),SCID,
not otherwise specified,Absence of T and B cells
SCID,Absence of T, normal B cell SCID,Immune
deficiency, not otherwise specified,Common
variable immunodeficiency,Wiskott-Aldrich
syndrome,X-linked lymphoproliferative syndrome

open text

No,Yes

Page 46 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Disease
Classification
Disease
Classification

Disorders of the
Immune System
Disorders of the
Immune System

Disease
Classification

Disorders of the
Immune System

Disease
Classification
Disease
Classification

Inherited
Abnormalities of
Platelets
Inherited
Abnormalities of
Platelets

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:
Adenovirus,BK Virus,Chikaugunya
Virus,Cytomegalovirus
(CMV),Coronavirus,Dengue Virus,EpsteinBarr Virus (EBV),Enterovirus D68 (EVD68),Enterovirus (ECHO,
Coxsackie),Enterovirus, NOS,Enterovirus
(polio),Hepatitis A Virus,Hepatitis B
Virus,Hepatitis C Virus,Hepatitis
E,Human herpesvirus 6 (HHV-6),Human
Immunodeficiency Virus 1 or 2,Human
metapneumovirus,Human
Papillomavirus (HPV),Herpes Simplex
Virus (HSV),Human T-lymphotropic Virus
1 or 2,Influenza A Virus,Influenza B
Virus,Influenza, NOS,JC Virus
(Progressive Multifocal
Leukoencephalopathy (PML)),Measles
Virus (Rubeola),Mumps
Virus,Norovirus,Human Parainfluenza
Virus (all species),Rhinovirus (all
species),Rotavirus (all
species),Respiratory Syncytial Virus
(RSV),Rubella Virus,Varicella Virus,West
Nile Virus (WNV)

yes

no

Specify viral pathogen (check all that
apply)
Has the recipient ever been infected with
PCP / PJP?
No,Yes
Does the recipient have GVHD due to
maternal cell engraftment pre-HCT? (SCID
only)
No,Yes
Congenital amegakaryocytosis /
congenital thrombocytopenia
(501),Glanzmann thrombasthenia
Specify inherited abnormalities of platelets (502),Other inherited platelet
classification
abnormality (509)

yes

no

Specify other inherited platelet
abnormality:

yes

no

yes

no

yes

no

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

open text

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Rationale for Information Collection Update

Adenovirus,BK Virus,Chikaugunya
Virus,Cytomegalovirus (CMV),Coronavirus,Dengue
Virus,Epstein-Barr Virus (EBV),Enterovirus D68 (EVD68),Enterovirus (ECHO, Coxsackie),Enterovirus,
NOS,Enterovirus (polio),Hepatitis A Virus,Hepatitis
B Virus,Hepatitis C Virus,Hepatitis E,Human
herpesvirus 6 (HHV-6),Human Immunodeficiency
Virus 1 or 2,Human metapneumovirus,Human
Papillomavirus (HPV),Herpes Simplex Virus
(HSV),Human T-lymphotropic Virus 1 or
2,Influenza A Virus,Influenza B Virus,Influenza,
NOS,JC Virus (Progressive Multifocal
Leukoencephalopathy (PML)),Measles Virus
(Rubeola),Mumps Virus,Norovirus,Human
Parainfluenza Virus (all species),Rhinovirus (all
species),Rotavirus (all species),Respiratory
Specify viral pathogen (check all that Syncytial Virus (RSV),Rubella Virus,Varicella
apply)
Virus,West Nile Virus (WNV)
Has the recipient ever been infected
with PCP / PJP?
No,Yes
Does the recipient have GVHD due to
maternal cell engraftment pre-HCT?
(SCID only)
No,Yes

Specify inherited abnormalities of
platelets classification

Congenital amegakaryocytosis / congenital
thrombocytopenia (501),Glanzmann
thrombasthenia (502),Other inherited platelet
abnormality (509)

