Form 1 Baseline Pre-TED (Transplant Essential Data)

Stem Cell Therapeutic Outcomes Database

FormBaselinePreTED

Baseline Pre-TED (Transplant Essential Data)

OMB: 0915-0310

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Pre-Transplant Essential Data

CIBMTR Use Only
Sequence Number:
Date Received:

(Request for OMB approval will be submitted when form is complete)
OMB No: 0915-0310
Expiration Date: 1/31/2020
Public Burden Statement: An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays a currently valid
OMB control number. The OMB control number for this project is 0915-0310. Public
reporting burden for this collection of information is estimated to average 0.85 hours per
response, including the time for reviewing instructions, searching existing data sources,
and completing and reviewing the collection of information. Send comments regarding
this burden estimate or any other aspect of this collection of information, including
suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers
Lane, Room 10-33, Rockville, Maryland, 20857.
Expiration date: 1/31/2020

Center Identification
CIBMTR Center Number: ___ ___ ___ ___ ___ 	
EBMT Code (CIC): ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
Recipient Identification
CIBMTR Research ID (CRID): ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ 	
Event date: __ __ __ __ / __ __ / __ __
	
YYYY
MM
DD	

CIBMTR Form 2400 revision 6 (page 1 of 17). Form released November, 2018. Last Updated April, 2019.
Copyright (c) 2018 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___	

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Recipient Data
1.	
	

Date of birth: __ __ __ __ / __ __ / __ __
YYYY
MM
DD	

2.	Sex:	
☐ Male	

☐ Female	

3.	Ethnicity:	
☐ Hispanic or Latino	
	
4.	 Race: (check all that apply)

☐ Not Hispanic or Latino	

☐ White		
	☐ Black or African American	
	☐ Asian	
	☐ American Indian or Alaska Native
	☐ Native Hawaiian or Other Pacific
	

		Islander	

	☐ Not reported	
	☐ Unknown - Go to question 6	
	

5.	

☐ Not applicable (not a resident of the USA)	

Race detail: (check all that apply)

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

CIBMTR Form 2400 revision 6 (page 2 of 17). Form released November, 2018. Last Updated April, 2019.
Copyright (c) 2018 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

☐ Unknown	

CIBMTR Center Number: ___ ___ ___ ___ ___	
6.	

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Country of primary residence:

	☐ Afghanistan
	☐ Aland Islands
	☐ Albania
	☐ Algeria
	☐ American Samoa
	☐ Andorra
	☐ Angola
	☐ Anguilla
	☐ Antarctica
	☐ Antigua and Barbuda
	☐ Argentina
	☐ Armenia
	☐ Aruba
	☐ Australia
	☐ Austria
	☐ Azerbaijan
	☐ Bahamas
	☐ Bahrain
	☐ Bangladesh
	☐ Barbados
	☐ Belarus
	☐ Belgium
	☐ Belize
	☐ Benin
	☐ Bermuda
	☐ Bhutan
	☐ Bolivia
	☐ Bonaire, Sint Eustatius and Saba
	☐ Bosnia and Herzegovina
	☐ Botswana
	☐ Bouvet Island
	☐ Brazil - go to question 7
	☐ British Indian Ocean Territory
	☐ British Virgin Islands
	☐ Brunei Darussalam
	☐ Bulgaria
	☐ Burkina Faso
	☐ Burundi
	☐ Cambodia
	☐ Cameroon
	☐ Canada - go to question 8
	☐ Cape Verde
	☐ Cayman Islands
	☐ Central African Republic

☐ Chad
☐ Chile
☐ China
☐ Christmas Island
☐ Cocos (Keeling) Islands
☐ Colombia
☐ Comoros
☐ Congo, Democratic Republic of the
☐ Congo, Republic of the
☐ Cook Islands
☐ Costa Rica
☐ Cote d’Ivoire
☐ Croatia
☐ Cuba
☐ Curacao
☐ Cyprus
☐ Czech Republic
☐ Denmark
☐ Djibouti
☐ Dominica
☐ Dominican Republic
☐ Ecuador
☐ Egypt
☐ El Salvador
☐ Equatorial Guinea
☐ Eritrea
☐ Estonia
☐ Ethiopia
☐ Falkland Islands
☐ Faroe Islands
☐ Fiji
☐ Finland
☐ France
☐ French Guiana
☐ French Polynesia
☐ French Southern Territories
☐ Gabon
☐ Gambia
☐ Georgia
☐ Germany
☐ Ghana
☐ Gibraltar
☐ Greece
☐ Greenland

