1 11.10.2020 2400 Form R8 - Change Memo Package SCTOD OMB

^{Pre-Transplant Essential Data}

LEGEND

REVISON

ADDITION

OMB No: 0915-0310

Expiration Date: 10/31/2022

Public Burden Statement: The purpose of the data collection is to fulfill the legislative mandate to establish and maintain a standardized database of allogeneic marrow and cord blood transplants performed in the United States or using a donor from the United States. The data collected also meets the C.W. Bill Young Cell Transplantation Program requirements to provide relevant scientific information not containing individually identifiable information available to the public in the form of summaries and data sets. 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 information collection is 0915-0310 and it is valid until 10/31/2022. This information collection is voluntary under The Stem Cell Therapeutic and Research Act of 2005, Public Law (Pub. L.) 109–129, as amended by the Stem Cell Therapeutic and Research Reauthorization Act of 2010, Public Law 111–264 (the Act) and the Stem Cell Therapeutic and Research Reauthorization Act of 2015, Public Law 114-104. Public reporting burden for this collection of information is estimated to average 0.68 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 14N136B, Rockville, Maryland, 20857 or [email protected].

CIBMTR Use Only

Sequence Number:

Date Received:

Center Identification

CIBMTR Center Number: ___ ___ ___ ___ ___

EBMT Code (CIC): ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Recipient Identification

CIBMTR Research ID (CRID): ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Event date: __ __ __ __ / __ __ / __ __

YYYY MM DD

Recipient Information

1. Date of birth: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

2. Sex

• Male

• Female

3. Ethnicity

• Hispanic or Latino

• Not Hispanic or Latino

• Not applicable (not a resident of the USA)

• Unknown

4. Race (check all that apply)

• White – Go to question 5

• Black or African American– Go to question 5

• Asian– Go to question 5

• American Indian or Alaska Native– Go to question 5

• Native Hawaiian or Other Pacific Islander– Go to question 5

• Not reported – Go to question 6

• Unknown– Go to question 6

5. 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

6. 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 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 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

7. State of residence of recipient (for residents of Brazil) - Go to question 10

   Acre Alagoas Amapá Amazonas Bahia Ceará Distrito Federal Espírito Santo Goiás

   Maranhão Mato Grosso Mato Grosso do Sul Minas Gerais Pará Paraná Paraíba Pernambuc Piauí

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

8. Province or territory of residence of recipient (for residents of Canada) - Go to question 10

   Provinces Alberta British Columbia Quebec Manitoba New Brunswick Saskatchewan

   Newfoundland and Labrador Nova Scotia Ontario Prince Edward Island Quebec

   Territories Northwest Territories Nunavut Yukon

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

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

   ☐ 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 and Canada recipients only): ___ ___ ___ ___ ___ - ___ ___ ___ ___

(last 4 digits optional)

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

 A

 B

 AB

 O

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

 Positive

 Negative

14. 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)

• Yes (recipient consented) – Go to question 15

• No (recipient declined) - Go to question 1

• Not approached - Go to question 1

• Not applicable (center not participating) - Go to question 1

15. Date form was signed: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

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

• Yes – Go to question 17

• No – Go to question 1

17. Research sample recipient ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

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

 Yes - Go to question 19

 No – Go to question 24

19. Study Sponsor

• BMT CTN – Go to question 21

• RCI BMT – Go to question 21

• PIDTC – Go to question 21

• USIDNET – Go to question 22

• COG – Go to question 22

• Other sponsor – Go to question 20

20. Specify other sponsor: ________________________________ - Go to question 22

21. Study ID Number: _____________________

22. Subject ID: ______________________

23. Specify the ClinicalTrials.gov identification number: NCT __ __ __ __ __ __ __ __

Copy questions 19-23 to report participation in more than one study.

Hematopoietic Cellular Transplant (HCT) and Cellular Therapy

24. 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 – Go to question 25

• No – Go to question 26

25. Specify subsequent HCT planned

• Autologous

• Allogeneic

26. Has the recipient ever had a prior HCT?

 Yes – Go to question 27

 No – Go to question 38

27. Specify the number of prior HCTs: ___ ___

28. Were all prior HCTs reported to the CIBMTR?

• Yes – Go to question 33

• No – Go to question 29

• Unknown – Go to question 29

Copy and complete questions 29- 32 to report all prior HCTs that have not yet been reported to the CIBMTR