Specify other inherited platelet
abnormality:

open text

Page 47 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Disease
Classification
Disease
Classification
Disease
Classification

Inherited
Disorders of
Metabolism
Inherited
Disorders of
Metabolism
Inherited
Disorders of
Metabolism

Disease
Classification
Disease
Classification

Histiocytic
Disorders
Histiocytic
Disorders

Disease
Classification

Histiocytic
Disorders

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:
Adrenoleukodystrophy (ALD)
(543),Aspartyl glucosaminidase (561),ßglucuronidase deficiency (VII)
(537),Fucosidosis (562),Gaucher disease
(541),Glucose storage disease
(548),Hunter syndrome (II) (533),Hurler
syndrome (IH) (531),I-cell disease
(546),Krabbe disease (globoid
leukodystrophy) (544),Lesch-Nyhan
(HGPRT deficiency) (522),Mannosidosis
(563),Maroteaux-Lamy (VI)
(536),Metachromatic leukodystrophy
(MLD) (542),Mucolipidoses, not
otherwise specified (540),Morquio (IV)
(535),Mucopolysaccharidosis (V)
(538),Mucopolysaccharidosis, not
otherwise specified (530),Niemann-Pick
disease (545),Neuronal ceroid
lipofuscinosis (Batten disease)
(523),Other inherited metabolic disorder
(529),Osteopetrosis (malignant infantile
osteopetrosis) (521),Polysaccharide
hydrolase abnormality, not otherwise
specified (560),Sanfilippo (III)
(534),Scheie syndrome (IS)
(532),Inherited metabolic disorder, not
otherwise specified (520),Wolman
disease (547)
Change/Clarification of Response Options

Specify inherited disorders of
metabolism classification

Specify other inherited metabolic disorder: open text

Specify other inherited metabolic
disorder:

open text

Loes composite score

Loes composite score

__ __ Adrenoleukodystrophy (ALD) only

Specify histiocytic disorder
classification

Histiocytic disorder, not otherwise specified
(570),Langerhans cell histiocytosis (histiocytosis-X)
(572),Hemophagocytic lymphohistiocytosis (HLH)
(571),Hemophagocytosis (reactive or viral
associated) (573),Malignant histiocytosis
(574),Other histiocytic disorder (579)

Specify other histiocytic disorder:
open text
Did the recipient have an active or
recent infection with a viral
pathogen within 60 days of HCT?
Hemophagocytic lymphohistiocytosis
(HLH) only
No,Yes

no

Specify inherited disorders of metabolism
classification

yes

no

yes

no

yes

no

Specify histiocytic disorder classification

__ __ Adrenoleukodystrophy (ALD) only
Histiocytic disorder, not otherwise
specified (570),Langerhans cell
histiocytosis (histiocytosis-X)
(572),Hemophagocytic
lymphohistiocytosis (HLH)
(571),Hemophagocytosis (reactive or
viral associated) (573),Malignant
histiocytosis (574),Other histiocytic
disorder (579)

yes

no

Specify other histiocytic disorder:

open text

no

Did the recipient have an active or recent
infection with a viral pathogen within 60
days of HCT? Hemophagocytic
lymphohistiocytosis (HLH) only

No,Yes

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Rationale for Information Collection Update

Hereditary diffuse leukoencephalopathy with
spheroids, Adrenoleukodystrophy (ALD)
(543),Aspartyl glucosaminidase (561),ßglucuronidase deficiency (VII) (537),Fucosidosis
(562),Gaucher disease (541),Glucose storage
disease (548),Hunter syndrome (II) (533),Hurler
syndrome (IH) (531),I-cell disease (546),Krabbe
disease (globoid leukodystrophy) (544),LeschNyhan (HGPRT deficiency) (522),Mannosidosis
(563),Maroteaux-Lamy (VI) (536),Metachromatic
leukodystrophy (MLD) (542),Mucolipidoses, not
otherwise specified (540),Morquio (IV)
(535),Mucopolysaccharidosis (V)
(538),Mucopolysaccharidosis, not otherwise
specified (530),Niemann-Pick disease
(545),Neuronal ceroid lipofuscinosis (Batten
disease) (523),Other inherited metabolic disorder
(529),Osteopetrosis (malignant infantile
osteopetrosis) (521),Polysaccharide hydrolase
abnormality, not otherwise specified
(560),Sanfilippo (III) (534),Scheie syndrome (IS)
(532),Inherited metabolic disorder, not otherwise Be consistent with current clinical landscape, improve
specified (520),Wolman disease (547)
transplant outcome data