☐ Grenada
☐ Guadeloupe
☐ Guam
☐ Guatemala
☐ Guernsey
☐ Guinea
☐ Guinea-Bissau
☐ Guyana
☐ Haiti
☐ Heard Island and McDonald Islands
☐ Holy See
☐ Honduras
☐ Hong Kong
☐ Hungary
☐ Iceland
☐ India
☐ Indonesia
☐ Iran
☐ Iraq
☐ Ireland
☐ Isle of Man
☐ Israel
☐ Italy
☐ Jamaica
☐ Japan
☐ Jersey
☐ Jordan
☐ Kazakhstan
☐ Kenya
☐ Kiribati
☐ Kuwait
☐ Kyrgyzstan
☐ Laos
☐ Latvia
☐ Lebanon
☐ Lesotho
☐ Liberia
☐ Libya
☐ Liechtenstein
☐ Lithuania
☐ Luxembourg
☐ Macau
☐ Macedonia
☐ Madagascar

CIBMTR Form 2400 revision 6 (page 3 of 17). Form released November, 2018. Last Updated April, 2019.
Copyright (c) 2018 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___	

	

	☐ Malawi
	☐ Malaysia
	☐ Maldives
	☐ Mali
	☐ Malta
	☐ Marshall Islands
	☐ Martinique
	☐ Mauritania
	☐ Mauritius
	☐ Mayotte
	☐ Mexico
	☐ Micronesia
	☐ Moldova
	☐ Monaco
	☐ Mongolia
	☐ Montenegro
	☐ Montserrat
	☐ Morocco
	☐ Mozambique
	☐ Myanmar
	☐ Namibia
	☐ Nauru
	☐ Nepal
	☐ Netherlands
	☐ Netherlands Antilles
	☐ New Caledonia
	☐ New Zealand
	☐ Nicaragua
	☐ Niger
	☐ Nigeria
	☐ Niue
	☐ Norfolk Island
	☐ North Korea
	☐ Northern Mariana Islands
	☐ Norway
	☐ Oman
	☐ Pakistan
	☐ Palau
	☐ Palestine, State of
☐ Panama

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

☐ Papua New Guinea
☐ Paraguay
☐ Peru
☐ Philippines
☐ Pitcairn Islands
☐ Poland
☐ Portugal
☐ Puerto Rico
☐ Qatar
☐ Reunion
☐ Romania
☐ Russia
☐ Rwanda
☐ Saint Barthelemy
☐ Saint Helena
☐ Saint Kitts and Nevis
☐ Saint Lucia
☐ Saint Martin, French
☐ Saint Pierre and Miquelon
☐ Saint Vincent and the Grenadines
☐ Samoa
☐ San Marino
☐ Sao Tome and Principe
☐ Saudi Arabia
☐ Senegal
☐ Serbia
☐ Seychelles
☐ Sierra Leone
☐ Singapore
☐ Sint Maarten, Dutch
☐ Slovak Republic
☐ Slovenia
☐ Solomon Islands
☐ Somalia
☐ South Africa
☐ South Georgia and the South Sandwich
☐ Islands
☐ South Korea
☐ South Sudan
☐ Spain

☐ Sri Lanka
☐ Sudan
☐ Suriname
☐ Svalbard and Jan Mayen
☐ Swaziland
☐ Sweden
☐ Switzerland
☐ Syria
☐ Taiwan
☐ Tajikistan
☐ Tanzania
☐ Thailand
☐ Timor-Leste
☐ Togo
☐ Tokelau
☐ Tonga
☐ Trinidad and Tobago
☐ Tunisia
☐ Turkey
☐ Turkmenistan
☐ Turks and Caicos Islands
☐ Tuvalu
☐ Uganda
☐ Ukraine
☐ United Arab Emirates
☐ United Kingdom (England, Wales, Scotland, 		
	

Northern Ireland)

☐ United States - go to question 9
☐ United States Minor Outlying Islands
☐ United States Virgin Islands
☐ Uruguay
☐ Uzbekistan
☐ Vanuatu
☐ Venezuela
☐ Vietnam
☐ Wallis and Futuna Islands
☐ Western Sahara
☐ Yemen
☐ Zambia
☐ Zimbabwe

CIBMTR Form 2400 revision 6 (page 4 of 17). Form released November, 2018. Last Updated April, 2019.
Copyright (c) 2018 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___	

7.	

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

State of residence of recipient: (for residents of Brazil)

	

☐ Acre
☐ Alagoas
☐ Amapá
☐ Amazonas
☐ Bahia
☐ Ceará
☐ Distrito Federal
☐ Espírito Santo
☐ Goiás

8.	