29. Date of the prior HCT: ___ ___ ___ ___ — ___ ___ — ___ ___  date estimated

YYYY MM DD

30. Was the prior HCT performed at a different institution?

• Yes – Go to question 31

• No – Go to question 32

Specify the institution that performed the last HCT

31. Name: _______________________________________________________________

City: _______________________________________________________________

State: _________________________________________________________________

Country: _______________________________________________________________

32. What was the HPC source for the prior HCT? (check all that apply)

• Autologous

• Allogeneic, unrelated

• Allogeneic, related

33. Reason for current HCT

• Graft failure / insufficient hematopoietic recovery – Go to question 34

• Persistent primary disease– Go to question 38

• Recurrent primary disease– Go to question 35

• Planned subsequent HCT, per protocol– Go to question 38

• New malignancy (including PTLD and EBV lymphoma) – Go to question 36

• Insufficient chimerism– Go to question 38

• Other– Go to question 37

34. Date of graft failure / rejection: ___ ___ ___ ___ — ___ ___ — ___ ___ – Go to question 38

YYYY MM DD

35. Date of relapse: ___ ___ ___ ___ — ___ ___ — ___ ___ – Go to question 38

YYYY MM DD

36. Date of secondary malignancy: ___ ___ ___ ___ — ___ ___ — ___ ___ – Go to question 38

YYYY MM DD

37. Specify other reason: __________________________ - Go to question 38

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

 Yes – Go to question 39

 No – Go to question 44

Unknown– Go to question 44

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

• Yes – Go to question 44

• No – Go to question 40

• Unknown– Go to question 44

Copy and complete questions 40-43 to report all prior cellular therapies that have not yet been reported to the CIBMTR.

40. Date of the prior cellular therapy: __ __ __ __ -- __ __ -- __ __

YYYY MM DD

41. Was the cellular therapy performed at a different institution?

• Yes – Go to question 42

• No – Go to question 43

Name: ___________________________________________________________________

City:

State:

Country:

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

• Autologous

• Allogeneic, unrelated

• Allogeneic, related

Donor Information

43. Multiple donors?

• Yes – Go to question 45

• No - Go to question 46

44. Specify number of donors: ___ ___

To report more than one donor, copy questions 46-80 and complete for each donor.

45. Specify donor

• Autologous

• Allogeneic, related

• Allogeneic, unrelated

46. Specify product type (check all that apply)

• Bone marrow

• PBSC

• Single cord blood unit

• Other product– Go to question 48

47. Specify other product: _______________________________________

48. Is the product genetically modified?

• Yes

• No

If autologous, go to question 77.

If allogeneic related, go to question 50.

If allogeneic unrelated, go to question 54.

49. 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 51

• HLA-mismatched relative– Go to question 51

50. Specify the biological relationship of the donor to the recipient

• Mother

• Father

• Child

• Sibling

• Fraternal twin

• Maternal aunt

• Maternal uncle

• Maternal cousin

• Paternal aunt

• Paternal uncle

• Paternal cousin

• Grandparent

• Grandchild

• Other biological relative – Go to question 52

Specify other biological relative: _________________________– Go to question 53

51. Degree of mismatch (related donors only)

• HLA-mismatched 1 allele– Go to question 55

• HLA-mismatched >2 alleles (does include haplo-identical donor) – Go to question 55

52. Specify unrelated donor type

• HLA matched unrelated

• HLA mismatched unrelated

53. Did NMDP / Be the Match facilitate the procurement, collection, or transportation of the product?

• Yes

• No

54. Was this donor used for any prior HCTs? (for this recipient)

• Yes

• No

55. NMDP cord blood unit ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ – Go to question 60

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

___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ - Go to question 60

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

___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ - Go to question 60

Global Registration Identifier for Donors (GRID):

__ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __

NMDP cord blood unit, go to question 72

NMDP donor, go to question 72

Non-NMDP unrelated donor, go to question 63

Non-NMDP cord blood unit, go to question 61

58. Is the CBU ID also the ISBT DIN number?

• Yes – Go to question 63

• No – Go to question 62

• Unknown– Go to question 63

59. Specify the ISBT DIN number: ____________________________________

60. Registry or UCB Bank ID: ___ ___ ___ ___ - If ‘Other registry’ go to 64, otherwise go to question 65

61. Specify other Registry or UCB Bank: - Go to question 65

62. Donor date of birth

• Known – Go to question 66

• Unknown – Go to question 67

63. Donor date of birth: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to question 69

YYYY MM DD

64. Donor age

• Known – Go to question 68

 Unknown – Go to question 69

65. Donor age: ___ ___  Months (use only if less than 1 year old)

 Years

Donor sex

• Male

• Female

66. Specify blood type (donor) (non-NMDP allogeneic donors only)

• A

• B

• AB

• O

67. Specify Rh factor (donor) (non-NMDP allogeneic donors only)

• Positive

• Negative

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

• Reactive

• Non-reactive

• Indeterminate

• Not done

• Not applicable (cord blood unit)

69. 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) – Go to question 74

• No (donor declined) - Go to question 77

• Not approached - Go to question 77

• Not applicable (center not participating) - Go to question 77

70. Date form was signed: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

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

• Yes – Go to question 76

• No – Go to question 77

72. Research sample donor ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

73. Specify number of products infused from this donor: ___ ___

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

Questions 79-80 are for autologous HCT recipients only. If other than autologous skip to question 83.

