Document
02.10.2020 Disease Classification Form 2402 Proposed Changes
ICR 202004-0915-001 · OMB 0915-0310 · Object 100106301.
This document may belong to an older filing. More recent activity for OMB 0915-0310:
Document Viewer [docx]
Document Metadata
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
|---|---|
| File Title | 02.10.2020 Disease Classification Form 2402 Proposed Changes |
| Author | Monique Ammi |
| Last Modified By | Writer |
| File Modified | 2020-03-11 |
| File Created | 2026-09-14 |
| Conversion State | complete |
Extracted Text
Registry Use Only
Sequence Number:
Date Received:
CIBMTR Center Number: ___ ___ ___ ___ ___
CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
Event date: ___ ___ ___ ___ — ___ ___ — ___ ___
YYYY MM DD
Primary Disease for HCT / Cellular Therapy
1. Date of diagnosis of primary disease for HCT / cellular therapy: ___ ___ ___ ___ — ___ ___ — ___ ___
YYYY MM DD
2. What was the primary disease for which the HCT / cellular therapy was performed?
• Acute myelogenous leukemia (AML or ANLL) (10) - Go to question 3
• Acute lymphoblastic leukemia (ALL) (20) - Go to question 96
• Acute leukemia of ambiguous lineage and other myeloid neoplasms (80) - Go to question 164
• Chronic myelogenous leukemia (CML) (40) - Go to question 168
• Myelodysplastic Syndrome (MDS) (50) (If recipient has transformed to AML, indicate AML as the primary disease) - Go to question 179
• Myeloproliferative Neoplasms (MPN) (1460) (If recipient has transformed to AML, indicate AML as the primary disease) - Go to question 260
• Other leukemia (30) (includes CLL) - Go to question 373
• Hodgkin lymphoma (150) - Go to question 380
• Non-Hodgkin lymphoma (100) - Go to question 380
• Multiple myeloma / plasma cell disorder (PCD) (170) - Go to question 398
• Solid tumors (200) - Go to question 446
• Severe aplastic anemia (300) (If the recipient developed MDS or AML, indicate MDS or AML as the primary disease) - Go to question 448
• Inherited abnormalities of erythrocyte differentiation or function (310) - Go to question 450
• Disorders of the immune system (400) - Go to question 484
• Inherited abnormalities of platelets (500) - Go to question 492
• Inherited disorders of metabolism (520) - Go to question 494
• Histiocytic disorders (570) - Go to question 497
• Autoimmune diseases (600) - Go to question 502
• Tolerance induction associated with solid organ transplant (910) - Go to question 506
• Recessive dystrophic epidermolysis bullosa (920) – Go to First Name
• Other disease (900) - Go to question 508
Acute Myelogenous Leukemia (AML)
3. Specify the AML classification:
AML with recurrent genetic abnormalities
• 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)
• Acute erythroid leukemia (erythroid / myeloid and pure erythroleukemia) (291)
• Acute megakaryoblastic leukemia (292)
• Acute basophilic leukemia (293)
• Acute panmyelosis with myelofibrosis (294)
• Myeloid sarcoma (295)
• Myeloid leukemia associated with Down syndrome (299)
4. Did AML transform from MDS or MPN?
• Yes – Also complete MDS Disease Classification questions
• No
5. Is the disease (AML) therapy related?
• Yes
• No
• Unknown
6. Did the recipient have a predisposing condition?
• Yes - Go to question 7
• No - Go to question 9
• Unknown - Go to question 9
7. Specify condition: _______________________________
• Bloom syndrome - Go to question 9
• Down syndrome - Go to question 9
• Fanconi anemia - Also complete CIBMTR Form 2029 - Go to question 9
• Dyskeratosis congenita - Go to question 9
• Other condition - Go to question 8
8. Specify other condition: __________________________________________
Labs at diagnosis
9. Were cytogenetics tested (karyotyping or FISH)? (at diagnosis)
• Yes - Go to question 10
• No - Go to question 23
• Unknown - Go to question 23
10. Were cytogenetics tested via FISH?
• Yes – Go to question 11
• No - Go to question 16
11. Results of tests:
• Abnormalities identified – Go to question 12
• No abnormalities - Go to question 16
Specify cytogenetic abnormalities identified at diagnosis:
12. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: ___________________________________
13. Specify number of distinct cytogenetic abnormalities:
• One (1)
• Two (2)
• Three (3)
• Four or more (4 or more)
14. Specify abnormalities (check all that apply)
• -5
• -7
• -17
• -18
• -X
• -Y
• +4
• +8
• +11
• +13
• +14
• +21
• +22
• t(3;3)
• t(6;9)
• t(8;21)
• t(9;11)
• t(9;22)
• t(15;17) and variants
• t(16;16)
• del(3q) / 3q–
• del(5q) / 5q–
• del(7q) / 7q–
• del(9q) / 9q–
• del(11q) / 11q–
• del(16q) / 16q–
• del(17q) / 17q–
• del(20q) / 20q–
• del(21q) / 21q–
• inv(3)
• inv(16)