yes

yes

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Page 48 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Disease
Classification
Disease
Classification

Disease
Classification
Disease
Classification
Disease
Classification
Disease
Classification

Histiocytic
Disorders
Histiocytic
Disorders

Autoimmune
Diseases
Autoimmune
Diseases
Autoimmune
Diseases
Autoimmune
Diseases

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

Current Information Collection Data
Element Response Option(s)
Information Collection update:
Adenovirus,BK Virus,Chikaugunya
Virus,Cytomegalovirus
(CMV),Coronavirus,Dengue Virus,EpsteinBarr Virus (EBV),Enterovirus D68 (EVD68),Enterovirus (ECHO,
Coxsackie),Enterovirus, NOS,Enterovirus
(polio),Hepatitis A Virus,Hepatitis B
Virus,Hepatitis C Virus,Hepatitis
E,Human herpesvirus 6 (HHV-6),Human
Immunodeficiency Virus 1 or 2,Human
metapneumovirus,Human
Papillomavirus (HPV),Herpes Simplex
Virus (HSV),Human T-lymphotropic Virus
1 or 2,Influenza A Virus,Influenza B
Virus,Influenza, NOS,JC Virus
(Progressive Multifocal
Leukoencephalopathy (PML)),Measles
Virus (Rubeola),Mumps
Virus,Norovirus,Human Parainfluenza
Virus (all species),Rhinovirus (all
species),Rotavirus (all
species),Respiratory Syncytial Virus
(RSV),Rubella Virus,Varicella Virus,West
Nile Virus (WNV)

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Adenovirus,BK Virus,Chikaugunya
Virus,Cytomegalovirus (CMV),Coronavirus,Dengue
Virus,Epstein-Barr Virus (EBV),Enterovirus D68 (EVD68),Enterovirus (ECHO, Coxsackie),Enterovirus,
NOS,Enterovirus (polio),Hepatitis A Virus,Hepatitis
B Virus,Hepatitis C Virus,Hepatitis E,Human
herpesvirus 6 (HHV-6),Human Immunodeficiency
Virus 1 or 2,Human metapneumovirus,Human
Papillomavirus (HPV),Herpes Simplex Virus
(HSV),Human T-lymphotropic Virus 1 or
2,Influenza A Virus,Influenza B Virus,Influenza,
NOS,JC Virus (Progressive Multifocal
Leukoencephalopathy (PML)),Measles Virus
(Rubeola),Mumps Virus,Norovirus,Human
Parainfluenza Virus (all species),Rhinovirus (all
species),Rotavirus (all species),Respiratory
Specify viral pathogen (check all that Syncytial Virus (RSV),Rubella Virus,Varicella
apply)
Virus,West Nile Virus (WNV)
Has the recipient ever been infected
with PCP / PJP?
No,Yes

yes

no

yes

no

Specify viral pathogen (check all that
apply)
Has the recipient ever been infected with
PCP / PJP?