Province or territory of residence of recipient: (for residents of Canada)

	
	
	
	
	
	
	
	

☐ Maranhão
☐ Mato Grosso
☐ Mato Grosso do Sul
☐ Minas Gerais
☐ Pará
☐ Paraná
☐ Paraíba
☐ Pernambuco
☐ Piauí

	Provinces:

	

☐ Alberta
☐ British Columbia
☐ Quebec
☐ Manitoba
☐ New Brunswick
☐ Newfoundland and Labrador

9.	

State of residence of recipient: (for residents of USA)

	
	
	
	
	

	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	

☐ Alabama
☐ Alaska
☐ Arizona
☐ Arkansas
☐ California
☐ Colorado
☐ Connecticut
☐ Delaware
☐ District of Columbia
☐ Florida
☐ Georgia
☐ Hawaii
☐ Idaho
☐ Illinois
☐ Indiana
☐ Iowa
☐ Kansas

☐ Nova Scotia
☐ Ontario
☐ Prince Edward Island
☐ Quebec
☐ Saskatchewan

☐ Kentucky
☐ Louisiana
☐ Maine
☐ Maryland
☐ Massachusetts
☐ Michigan
☐ Minnesota
☐ Mississippi
☐ Missouri
☐ Montana
☐ Nebraska
☐ Nevada
☐ New Hampshire
☐ New Jersey
☐ New Mexico
☐ New York
☐ North Carolina

☐ Rio de Janeiro
☐ Rio Grande do Norte
☐ Rio Grande do Sul
☐ Rondônia
☐ Roraima
☐ Santa Catarina
☐ São Paulo
☐ Sergipe
☐ Tocantins

Territories:

☐ Northwest Territories
☐ Nunavut
☐ Yukon

☐ North Dakota
☐ Ohio
☐ Oklahoma
☐ Oregon
☐ Pennsylvania
☐ Rhode Island
☐ South Carolina
☐ South Dakota
☐ Tennessee
☐ Texas
☐ Utah
☐ Vermont
☐ Virginia
☐ Washington
☐ West Virginia
☐ Wisconsin
☐ Wyoming

10.	 NMDP Recipient ID (RID): __ __ __ __ __ __ __
11.	

Zip or postal code for place of recipient’s residence (USA recipients only):	 ___ ___ ___ ___ ___ - ___ ___ ___ ___ (last 4 digits optional)

12.	 Specify blood type: (recipient) (For allogeneic HCTs only) 	

CIBMTR Form 2400 revision 6 (page 5 of 17). Form released November, 2018. Last Updated April, 2019.
Copyright (c) 2018 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

☐ A 	 ☐ B 	 ☐ AB 	 ☐ O

CIBMTR Center Number: ___ ___ ___ ___ ___	

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

☐ Positive 	 ☐ Negative

13.	 Specify Rh factor: (recipient) (For allogeneic HCTs only) 		

14.	 Has the recipient signed an IRB / ethics committee (or similar body) approved consent form for submitting research data to the NMDP / 	
	CIBMTR?

	☐ Yes (recipient consented)
	☐ No (recipient declined)
	☐ Not approached

15.	 Did the recipient give permission to be directly contacted by CIBMTR for future 		
	research?	

	☐ Yes (recipient provided permission)	
	
☐ No (recipient declined)

16.	 Date form was signed:
	
	

__ __ __ __ / __ __ / __ __
YYYY
MM
DD

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

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

18.	
	

Date form was signed: __ __ __ __ / __ __ / __ __
YYYY
MM
DD

19.	
	

Did the recipient submit a research sample to the NMDP/CIBMTR repository?
(Related donors only)

	☐ Yes	
	
☐ No

20.	

Research sample recipient ID:

	

___ ___ ___ ___ ___ ___ ___ ___ ___ ___

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

	☐ Yes
	☐ No

22.	
	
	
	
	
	
	

Study Sponsor:

☐ BMT-CTN - Go to question 24
☐ RCI-BMT - Go to question 24
☐ PIDTC - Go to question 24
☐ USIDNET - Go to question 25
☐ COG - Go to question 25
☐ Other sponsor - Go to question 23
23.	
	

Specify other sponsor:________________________________
- Go to question 25

24.	

Study ID Number:___________________________________

25.	

Subject ID:_________________________________________

Copy questions 22-25 to report participation in more than one study.	

CIBMTR Form 2400 revision 6 (page 6 of 17). Form released November, 2018. Last Updated April, 2019.
Copyright (c) 2018 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___	

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Hematopoietic Cellular Transplant (HCT) and Cellular Therapy
26.	 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)
	
	

☐ Yes
☐ No

27.	