• (11q23) any abnormality
• 12p any abnormality
• Other abnormality - Go to question 15
15. Specify other abnormality: _____________________
16. Were cytogenetics tested via karyotyping?
• Yes – Go to question 17
• No - Go to question 22
17. Results of tests:
• Abnormalities identified – Go to question 18
• No evaluable metaphases - Go to question 22
• No abnormalities - Go to question 22
Specify cytogenetic abnormalities identified at diagnosis:
18. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: _____________________________
19. Specify number of distinct cytogenetic abnormalities:
• One (1)
• Two (2)
• Three (3)
• Four or more (4 or more)
20. Specify abnormalities: (check all that apply)
• -5
• -7
• -17
• -18
• -X
• -Y
• +4
• +8
• +11
• +13
• +14
• +21
• +22
• t(3;3)
• t(6;9)
• t(8;21)
• t(9;11)
• t(9;22)
• t(15;17) and variants
• t(16;16)
• del(3q) / 3q–
• del(5q) / 5q–
• del(7q) / 7q–
• del(9q) / 9q–
• del(11q) / 11q–
• del(16q) / 16q–
• del(17q) / 17q–
• del(20q) / 20q–
• del(21q) / 21q–
• inv(3)
• inv(16)
• (11q23) any abnormality
• 12p any abnormality
• Other abnormality - Go to question 21
21. Specify other abnormality: _____________________
22. Was documentation submitted to the CIBMTR? (e.g. cytogenetic or FISH report)
• Yes
• No
23. Were tests for molecular markers performed (e.g. PCR, NGS)? (at diagnosis)
• Yes – Go to question 24
• No – Go to question 36
• Unknown – Go to question 36
Specify molecular markers identified at diagnosis:
24. CEBPA
• Positive – Go to question 25
• Negative - Go to question 26
• Not done - Go to question 26
25. Specify CEBPA mutation
• Biallelic (homozygous)
• Monoallelic (heterozygous)
• Unknown
26. FLT3 – D835 point mutation
• Positive
• Negative
• Not done
27. FLT3 – ITD mutation
• Positive- Go to question 28
• Negative- Go to question 30
• Not done- Go to question 30
28. FLT3 – ITD allelic ratio
• Known - Go to question 29
• Unknown - Go to question 30
29. Specify FLT3 - ITD allelic ratio: ___ . ___ ___
30. IDH1
• Positive
• Negative
• Not done
31. IDH2
• Positive
• Negative
• Not done
32. KIT
• Positive
• Negative
• Not done
33. NPM1
• Positive
• Negative
• Not done
34. Other molecular marker
• Positive- Go to question 35
• Negative- Go to question 35
• Not done- Go to question 36
35. Specify other molecular marker: _________________________________
Copy and complete questions 34-35 for multiple molecular markers
Labs between diagnosis and last evaluation:
36. Were cytogenetics tested (karyotyping or FISH)? (between diagnosis and last evaluation)
• Yes - Go to question 37
• No - Go to question 50
• Unknown - Go to question 50
37. Were cytogenetics tested via FISH?
• Yes – Go to question 38
• No - Go to question 43
38. Results of tests:
• Abnormalities identified – Go to question 39
• No abnormalities - Go to question 43
Specify cytogenetic abnormalities identified between diagnosis and last evaluation:
39. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: ____________________________
40. Specify number of distinct cytogenetic abnormalities:
• One (1)
• Two (2)
• Three (3)
• Four or more (4 or more)
41. Specify abnormalities (check all that apply)
• -5
• -7
• -17
• -18
• -X
• -Y
• +4
• +8
• +11
• +13
• +14
• +21
• +22
• t(3;3)
• t(6;9)
• t(8;21)
• t(9;11)
• t(9;22)
• t(15;17) and variants
• t(16;16)
• del(3q) / 3q–
• del(5q) / 5q–
• del(7q) / 7q–
• del(9q) / 9q–
• del(11q) / 11q–
• del(16q) / 16q–
• del(17q) / 17q–
• del(20q) / 20q–
• del(21q) / 21q–
• inv(3)
• inv(16)