75. 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– Go to question 80

76. Specify other agent: ­­­­­­­­­­­­­­­___________________

77. Name of product: (gene therapy recipients)

• Other name

78. Specify other name: ____________________

To report more than one donor, copy questions 46-82 and complete for each donor.

Clinical Status of Recipient Prior to the Preparative Regimen (Conditioning)

79. What scale was used to determine the recipient’s functional status?

• Karnofsky (recipient age ≥ 16 years) – Go to question 84

• Lansky (recipient age ≥ 1 year and < 16 years) – Go to question 85

Performance score prior to the preparative regimen:

80. Karnofsky Scale (recipient age ≥ 16 years)

• 100 Normal; no complaints; no evidence of disease - Go to question 86

• 90 Able to carry on normal activity - Go to question 86

• 80 Normal activity with effort - Go to question 86

• 70 Cares for self; unable to carry on normal activity or to do active work - Go to question 86

• 60 Requires occasional assistance but is able to care for most needs - Go to question 86

• 50 Requires considerable assistance and frequent medical care - Go to question 86

• 40 Disabled; requires special care and assistance - Go to question 86

• 30 Severely disabled; hospitalization indicated, although death not imminent - Go to question 86

• 20 Very sick; hospitalization necessary - Go to question 86

• 10 Moribund; fatal process progressing rapidly - Go to question 86

81. 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 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

82. Recipient CMV-antibodies (IgG or Total)

• Reactive

• Non-reactive

• Indeterminate

• Not done

Comorbid Conditions

83. 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?

• Yes – Go to question 88

• No – Go to question 90

84. Did the patient require hospitalization for management of COVID-19 (SARS-CoV-2) infection?

• Yes – Go to question 89

• No – Go to question 90

85. Was mechanical ventilation given for COVID-19 (SARS-CoV-2) infection?

• Yes

• No

86. Is there a history of mechanical ventilation (excluding COVID-19 (SARS-CoV-2)?

• Yes

• No

87. Is there a history of invasive fungal infection?

• Yes

• No

88. Glomerular filtration rate (GFR) before start of preparative regimen (pediatric only)

• Known- Go to question 93

• Unknown- Go to question 94

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

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

• Yes

• No

91. 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- Go to question 96

• No- Go to question 102

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/m2 prior to the start of 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 during the 4 weeks prior to transplant; OR prior renal transplantation -go to question 97

• 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-Treated at any time point in the patient’s past history, other than the primary disease for which this infusion is being performed -go to question 98

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

• Yes

• No

• Unknown

93. 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 skin malignancy (basal cell, squamous)- go to question 99

• Other hematologic malignancy -go to question 100

• Other solid tumor, prior -go to question 101

94. Specify other skin malignancy: (prior) _______________________________

95. Specify other hematologic malignancy: (prior) _____________________________

96. Specify other solid tumor: (prior) _______________

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)

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

• Known – Go to question 103

• Unknown – Go to question 106

98. ___ ___ ___ ___ ___ ng/mL (μg/L)

99. Date sample collected: ___ ___ ___ ___ — ___ ___ — ___ ___

• YYYY MM DD

100. Upper limit of normal for your institution: ___ ___ ___ ___ ___

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

• Known – Go to question 107

• Unknown – Go to question 109

102. ___ ___ ● ___  g/dL

 g/L

103. Date sample collected: ___ ___ ___ ___ — ___ ___ — ___ ___

• YYYY MM DD

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

• Known – Go to question 110

• Unknown – Go to question 112

105. ___ ___ ___ ___ ___ ___ ___  x 10⁹/L (x 10³/mm³)

 x 10⁶/L

106. Were platelets transfused < 7 days before date of test?

• Yes

• No

• Unknown

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

• Yes- Go to question 113

• No- Go to question 116

108. Specify organ:

• Bowel

• Heart

• Kidney(s)

• Liver

• Lung(s)