Specify subsequent HCT planned:	

29.	

Specify the number of prior HCTs: ___ ___

30.	

Were all prior HCTs reported to the CIBMTR? 	

☐ Autologous 	 ☐ Allogeneic

28.	 Has the recipient ever had a prior HCT?
	
	

☐ Yes
☐ No

☐ Yes 	 ☐ No 	 ☐ Unknown

Copy and complete questions 31-39 to report all prior HCTs that have not yet been
reported to the CIBMTR:

	

31.	
	

Date of the prior HCT: __ __ __ __ / __ __ / __ __ ☐ Date estimated
YYYY
MM
DD

32.	

Was the prior HCT performed at a different institution?

	
	

☐ Yes 	
☐ No

Specify the institution that performed the last HCT:
33.	Name:____________________________________________
	City: ______________________________________________
	State: _____________________________________________
	Country:___________________________________________

34.	

What was the HPC source for the prior HCT?

	

☐ Autologous 	 ☐ Allogeneic, unrelated donor 	 ☐ Allogeneic, related donor

35.	

Reason for current HCT:

	
	
	
	
	
	
	

☐ Graft failure / insufficient hematopoietic recovery - Go to question 36
☐ Persistent primary disease - Go to question 40
☐ Recurrent primary disease - Go to question 37
☐ Planned subsequent HCT, per protocol - Go to question 40
☐ New malignancy (including PTLD and EBV lymphoma) - Go to question 38
☐ Insufficient chimerism - Go to question 40
☐ Other - Go to question 39
36.	
	
	

Date of graft failure / rejection: __ __ __ __ / __ __ / __ __
YYYY
MM
DD
- Go to question 40

37.	
	
	

Date of relapse: : __ __ __ __ / __ __ / __ __
YYYY
MM
DD
- Go to question 40

38.	
	
	

Date of secondary malignancy: __ __ __ __ / __ __ / __ __
YYYY
MM
DD
- Go to question 40

39.	 Specify other reason:_________________________________

CIBMTR Form 2400 revision 6 (page 7 of 17). Form released November, 2018. Last Updated April, 2019.
Copyright (c) 2018 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___	

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

40.	 Has the recipient ever had a prior cellular therapy? (do not include DLIs)
	
	
	

☐ Yes
☐ No
☐ Unknown

41.	 Were all prior cellular therapies reported to the CIBMTR?

☐ Yes 	
☐ No
☐ Unknown

	
	
	

Copy and complete questions 43-46 to report all prior cellular therapies that have
not yet been reported to the CIBMTR:
42.	
	

Date of the prior cellular therapy: __ __ __ __ / __ __ / __ __
YYYY
MM
DD

43.	

Was the cellular therapy performed at a different institution?

	
	

☐ Yes 	
☐ No

44.	

Name:____________________________________________

	City: ______________________________________________
	State: _____________________________________________
	Country:___________________________________________

45.	
	

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

☐ Autologous 	 ☐ Allogeneic, unrelated donor 	 ☐ Allogeneic, related donor

Donor Information
46.	 Multiple donors?

	☐ Yes		
	
☐ No	

47.	 Specify number of donors: ___ ___

To report more than one donor, copy questions 48-83 and complete for each donor.

☐ Autologous 	☐ Allogeneic, related	

48.	 Specify donor:	

☐ Allogeneic, unrelated

49.	 Specify product type: (check all that apply)

	☐ Bone marrow	
	☐ PBSC	
	☐ Single cord blood unit	
	☐ Other product	
		

50. 	 Specify other product type:______________________________________________

51.	 Is the product genetically modified? If autologous, go to question 58. If allogeneic related, go to question 52. If allogeneic unrelated, 	
	
go to question 56.

	☐ Yes	

☐ No

52.	 Specify the related donor type:
	
	
	
	

☐ Syngeneic (monozygotic twin) - Go to question 55
☐ HLA-identical sibling (may include non-monozygotic twin) - Go to question 55
☐ HLA-matched other relative (does NOT include a haplo-identical donor) - Go to question 53
☐ HLA-mismatched relative - Go to question 53

CIBMTR Form 2400 revision 6 (page 8 of 17). Form released November, 2018. Last Updated April, 2019.
Copyright (c) 2018 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___	

53.	
	
	
	
	
	
	
	
	
	
	
	
	

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Specify related relationship

☐ Recipient’s mother
☐ Recipient’s father
☐ Recipient’s child
☐ Maternal aunt
☐ Maternal uncle
☐ Maternal cousin
☐ Paternal aunt
☐ Paternal uncle
☐ Paternal cousin
☐ Grandparent
☐ Grandchild
☐ Other biological relative

54.	 Specify other biological relative:
	

55.	
	