• (11q23) any abnormality
• 12p any abnormality
• Other abnormality - Go to question 42
42. Specify other abnormality: _____________________
43. Were cytogenetics tested via karyotyping?
• Yes – Go to question 44
• No - Go to question 49
44. Results of tests:
• Abnormalities identified – Go to question 45
• No evaluable metaphases - Go to question 49
• No abnormalities - Go to question 49
Specify cytogenetic abnormalities identified between diagnosis and last evaluation:
45. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: ___________________________
46. Specify number of distinct cytogenetic abnormalities:
• One (1)
• Two (2)
• Three (3)
• Four or more (4 or more)
47. Specify abnormalities: (check all that apply)
• -5
• -7
• -17
• -18
• -X
• -Y
• +4
• +8
• +11
• +13
• +14
• +21
• +22
• t(3;3)
• t(6;9)
• t(8;21)
• t(9;11)
• t(9;22)
• t(15;17) and variants
• t(16;16)
• del(3q) / 3q–
• del(5q) / 5q–
• del(7q) / 7q–
• del(9q) / 9q–
• del(11q) / 11q–
• del(16q) / 16q–
• del(17q) / 17q–
• del(20q) / 20q–
• del(21q) / 21q–
• inv(3)
• inv(16)
• (11q23) any abnormality
• 12p any abnormality
• Other abnormality - Go to question 48
48. Specify other abnormality: _____________________
49. Was documentation submitted to the CIBMTR? (e.g. cytogenetic or FISH report)
• Yes
• No
50. Were tests for molecular markers performed (e.g. PCR, NGS)? (between diagnosis and last evaluation)
• Yes – Go to question 51
• No – Go to question 63
• Unknown – Go to question 63
Specify molecular markers identified between diagnosis and last evaluation:
51. CEBPA
• Positive – Go to question 52
• Negative - Go to question 53
• Not done - Go to question 53
52. Specify CEBPA mutation
• Biallelic (homozygous)
• Monoallelic (heterozygous)
• Unknown
53. FLT3 – D835 point mutation
• Positive
• Negative
• Not done
54. FLT3 – ITD mutation
• Positive- Go to question 55
• Negative- Go to question 57
• Not done- Go to question 57
55. FLT3 – ITD allelic ratio
• Known - Go to question 56
• Unknown - Go to question 57
56. Specify FLT3 - ITD allelic ratio: ___ . ___
57. IDH1
• Positive
• Negative
• Not done
58. IDH2
• Positive
• Negative
• Not done
59. KIT
• Positive
• Negative
• Not done
60. NPM1
• Positive
• Negative
• Not done
61. Other molecular marker:
• Positive- Go to question 62
• Negative- Go to question 62
• Not done- Go to question 63
62. Specify other molecular marker: _________________________________
Copy and complete questions 61-62 to report multiple other molecular markers
Labs at last evaluation:
63. Were cytogenetics tested (karyotyping or FISH)? (at last evaluation)
• Yes - Go to question 64
• No - Go to question 77
• Unknown - Go to question 77
64. Were cytogenetics tested via FISH?
• Yes – Go to question 65
• No - Go to question 70
65. Results of tests:
• Abnormalities identified – Go to question 66
• No abnormalities - Go to question 70
Specify cytogenetic abnormalities identified at last evaluation:
66. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: ______________________
67. Specify number of distinct cytogenetic abnormalities:
• One (1)
• Two (2)
• Three (3)
• Four or more (4 or more)
68. Specify abnormalities (check all that apply)
• -5
• -7
• -17
• -18
• -X
• -Y
• +4
• +8
• +11
• +13
• +14
• +21
• +22
• t(3;3)
• t(6;9)
• t(8;21)
• t(9;11)
• t(9;22)
• t(15;17) and variants
• t(16;16)
• del(3q) / 3q–
• del(5q) / 5q–
• del(7q) / 7q–
• del(9q) / 9q–
• del(11q) / 11q–
• del(16q) / 16q–
• del(17q) / 17q–
• del(20q) / 20q–
• del(21q) / 21q–
• inv(3)
• inv(16)