• Pancreas

• Other organ- Go to question 114

109. Specify other organ: _______________________________

110. Year of prior solid organ transplant: ___ ___ ___ ___

• YYYY

Copy and complete questions 113-115 for each prior solid organ transplant

Pre-HCT Preparative Regimen (Conditioning)

111. Height at initiation of pre-HCT preparative regimen: ___ ___ ___  inches

 centimeters

112. Actual weight at initiation of pre-HCT preparative regimen: ___ ___ ___ . ___  pounds

 kilograms

113. Was a pre-HCT preparative regimen prescribed?

• Yes – Go to question 119

• No – Go to question 132

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

• Myeloablative

• Non-myeloablative (NST)

• Reduced intensity (RIC)

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

• Yes – Go to question 121

• No – Go to question 126

116. What was the prescribed radiation field?

• Total body – Go to question 122

• Total body by intensity-modulated radiation therapy (IMRT) – Go to question 122

• Total lymphoid or nodal regions – Go to question 122

• Thoracoabdominal region – Go to question 122

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

 cGy

118. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

119. Was the radiation fractionated?

• Yes – Go to question 125

• No – Go to question 126

120. Total number of fractions: ___ ___

Indicate the total prescribed cumulative dose for the preparative regimen

121. Drug (drop down 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 -go to question 127

122. Specify other drug: ___________

123. Total prescribed dose: __ __ __ __ __. __  mg/m²

 mg/kg

 AUC (mg x h/L)

 AUC (µmol x min/L)

CSS (ng/mL)

124. Date started: ___ ___ ___ ___ — ___ ___ — ___ ___

• YYYY MM DD

125. Specify administration (busulfan only)

• Oral

• IV

• Both

Copy and complete question 126-130 to report each drug given for the preparative regimen

Additional Drugs Given in the Peri-Transplant Period

126. ALG, ALS, ATG, ATS

• Yes – Go to question 132

• No – Go to question 135

127. Total prescribed dose: ___ ___ ___ ___ ___ mg/kg

128. Specify source

• ATGAM (horse) – Go to question 135

• ATG – Fresenius (rabbit) – Go to question 135

• Thymoglobulin (rabbit) – Go to question 135

• Other – Go to question 134

129. Specify other source: _____________________

130. Alemtuzumab (Campath)

• Yes – Go to question 136

• No – Go to question 137

131. Total prescribed dose: __ __ __ __ . __  mg/m2

 mg/kg

mg

132. Defibrotide

• Yes

• No

133. KGF

• Yes

• No

134. Ursodiol

• Yes

• No

GVHD Prophylaxis

This section is to be completed for allogeneic HCTs only; autologous HCTs continue with question 143.

135. Was GVHD prophylaxis planned?

• Yes - Go to question 141

• No - Go to question 143

136. Specify drugs / intervention (check all that apply)

• Abatacept

• Anti CD 25 (Zenapax, Daclizumab, AntiTAC)

• Blinded randomized trial

• Bortezomib

• CD34 enriched (CD34+ selection)

• Corticosteroids (systemic)

• Cyclophosphamide (Cytoxan)

• Cyclosporine (CSA, Neoral, Sandimmune)

• Extra-corporeal photopheresis (ECP)

• Ex-vivo T-cell depletion

• Filgotinib

• Maraviroc

• Methotrexate (MTX) (Amethopterin)

• Mycophenolate mofetil (MMF) (CellCept)

• Ruxolotinib

• Sirolimus (Rapamycin, Rapamune)

• Tacrolimus (FK 506)

• Tocilizumab

• Other agent-go to question 142

137. Specify other agent: ______________ (do not report ATG, campath)

Post-HCT Disease Therapy Planned as of Day 0

138. Is additional post-HCT therapy planned?

 Yes - Go to question 144

 No - Go to First Name

Questions 144-145 are optional for non-U.S. centers

139. 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 (Gleevec, Glivec)

• 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- Go to question 145

• Unknown

140. Specify other therapy: ____________________________

Prior Exposure: Potential Study Eligibility

Selecting any option(s) below may generate an additional supplemental form.

141. Specify if the recipient received any of the following (at any time prior to HCT / infusion) (check all that apply)

• Blinatumomab (Blincyto)

• Gemtuzumab ozogamicin (Mylotarg)

• Inotuzumab ozogamicin (Besponsa)

• Adienne Tepadina^®

• Mogamulizumab (Poteligeo)

• None of the above

First Name: ____________________________________________________________________________

Last Name: ____________________________________________________________________________

E-mail address:

Date: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

CIBMTR Form 2400 R8 (1 – 30) Draft 29Sep2020

Copyright ^© 2007 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.