_____________________________

Degree of mismatch:

☐ HLA-mismatched 1 allele - Go to question 57

	
☐ HLA-mismatched ≥2 alleles (does include haplo-identical donor)
		
- Go to question 57

☐ HLA matched unrelated	

☐ HLA mismatched unrelated

56.	

Specify unrelated donor type	

57.	

Did NMDP/Be the Match facilitate the procurement, collections, or transportation of the product?

58.	

Was this donor used for any prior HCTs? (for this recipient) If auto, go to question 80 	☐ Yes	

59.	

NMDP unrelated cord blood unit ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ - Go to question 63

60.	

NMDP unrelated donor ID: ___ ___ ___ ___ — ___ ___ ___ ___ — ___ - Go to question 63

61.	
	
	

Non-NMDP unrelated donor ID: (not applicable for related donors)

62.	

Non-NMDP cord blood unit ID: (include related and autologous CBUs)

	

___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ - Go to question 63

63.	

Global Registration Identifier for Donors (GRID):

	
	
	
	
	

__ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ (optional)
NMDP cord blood unit, go to question 75
NMDP donor, go to question 75
Non-NMDP unrelated donor, go to question 66
Non-NMDP cord blood unit, go to question 64

64.	

Is the CBU ID also the ISBT DIN number?

	☐ Yes	

☐ No

☐ No

___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ - Go to question 63

	☐ Yes
	☐ No
	☐ Unknown

65.	 Specify the ISBT DIN number:___________________________________________

CIBMTR Form 2400 revision 6 (page 9 of 17). Form released November, 2018. Last Updated April, 2019.
Copyright (c) 2018 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___	
66.	

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Registry or UCB Bank ID: ___ ___ ___ ___ - If ‘Other registry’ go to 67, otherwise go to question 68
67.	 Specify other Registry or UCB Bank:______________________________________

68.	

Date of birth: (donor / infant)

	☐ Known

	☐ Unknown

69.	
	

Date of birth: (donor / infant) __ __ __ __ / __ __ / __ __ - Go to question 72
YYYY
MM
DD

70.	

Age: (donor / infant)

	
	

☐ Known 	
☐ Unknown

71.	 Age: (donor / infant) ___ ___
	
	

☐ Months (use only if less than 1 year old)
☐ Years

72.	 Sex: (donor / infant)	☐ Male	

☐ Female

☐ A 	 ☐ B 	 ☐ AB 	 ☐ O

73.	 Specify blood type: (donor) (non-NMDP allogeneic donors only) 	
74.	 Specify Rh factor: (donor) (non-NMDP allogeneic donors only) 		

☐ Positive 	 ☐ Negative

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

	☐ Reactive	

☐ Non-reactive	

☐ Indeterminant	

☐ Not done	 ☐ Not applicable (cord blood unit)

76.	 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)

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

77.	
	

Date form was signed: __ __ __ __ / __ __ / __ __
YYYY
MM
DD

78.	
	

Did the donor submit a research sample to the NMDP/CIBMTR repository? (Related 	
donors only)	

	
	

☐ Yes
☐ No

79.	 Research sample donor ID:
	

___ ___ ___ ___ ___ ___ ___ ___ ___ ___

A series of collections should be considered a single product when they are all from the same donor and use the same collection method
and technique (and mobilization, if applicable), even if the collections are performed on different days.
80.	 Specify number of products infused from this donor: ___ ___
81.	 Specify the number of these products intended to achieve hematopoietic engraftment: ___ ___
Questions 82-83 are for autologous HCT recipients only. If other than autologous skip to question 84.

CIBMTR Form 2400 revision 6 (page 10 of 17). Form released November, 2018. Last Updated April, 2019.
Copyright (c) 2018 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___	

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

82.	 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

83.	

Specify other agent:_____________________________________________________

To report more than one donor, copy questions 48-83 and complete for each donor.
Clinical Status of Recipient Prior to the Preparative Regimen (Conditioning)
84.	 What scale was used to determine the recipient’s functional status?
	
	

☐ Karnofsky (recipient age ≥ 16 years)	

Performance score prior to the preparative regimen:
85. 	 Karnofsky Scale (recipient age ≥ 16 years):

	

	
	
	
	
	
	
	
	
	
	
	

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

☐ Lansky (recipient age ≥ 1 year and < 16 years)
86.	
	