• (11q23) any abnormality
• 12p any abnormality
• Other abnormality - Go to question 69
69. Specify other abnormality: _____________________
70. Were cytogenetics tested via karyotyping?
• Yes – Go to question 71
• No - Go to question 76
71. Results of tests:
• Abnormalities identified – Go to question 72
• No evaluable metaphases - Go to question 76
• No abnormalities - Go to question 76
Specify cytogenetic abnormalities identified at last evaluation:
72. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: _________________________
73. Specify number of distinct cytogenetic abnormalities:
• One (1)
• Two (2)
• Three (3)
• Four or more (4 or more)
74. Specify abnormalities: (check all that apply)
• -5
• -7
• -17
• -18
• -X
• -Y
• +4
• +8
• +11
• +13
• +14
• +21
• +22
• t(3;3)
• t(6;9)
• t(8;21)
• t(9;11)
• t(9;22)
• t(15;17) and variants
• t(16;16)
• del(3q) / 3q–
• del(5q) / 5q–
• del(7q) / 7q–
• del(9q) / 9q–
• del(11q) / 11q–
• del(16q) / 16q–
• del(17q) / 17q–
• del(20q) / 20q–
• del(21q) / 21q–
• inv(3)
• inv(16)
• (11q23) any abnormality
• 12p any abnormality
• Other abnormality - Go to question 75
75. Specify other abnormality: _____________________
76. Was documentation submitted to the CIBMTR? (e.g. cytogenetic or FISH report)
• Yes
• No
77. Were tests for molecular markers performed (e.g. PCR, NGS)? (at last evaluation)
• Yes – Go to question 78
• No – Go to question 90
• Unknown – Go to question 90
Specify molecular markers identified at last evaluation:
78. CEBPA
• Positive – Go to question 79
• Negative - Go to question 80
• Not done - Go to question 80
79. Specify CEBPA mutation
• Biallelic (homozygous)
• Monoallelic (heterozygous)
• Unknown
80. FLT3 – D835 point mutation
• Positive
• Negative
• Not done
81. FLT3 – ITD mutation
• Positive- Go to question 82
• Negative- Go to question 84
• Not done- Go to question 84
82. FLT3 – ITD allelic ratio
• Known - Go to question 83
• Unknown - Go to question 84
83. Specify FLT3 - ITD allelic ratio: ___ . ___
84. IDH1
• Positive
• Negative
• Not done
85. IDH2
• Positive
• Negative
• Not done
86. KIT
• Positive
• Negative
• Not done
87. NPM1
• Positive
• Negative
• Not done
88. Other molecular marker
• Positive- Go to question 89
• Negative- Go to question 89
• Not done- Go to question 90
89. Specify other molecular marker: _________________________________
Copy and complete questions 88-89 to report multiple other molecular markers
CNS Leukemia
90. Did the recipient have central nervous system leukemia at any time prior to the start of the preparative regimen / infusion?
• Yes
• No
• Unknown
Status at transplantation / infusion:
91. What was the disease status (based on hematological test results)?
• Primary induction failure – Go to question 95
• 1st complete remission (no previous bone marrow or extramedullary relapse) (include CRi)– Go to question 92
• 2nd complete remission – Go to question 92
• ≥ 3rd complete remission – Go to question 92
• 1st relapse – Go to question 94
• 2nd relapse – Go to question 94
• ≥ 3rd relapse – Go to question 94
• No treatment – Go to question 95
92. How many cycles of induction therapy were required to achieve 1st complete remission? (includes CRi)
• 1
• 2
• ≥ 3
93. Was the recipient in remission by flow cytometry?
• Yes – Go to question 95
• No – Go to question 95
• Unknown – Go to question 95
• Not applicable – Go to question 95
94. Date of most recent relapse: ___ ___ ___ ___ — ___ ___ — ___ ___
YYYY MM DD
95. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line
YYYY MM DD
Acute Lymphoblastic Leukemia (ALL)
96. Specify ALL classification:
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-ABL1-like (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)
97. Did the recipient have a predisposing condition?
• Yes - Go to question 98
• No - Go to question 100
• Unknown - Go to question 100
98. Specify condition:
• Aplastic anemia - Go to question 100 Also complete CIBMTR Form 2028 — APL
• Bloom syndrome - Go to question 100
• Down syndrome - Go to question 100
• Fanconi anemia - Go to question 100 Also complete CIBMTR Form 2029 — FAN
• Other condition - Go to question 99
99. Specify other condition: _________________________________________
100. Were tyrosine kinase inhibitors given for therapy at any time prior to start of the preparative regimen / infusion? (e.g. imatinib mesylate, dasatinib, etc.)
• Yes
• No
Laboratory studies at diagnosis:
101. Were cytogenetics tested (karyotyping or FISH)? (at diagnosis)
• Yes - Go to question 102
• No - Go to question 115
• Unknown - Go to question 115
102. Were cytogenetics tested via FISH? (at diagnosis)
• Yes - Go to question 103
• No - Go to question 108
103. Results of tests: (at diagnosis)
• Abnormalities identified - Go to question 104
• No abnormalities - Go to question 108
Specify cytogenetic abnormalities identified at diagnosis:
104. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: ____________________________
105. Specify number of distinct cytogenetic abnormalities:
• One (1)
• Two (2)
• Three (3)
• Four or more (4 or more)
106. Specify abnormalities: (check all that apply)
• –7
• +4
• +8
• +17
• +21
• t(1;19)
• t(2;8)
• t(4;11)