yes

no

Antiphospholipid syndrome,Behcet
syndrome,Churg-Strauss,Classical
polyarteritis nodosa,Crohn's
disease,Diabetes mellitus type I,Evan
syndrome,Giant cell arteritis,Hemolytic
anemia,Idiopathic thrombocytopenic
purpura (ITP),Juvenile idiopathic arthritis
(JIA): oligoarticular,Juvenile idiopathic
arthritis (JIA): other,Juvenile idiopathic
arthritis (JIA): polyarticular,Juvenile
idiopathic arthritis (JIA): systemic (Stills
disease),Microscopic polyarteritis
nodosa,Multiple sclerosis,Myasthenia
gravis,Other autoimmune
disorder,Overlap necrotizing
arteritis,Other arthritis,Other
autoimmune bowel disorder,Other
autoimmune cytopenia,Other
autoimmune neurological
disorder,Other connective tissue
disease,Other vasculitis,Psoriatic arthritis
/ psoriasis,Polymyositis /
dermatomyositis,Rheumatoid
arthritis,Sjogren syndrome,Systemic
lupus erythematosis (SLE),Systemic
sclerosis,Takayasu,Ulcerative
Specify autoimmune disease classification colitis,Wegener granulomatosis

yes

no

Specify other autoimmune cytopenia:

yes

no

Specify other autoimmune bowel disorder: open text

Specify autoimmune disease
classification
Specify other autoimmune
cytopenia:
Specify other autoimmune bowel
disorder:

yes

no

Specify other autoimmune disease:

Specify other autoimmune disease:

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

No,Yes

open text

open text

Rationale for Information Collection Update

Antiphospholipid syndrome,Behcet
syndrome,Churg-Strauss,Classical polyarteritis
nodosa,Crohn's disease,Diabetes mellitus type
I,Evan syndrome,Giant cell arteritis,Hemolytic
anemia,Idiopathic thrombocytopenic purpura
(ITP),Juvenile idiopathic arthritis (JIA):
oligoarticular,Juvenile idiopathic arthritis (JIA):
other,Juvenile idiopathic arthritis (JIA):
polyarticular,Juvenile idiopathic arthritis (JIA):
systemic (Stills disease),Microscopic polyarteritis
nodosa,Multiple sclerosis,Myasthenia gravis,Other
autoimmune disorder,Overlap necrotizing
arteritis,Other arthritis,Other autoimmune bowel
disorder,Other autoimmune cytopenia,Other
autoimmune neurological disorder,Other
connective tissue disease,Other vasculitis,Psoriatic
arthritis / psoriasis,Polymyositis /
dermatomyositis,Rheumatoid arthritis,Sjogren
syndrome,Systemic lupus erythematosis
(SLE),Systemic sclerosis,Takayasu,Ulcerative
colitis,Wegener granulomatosis
open text
open text
open text

Page 49 of 50

Information
Collection
Information
Domain
Collection Domain Additional Sub
Sub-Type
Domain

Disease
Classification

Disease
Classification

Disease
Classification
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data
Pre-Transplant
Essential Data

Tolerance
Induction
Associated with
Solid Organ
Transplant
Tolerance
Induction
Associated with
Solid Organ
Transplant
Tolerance
Induction
Associated with
Solid Organ
Transplant

Response required if
Additional Sub Domain Information Collection may be
applies
requested multiple times

Current Information Collection Data
Element (if applicable)

yes

no

Specify solid organ transplanted (check all
that apply)
Kidney,Liver,Other organ,Pancreas

Specify solid organ transplanted
(check all that apply)

Kidney,Liver,Other organ,Pancreas

yes

no

Specify other organ:

open text

Specify other organ:

open text

yes

no

Specify other disease:

open text

open text

yes

First Name (person completing form):

open text

Specify other disease:
First Name (person completing
form):

yes

Last Name:

open text

Last Name:

open text

yes

E-mail address:

open text

E-mail address:

open text

yes

Date:

YYYY/MM/DD

Date:

YYYY/MM/DD

SCTOD Information Collection_to HRSA 2022-03-29.xlsx - Pre-Transplant Information Coll

Current Information Collection Data
Element Response Option(s)
Information Collection update:

Proposed Information Collection Proposed Information Collection Data
Data Element (if applicable)
Element Response Option(s)

Rationale for Information Collection Update

open text

Page 50 of 50