	
	
	
	

Lansky Scale (recipient age ≥ 1 year and < 16 years):

☐ 100 Fully active
☐ 90 Minor restriction in physically strenuous play	
☐ 80 Restricted in strenuous play, tires more easily, otherwise active
☐ 70 Both greater restrictions of, and less time spent in, active play
☐ 60 Ambulatory up to 50% of time, limited active play with assistance/supervision
☐ 50 Considerable assistance required for any active play; fully able to 	engage in 	

	
		
	
	
	
	
87.	 Recipient CMV-antibodies (IgG or Total):	

	☐ Reactive	

☐ Non-reactive	

quiet play

☐ 40 Able to initiate quiet activities
☐ 30 Needs considerable assistance for quiet activity
☐ 20 Limited to very passive activity initiated by others (e.g., TV)	
☐ 10 Completely disabled, not even passive play

☐ Indeterminant	

☐ Not done	

CIBMTR Form 2400 revision 6 (page 11 of 17). Form released November, 2018. Last Updated April, 2019.
Copyright (c) 2018 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___	

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Co-morbid Conditions

☐ Yes	
☐ Yes	

88. 	 Is there a history of mechanical ventilation?	
89. 	 Is there a history of invasive fungal infection?	

☐ No
☐ No

90.	 Glomerular filtration rate (GFR) before start of preparative regimen

	☐ Known	
	
☐ Unknown

91.	

Glomerular filtration rate (GFR): __ __ __ mL/min/1.732

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

	☐ Yes	

☐ No

93.	 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.

	☐ Yes	
	
☐ No

94.	

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

	
☐ 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

	
☐ Hepatic, moderate/severe – Liver cirrhosis, bilirubin > 1.5 × upper limit of normal, or AST/ALT > 2.5 × 	
		 upper limit of normal
	
☐ Infection – Includes a documented infection, fever of unknown origin, or pulmonary nodules
		 suspicious for fungal pneumonia or a positive PPD test requiring prophylaxis against
	
	 tuberculosis. Patients must have started antimicrobial treatment before Day 0 with continuation of 	
	
	 antimicrobial treatment after day 0
	

☐ Inflammatory bowel disease – Any history of Crohn’s disease or ulcerative colitis requiring treatment
☐ Obesity – Patients older than 18 years with a body mass index (BMI) > 35 kg/m prior to the start of 	

	
		

2

conditioning or a BMI of the 95th percentile of higher for patients aged 18 years or younger

	
☐ Peptic ulcer – Any history of peptic (gastric or duodenal) ulcer confirmed by endoscopy or
		 radiologic diagnosis requiring treatment

	
☐ Psychiatric disturbance – Presence of any mood (e.g., depression), anxiety, or other psychiatric 	
		 disorder (e.g. bipolar disorder or schizophrenia) requiring continuous treatment in the last 4 weeks
	
☐ Pulmonary, moderate – Corrected diffusion capacity of carbon monoxide and/or FEV1 of 66-80% or
		 dyspnea on slight activity attributed to pulmonary disease at transplant

	
☐ Pulmonary, severe – Corrected diffusion capacity of carbon monoxide and/or FEV1 of ≤ 65% or 	
		 dyspnea at rest attributed to pulmonary disease or the need for intermittent or continuous oxygen 	
		 during the 4 weeks prior to 	transplant
	
☐ Renal, moderate / severe – Serum creatinine > 2 mg/dL or > 177 μmol/L; on dialysis at during the 4 	
		 weeks prior to transplant; OR prior renal transplantation - Go to question 95
	
☐ Rheumatologic – Any history of a rheumatologic disease (e.g., systemic lupus erythematosis, 		
		 rheumatoid arthritis, polymyositis, mixed connective tissue disease, or polymyalgia rheumatica, 	
		 etc.) requiring treatment. (Do NOT include degenerative joint disease, osteoarthritis)
	
☐ Prior malignancy, specify – Treated at any time point in the patient’s past history, other than the 	
		 primary disease for which this HCT is being performed	- go to question 97

CIBMTR Form 2400 revision 6 (page 12 of 17). Form released November, 2018. Last Updated April, 2019.
Copyright (c) 2018 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___	

95.	
	
96.	
	
	

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

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

☐ Yes	

☐ No	

☐ Unknown

Specify prior malignancy (check all that apply)

☐ 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 (includes acute or chronic 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 hematologic malignancy - Go to question 97
☐ Other solid tumor, prior - Go to question 98
97.	

Specify other prior hematologic malignancy:___________________

98.	