• t(5;14)
• t(8;14)
• t(8;22)
• t(9;22)
• t(10;14)
• t(11;14)
• t(12;21)
• del(6q) / 6q–
• del(9p) / 9p–
• del(12p) / 12p–
• add(14q)
• (11q23) any abnormality
• 9p any abnormality
• 12p any abnormality
• Hyperdiploid (> 50)
• Hypodiploid (< 46)
• iAMP21
• Other abnormality – Go to question 107
107. Specify other abnormality: _______________________________
108. Were cytogenetics tested via karyotyping? (at diagnosis)
• Yes - Go to question 109
• No - Go to question 114
109. Results of tests: (at diagnosis)
• Abnormalities identified - Go to question 110
• No evaluable metaphases - Go to question 114
• No abnormalities - Go to question 114
Specify cytogenetic abnormalities identified at diagnosis:
110. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: ______________________________
111. Specify number of distinct cytogenetic abnormalities:
• One (1)
• Two (2)
• Three (3)
• Four or more (4 or more)
112. Specify abnormalities: (check all that apply)
• –7
• +4
• +8
• +17
• +21
• t(1;19)
• t(2;8)
• t(4;11)
• t(5;14)
• t(8;14)
• t(8;22)
• t(9;22)
• t(10;14)
• t(11;14)
• t(12;21)
• del(6q) / 6q–
• del(9p) / 9p–
• del(12p) / 12p–
• add(14q)
• (11q23) any abnormality
• 9p any abnormality
• 12p any abnormality
• Hyperdiploid (> 50)
• Hypodiploid (< 46)
• iAMP21
• Other abnormality – Go to question 113
113. Specify other abnormality: _________________________
114. Was documentation submitted to the CIBMTR? (e.g. cytogenetic or FISH report)
• Yes
• No
115. Were tests for molecular markers performed (e.g. PCR, NGS)? (at diagnosis)
• Yes – Go to question 116
• No – Go to question 120
• Unknown – Go to question 120
Specify molecular markers identified at diagnosis:
116. BCR / ABL
• Positive
• Negative
• Not done
117. TEL-AML / AML1
• Positive
• Negative
• Not done
118. Other molecular marker
• Positive – Go to question 119
• Negative – Go to question 119
• Not done – Go to question 120
119. Specify other molecular marker: ______________________________
Copy and complete questions 118-119 for additional molecular markers
Laboratory studies between diagnosis and last evaluation:
120. Were cytogenetics tested (karyotyping or FISH)? (between diagnosis and last evaluation)
• Yes - Go to question 121
• No - Go to question 134
• Unknown - Go to question 134
121. Were cytogenetics tested via FISH? (between diagnosis and the last evaluation)
• Yes - Go to question 122
• No - Go to question 127
122. Results of tests: (between diagnosis and the last evaluation)
• Abnormalities identified - Go to question 123
• No abnormalities - Go to question 127
Specify cytogenetic abnormalities identified between diagnosis and last evaluation:
123. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: _____________________________
124. Specify number of distinct cytogenetic abnormalities:
• One (1)
• Two (2)
• Three (3)
• Four or more (4 or more)
125. Specify abnormalities: (check all that apply)
• –7
• +4
• +8
• +17
• +21
• t(1;19)
• t(2;8)
• t(4;11)
• t(5;14)
• t(8;14)
• t(8;22)
• t(9;22)
• t(10;14)
• t(11;14)
• t(12;21)
• del(6q) / 6q–
• del(9p) / 9p–
• del(12p) / 12p–
• add(14q)
• (11q23) any abnormality
• 9p any abnormality
• 12p any abnormality
• Hyperdiploid (> 50)
• Hypodiploid (< 46)
• iAMP21
• Other abnormality – Go to question 126
126. Specify other abnormality: ___________________________
127. Were cytogenetics tested via karyotyping? (between diagnosis and the last evaluation)
• Yes - Go to question 128
• No - Go to question 133
128. Results of tests: (between diagnosis and the last evaluation)
• Abnormalities identified - Go to question 129
• No evaluable metaphases - Go to question 133
• No abnormalities - Go to question 133
Specify cytogenetic abnormalities identified between diagnosis and last evaluation:
129. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: _______________________
130. Specify number of distinct cytogenetic abnormalities:
• One (1)
• Two (2)
• Three (3)
• Four or more (4 or more)
131. Specify abnormalities: (check all that apply)
• –7
• +4
• +8
• +17
• +21
• t(1;19)
• t(2;8)
• t(4;11)
• t(5;14)
• t(8;14)
• t(8;22)
• t(9;22)
• t(10;14)
• t(11;14)
• t(12;21)
• del(6q) / 6q–
• del(9p) / 9p–
• del(12p) / 12p–
• add(14q)
• (11q23) any abnormality
• 9p any abnormality
• 12p any abnormality
• Hyperdiploid (> 50)
• Hypodiploid (< 46)
• iAMP21
• Other abnormality – Go to question 132
132. Specify other abnormality: _________________________
133. Was documentation submitted to the CIBMTR? (e.g. cytogenetic or FISH report)
• Yes
• No
134. Were tests for molecular markers performed (e.g. PCR, NGS)? (between diagnosis and last evaluation)
• Yes – Go to question 135
• No – Go to question 139
• Unknown – Go to question 139
Specify molecular markers identified between diagnosis and last evaluation:
135. BCR / ABL
• Positive
• Negative
• Not done
136. TEL-AML / AML1
• Positive
• Negative
• Not done
137. Other molecular marker
• Positive – Go to question 138
• Negative – Go to question 138
• Not done – Go to question 139
138. Specify other molecular marker: _________________________
Copy and complete questions 137-138 for additional molecular markers
Laboratory studies at last evaluation:
139. Were cytogenetics tested (karyotyping or FISH)? (at last evaluation)
• Yes - Go to question 140
• No - Go to question 153
• Unknown - Go to question 153
140. Were cytogenetics tested via FISH?
• Yes - Go to question 141
• No - Go to question 146
141. Results of tests:
• Abnormalities identified - Go to question 142
• No abnormalities - Go to question 146
Specify cytogenetic abnormalities identified at last evaluation:
142. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: _________________________
143. Specify number of distinct cytogenetic abnormalities:
• One (1)
• Two (2)
• Three (3)
• Four or more (4 or more)
144. Specify abnormalities: (check all that apply)
• –7
• +4
• +8
• +17
• +21
• t(1;19)
• t(2;8)
• t(4;11)
• t(5;14)
• t(8;14)
• t(8;22)
• t(9;22)
• t(10;14)
• t(11;14)
• t(12;21)
• del(6q) / 6q–
• del(9p) / 9p–
• del(12p) / 12p–
• add(14q)
• (11q23) any abnormality
• 9p any abnormality
• 12p any abnormality
• Hyperdiploid (> 50)
• Hypodiploid (< 46)
• iAMP21
• Other abnormality – Go to question 145
145. Specify other abnormality: ____________________
146. Were cytogenetics tested via karyotyping? (at last evaluation)
• Yes - Go to question 147
• No - Go to question 152
147. Results of tests:
• Abnormalities identified - Go to question 148
• No evaluable metaphases - Go to question 152
• No abnormalities - Go to question 152
Specify cytogenetic abnormalities identified at last evaluation:
148. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: _______________________________
149. Specify number of distinct cytogenetic abnormalities:
• One (1)
• Two (2)
• Three (3)
• Four or more (4 or more)
150. Specify abnormalities: (check all that apply)
• –7
• +4
• +8
• +17
• +21
• t(1;19)
• t(2;8)
• t(4;11)
• t(5;14)
• t(8;14)
• t(8;22)
• t(9;22)
• t(10;14)
• t(11;14)
• t(12;21)
• del(6q) / 6q–
• del(9p) / 9p–
• del(12p) / 12p–
• add(14q)
• (11q23) any abnormality
• 9p any abnormality
• 12p any abnormality
• Hyperdiploid (> 50)
• Hypodiploid (< 46)
• iAMP21
• Other abnormality – Go to question 151
151. Specify other abnormality: ____________________
152. Was documentation submitted to the CIBMTR? (e.g. cytogenetic or FISH report)
• Yes
• No
153. Were tests for molecular markers performed (e.g. PCR, NGS)? (at last evaluation)
• Yes – Go to question 154
• No – Go to question 158
• Unknown – Go to question 158
Specify molecular markers identified at last evaluation:
154. BCR / ABL
• Positive
• Negative
• Not done
155. TEL-AML / AML1
• Positive
• Negative
• Not done
156. Other molecular marker
• Positive – Go to question 157
• Negative – Go to question 157
• Not done – Go to question 158
157. Specify other molecular marker: ___________________________
Copy and complete questions 156-157 for additional molecular markers
CNS Leukemia
158. Did the recipient have central nervous system leukemia at any time prior to the start of the preparative regimen / infusion?
• Yes
• No
• Unknown
Status at transplantation / infusion:
159. What was the disease status (based on hematological test results)?
• Primary induction failure – Go to question 163
• 1st complete remission (no previous marrow or extramedullary relapse)(include CRi) – Go to question 160
• 2nd complete remission – Go to question 160
• ≥ 3rd complete remission – Go to question 160
• 1st relapse – Go to question 162
• 2nd relapse – Go to question 162
• ≥ 3rd relapse – Go to question 162
• No treatment – Go to question 163
160. How many cycles of induction therapy were required to achieve 1st complete remission (include CRi)?
• 1
• 2
• ≥ 3
161. Was the recipient in remission by flow cytometry?
• Yes – Go to question 163
• No – Go to question 163
• Unknown – Go to question 163
• Not applicable – Go to question 163
162. Date of most recent relapse: ___ ___ ___ ___ — ___ ___ — ___ ___
YYYY MM DD
163. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line
YYYY MM DD
Acute Leukemias of Ambiguous Lineage and Other Myeloid Neoplasms
164. Specify acute leukemias of ambiguous lineage and other myeloid neoplasm classification:
• Blastic plasmacytoid dendritic cell neoplasm (296) – Go to question 166
• Acute undifferentiated leukemia (31) – Go to question 166
• Mixed phenotype acute leukemia (MPAL) with t(9;22)(q34.1;q11.2); BCR-ABL1 (84) – Go to question 166
• Mixed phenotype acute leukemia with t(v; 11q23.3); KMT2A rearranged (85) – Go to question 166
• Mixed phenotype acute leukemia, B/myeloid, NOS (86) – Go to question 166
• Mixed phenotype acute leukemia, T/myeloid, NOS (87) – Go to question 166
• Other acute leukemia of ambiguous lineage or myeloid neoplasm (88) - Go to question 165
165. Specify other acute leukemia of ambiguous lineage or myeloid neoplasm: __________________
Status at transplantation / infusion:
166. What was the disease status (based on hematological test results)?
• Primary induction failure
• 1st complete remission (no previous marrow or extramedullary relapse)
• 2nd complete remission
• ≥ 3rd complete remission
• 1st relapse
• 2nd relapse
• ≥3rd relapse
• No treatment
167. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line
YYYY MM DD
Chronic Myelogenous Leukemia (CML)
168. Was therapy given prior to this HCT?
• Yes - Go to question 169
• No - Go to question 175
169. Combination chemotherapy
• Yes
• No
170. Hydroxyurea (Droxia, Hydrea)
• Yes
• No
171. Tyrosine kinase inhibitor (e.g.imatinib mesylate, dasatinib, nilotinib)
• Yes
• No
172. Interferon-α (Intron, Roferon) (includes PEG)
• Yes
• No
173. Other therapy
• Yes - Go to question 174
• No - Go to question 175
174. Specify other therapy: ______________________________________
175. What was the disease status?
• Complete hematologic response (CHR) preceded only by chronic phase- Go to question 176
• Complete hematologic response (CHR) preceded by accelerated phase and/or blast phase- Go to question 176
• Chronic phase – Go to question 176
• Accelerated phase - Go to question 177
• Blast phase - Go to question 177
176. Specify level of response
• No cytogenetic response (No CyR)
• Minimal cytogenetic response
• Minor cytogenetic response
• Partial cytogenetic response (PCyR)
• Complete cytogenetic response (CCyR)
• Major molecular remission (MMR)
• Complete molecular remission (CMR)
177. Number
• 1st
• 2nd
• 3rd or higher
178. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line
YYYY MM DD
Myelodysplastic Syndrome (MDS)
179. What was the MDS subtype at diagnosis? – If transformed to AML, indicate AML as primary disease; also complete AML Disease Classification questions
• Atypical chronic myeloid leukemia (aCML), BCR-ABL1 (1440) – Go to question 218
• Chronic myelomonocytic leukemia (CMMoL) (54) – Go to question 182
• Juvenile myelomonocytic leukemia (JMML) (36) – Go to question 218
• Myelodysplastic syndrome / myeloproliferative neoplasm, unclassifiable (69) – Go to question 181
• MDS / MPN with ring sideroblasts and thrombocytosis (MDS / MPN–RS–T) (1452) – Go to question 182
• Myelodysplastic syndrome (MDS), unclassifiable (50)– Go to question 180
• Myelodysplastic syndrome with isolated del(5q) (66)– Go to question 182
• Myelodysplastic syndrome with multilineage dysplasia (MDS-MLD) (64) – Go to question 182
• Myelodysplastic syndrome with single lineage dysplasia (MDS-SLD) (51) – Go to question 182
• Refractory cytopenia of childhood (68)– Go to question 182
Myelodysplastic syndrome with excess blasts (MDS-EB)
• MDS with excess blasts-1 (MDS-EB-1) (61) – Go to question 182
• MDS with excess blasts-2 (MDS-EB-2) (62) – Go to question 182
Myelodysplastic syndrome with ring sideroblasts (MDS-RS)