Specify other solid tumor:_________________________________

Use results within 4 weeks prior to the start of the preparative regimen, report results from the test performed closest to the start date.
Biomarkers according to the augmented HCT comorbidity index Source: Biol Blood Marrow Transplant. 2015 Aug; 21(8): 1418–1424.
99.	 Serum ferritin: (with 4 weeks prior to the start of the preparative regimen, use result closest to the start date)

	☐ Known	
	
☐ Unknown

100.	 ___ ___ ___ ___ ___ 	ng/mL (μg/L)
101.	 Date sample collected: __ __ __ __ / __ __ / __ __
	
YYYY
MM
DD
102.	 Upper limit of normal for your institution: ___ ___ ___ ___ ___ ng/mL (μg/L)

103.	 Serum albumin: (with 4 weeks prior to the start of the preparative regimen, use result closest to the start date)

	☐ Known	
	
☐ Unknown

104.	 ___ ___ ● ___ 	

☐ g/dL	

☐ g/L

105.	 Date sample collected: __ __ __ __ / __ __ / __ __
	
YYYY
MM
DD

CIBMTR Form 2400 revision 6 (page 13 of 17). Form released November, 2018. Last Updated April, 2019.
Copyright (c) 2018 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___	

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

106.	 Platelets: (with 4 weeks prior to the start of the preparative regimen, use result closest to the start date)

	☐ Known	
	
☐ Unknown

107.	 ___ ___ ___ ___ ___ ___ ___	

☐ x 10 /L (x 10 /mm )	 ☐ x 10 /L
9

3

3

6

108.	 Were platelets transfused ≤ 7 days before date of test?

	☐ Yes	

☐ No	

☐ Unknown

109.	 Did the recipient have a prior solid organ transplant?

	☐ Known	
	
☐ Unknown

110.	 Specify organ:

	☐ Bowel
	☐ Heart
	☐ Kidney(s)
	☐ Liver
	☐ Lung(s)
	☐ Pancreas
	☐ Other organ

111.	 Specify other organ:________________________

112.	 Year of prior solid organ transplant: ___ ___ ___ ___
Copy and complete questions 110-112 for each prior solid organ transplant

Pre-HCT Preparative Regimen (Conditioning)
113. 	Height at initiation of pre-HCT preparative regimen: ___ ___ ___ 	 ☐ inches	
114. 	Actual weight at initiation of pre-HCT preparative regimen: ___ ___ ___ ● ___	

☐ centimeters
☐ pounds	 ☐ kilograms

115. 	Was a pre-HCT preparative regimen prescribed?

	☐ Yes	
	
☐ No

116. 	 Classify the recipient’s prescribed preparative regimen: (Allogeneic HCTs only)
	

☐ Myeloablative	 ☐ Non-myeloablative (NST)	

☐ Reduced intensity (RIC)

117. 	 Was irradiation planned as part of the pre-HCT preparative regimen?

	☐ Yes	
	☐ No

118.	 What was the prescribed radiation field?

	☐ Total body
	☐ Total body by intensity-modulated radiation therapy (IMRT)
	☐ Total lymphoid or nodal regions
	☐ Thoracoabdominal region
119.	 Total prescribed dose: (dose per fraction x total number of 		
	

fractions) ___ ___ ___ ● ___ __	

☐ Gy	

☐ cGy

120.	 Date started: __ __ __ __ / __ __ / __ __
	
YYYY
MM
DD
121.	 Was the radiation fractionated?

	☐ Yes
	☐ No

122.	Total number of fractions: ___ ___

CIBMTR Form 2400 revision 6 (page 14 of 17). Form released November, 2018. Last Updated April, 2019.
Copyright (c) 2018 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___	

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Indicate the total prescribed cumulative dose for the preparative regimen:
123.	 Drug: (choose from list)

	☐ Bendamustine
	☐ Busulfan
	☐ Carboplatin
	☐ Carmustine (BCNU)
	☐ CCNU (Lomustine)
	☐ Clofarabine (Clolar)
	☐ Cyclophosphamide (Cytoxan)
	☐ Cytarabine (Ara-C)
	☐ Etoposide (VP-16, VePesid)
	☐ Fludarabine
	☐ Gemcitabine
	☐ Ibritumomab tiuxetan (Zevalin)
	☐ Ifosfamide
	☐ Melphalan (L-Pam)
	☐ Methylprednisolone (Solu-Medrol)
	☐ Pentostatin
	☐ Propylene glycol-free melphalan (Evomela)
	☐ Rituximab (Rituxan)
	☐ Thiotepa
	☐ Tositumomab (Bexxar)
	☐ Treosulfan
	☐ Other drug
124.	Specify other drug:_________________________
125.	 Total prescribed dose: __ __ __ __ ● __ 	☐ mg/m2	

☐ mg/kg	 ☐ AUC

126.	 Date started: __ __ __ __ / __ __ / __ __
	
YYYY
MM
DD
127.	 Specify administration: (busulfan only)	☐ Oral	☐ IV	☐ Both
Copy and complete question 123-126 to report each drug given for the preparative
regimen

CIBMTR Form 2400 revision 6 (page 15 of 17). Form released November, 2018. Last Updated April, 2019.
Copyright (c) 2018 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___	

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Additional drugs given in the peri-transplant period
128.	 ALG, ALS, ATG, ATS

	☐ Yes	
	
☐ No

129.	 Total prescribed dose: ___ ___ ___ ___ ___ mg/kg
130.	 Specify source:

	☐ ATGAM (horse)
	☐ ATG – Fresenius (rabbit)
	☐ Thymoglobulin (rabbit)
	☐ Other

131.	Specify other source:_______________________

132.	 Alemtuzumab (Campath)

	☐ Yes	
	
☐ No

133.	 Total prescribed dose: __ __ __ __ ● __ 	☐ mg/m2	

☐ mg/kg	 ☐ mg

134.	 Defibrotide	☐ Yes	

135.	 KGF	☐ Yes	
136.	 Ursodiol	☐ Yes	

☐ No
☐ No
☐ No

GVHD Prophylaxis
This section is to be completed for allogeneic HCTs only; autologous HCTs continue with question 141
137.	 Was GVHD prophylaxis planned?

	☐ Yes	
	
☐ No

138.	 Specify drugs / intervention: (check all that apply)

	☐ Abatacept
	☐ Anti CD 25 (Zenapax, Daclizumab, AntiTAC)
	☐ Bortezomib
	☐ CD34 enriched (CD34+ selection)
	☐ Corticosteroids (systemic)
	☐ Cyclosporine (CSA, Neoral, Sandimmune)
	☐ Cyclophosphamide (Cytoxan)
	☐ Extra-corporeal photopheresis (ECP)
	☐ Ex-vivo T-cell depletion
	☐ Filgotinib
	☐ Maraviroc
	☐ Methotrexate (MTX) (Amethopterin)
	☐ Mycophenolate mofetil (MMF) (CellCept)
	☐ Ruxolotinib
	☐ Sirolimus (Rapamycin, Rapamune)
	☐ Tocilizumab
	☐ Tacrolimus (FK 506)
	☐ Blinded randomized trial
	☐ Other agent

139.	Specify other agent:________________________
	
(do not report ATG, campath)

CIBMTR Form 2400 revision 6 (page 16 of 17). Form released November, 2018. Last Updated April, 2019.
Copyright (c) 2018 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

CIBMTR Center Number: ___ ___ ___ ___ ___	

CIBMTR Recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Post-HCT Disease Therapy Planned as of Day 0
140. 	Is additional post-HCT therapy planned?

	☐ Yes	
	
☐ No

Questions 141-142 are optional for non-U.S. centers
141.	 Specify post-HCT therapy planned: (check all that apply)

	☐ Azacytidine (Vidaza)
	☐ Blinatumomab
	☐ Bortezomib (Velcade)
	☐ Bosutinib
	☐ Brentuximab
	☐ Carfilzomib
	☐ Cellular therapy (e.g. DCI, DLI)
	☐ Crenolanib
	☐ Daratumumab
	☐ Dasatinib
	☐ Decitabine
	☐ Elotuzumab
	☐ Enasidenib
	☐ Gilteritinib
	☐ Ibrutinib
	☐ Imatinib mesylate
	☐ Intrathecal therapy (chemotherapy)
	☐ Ivosidenib
	☐ Ixazomib
	☐ Lenalidomide (Revlimid)
	☐ Lestaurtinib
	☐ Local radiotherapy
	☐ Midostaurin
	☐ Nilotinib
	☐ Obinutuzumab
	☐ Pacritinib
	☐ Ponatinib
	☐ Quizartinib
	☐ Rituximab (Rituxan, MabThera)
	☐ Sorafenib
	☐ Sunitinib
	☐ Thalidomide (Thalomid)
	☐ Other therapy
142.	Specify other therapy:______________________
	☐ Unknown
First Name:_____________________________________________________
Last Name:______________________________________________________
E-mail address:__________________________________________________
Date: __ __ __ __ / __ __ / __ __
		 YYYY
MM
DD

CIBMTR Form 2400 revision 6 (page 17 of 17). Form released November, 2018. Last Updated April, 2019.
Copyright (c) 2018 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.


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