• MDS-RS with single lineage dysplasia (MDS-RS-SLD) (1453) – Go to question 182
• MDS-RS with multilineage dysplasia (MDS-RS-MLD) (1454) – Go to question 182
180. Specify Myelodysplastic syndrome, unclassifiable (MDS-U)
• MDS-U with 1% blood blasts
• MDS-U with single lineage dysplasia and pancytopenia
• MDS-U based on defining cytogenetic abnormality
181. Was documentation submitted to the CIBMTR (e.g. pathology report used for diagnosis)?
• Yes
• No
182. Was the disease MDS therapy related?
• Yes
• No
• Unknown
183. Did the recipient have a predisposing condition?
• Yes – Go to question 184
• No – Go to question 186
• Unknown – Go to question 186
184. Specify condition
• Aplastic anemia – Go to question 186
• DDX41-associated familial MDS – Go to question 186
• Diamond-Blackfan Anemia – Go to question 186
• Fanconi anemia –Go to question 186
• GATA2 deficiency (including Emberger syndrome, MonoMac syndrome, DCML deficiency) – Go to question 186
• Li-Fraumeni Syndrome – Go to question 186
• Paroxysmal nocturnal hemoglobinuria – Go to question 186
• RUNX1 deficiency (previously “familial platelet disorder with propensity to myeloid malignancies”) – Go to question 186
• SAMD9- or SAMD9L-associated familial MDS – Go to question 186
• Shwachman-Diamond Syndrome – Go to question 186
• Telomere biology disorder (including dyskeratosis congenita) – Go to question 186
• Other condition – Go to question 185
185. Specify other condition: _______________________
Laboratory studies at diagnosis of MDS:
186. Date CBC drawn: ___ ___ ___ ___ — ___ ___ — ___ ___
YYYY MM DD
187. WBC
• Known – Go to question 188
• Unknown – Go to question 189
188. ___ ___ ___ ___ ___ ___ ● ___ x 109/L (x 103/mm3)
x 106/L
189. Neutrophils
• Known – Go to question 190
• Unknown – Go to question 191
190. ___ ___%
191. Blasts in blood
• Known – Go to question 192
• Unknown– Go to question 193
192. ___ ___ ___ %
193. Hemoglobin
• Known – Go to question 194
• Unknown – Go to question 196
194. ___ ___ ___ ___ ● ___ ___ g/dL
3. g/L
4. mmol/L
195. Were RBCs transfused ≤ 30 days before date of test?
• Yes
• No
196. Platelets
• Known – Go to question 197
• Unknown – Go to question 199
197. ___ ___ ___ ___ ___ ___ ___ x 109/L (x 103/mm3)
x 106/L
198. Were platelets transfused ≤ 7 days before date of test?
• Yes
• No
199. Blasts in bone marrow
• Known – Go to question 200
• Unknown – Go to question 201
200. ___ ___ ___ %
201. Were cytogenetics tested (karyotyping or FISH)?
• Yes – Go to question 202
• No – Go to question 218
• Unknown – Go to question 218
202. Were cytogenetics tested via FISH?
• Yes- Go to question 203
• No- Go to question 210
203. Sample source
• Blood
• Bone Marrow
204. Results of tests:
• Abnormalities identified – Go to question 205
• No abnormalities – Go to question 209
Specify cytogenetic abnormalities identified via FISH at diagnosis:
205. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: __________________________
206. Specify number of distinct cytogenetic abnormalities:
• One (1)
• Two (2)
• Three (3)
• Four or more (4 or more)
207. Specify abnormalities: (check all that apply)
Monosomy
• –5
• –7
• –13
• –20
• –Y
Trisomy
• +8
• +19
Translocation
• t(1;3)
• t(2;11)
• t(3;3)
• t(3;21)
• t(6;9)
• t(11;16)
Deletion
• del(3q) / 3q-
• del(5q) / 5q-
• del(7q) / 7q-
• del(9q) / 9q-
• del(11q) / 11q-
• del(12p) / 12p-
• del(13q) / 13q-
• del(20q) / 20q-
Inversion
• inv(3)
Other
• i17q
• Other abnormality – Go to question 208
208. Specify other abnormality:__________________________
209. Was documentation submitted to the CIBMTR? (e.g. FISH report)
• Yes
• No
210. Were cytogenetics tested via karyotyping?
• Yes- Go to question 211
• No- Go to question 218
211. Sample source
• Blood
• Bone marrow
212. Results of tests
• Abnormalities identified – Go to question 213
• No evaluable metaphases- Go to question 217
• No abnormalities – Go to question 217
Specify cytogenetic abnormalities identified via conventional cytogenetics at diagnosis:
213. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: __________________________
214. Specify number of distinct cytogenetic abnormalities
• One (1)
• Two (2)
• Three (3)
• Four or more (4 or more)
215. Specify abnormalities (check all that apply)
Monosomy
• –5
• –7
• –13
• –20
• –Y
Trisomy
• +8
• +19
Translocation
• t(1;3)
• t(2;11)
• t(3;3)
• t(3;21)
• t(6;9)
• t(11;16)
Deletion
• del(3q) / 3q-
• del(5q) / 5q-
• del(7q) / 7q-
• del(9q) / 9q-
• del(11q) / 11q-
• del(12p) / 12p-
• del(13q) / 13q-
• del(20q) / 20q-
Inversion
• inv(3)
Other
• i17q
• Other abnormality – Go to question 216
216. Specify other abnormality:__________________________
217. Was documentation submitted to the CIBMTR? (e.g. karyotyping report)
• Yes
• No
218. Did the recipient progress or transform to a different MDS subtype or AML between diagnosis and the start of the preparative regimen / infusion?
• Yes – Go to question 219
• No – Go to question 223
219. Specify the MDS subtype or AML after transformation
• Chronic myelomonocytic leukemia (CMMoL) (54) – Go to question 221
• Myelodysplastic syndrome / myeloproliferative neoplasm, unclassifiable (69) – Go to question 221
• MDS / MPN with ring sideroblasts and thrombocytosis (MDS / MPN–RS–T) (1452) – Go to question 221
• Myelodysplastic syndrome (MDS), unclassifiable (50) – Go to question 220
• Myelodysplastic syndrome with isolated del(5q) (66) – Go to question 221
• Myelodysplastic syndrome with multilineage dysplasia (MDS-MLD) (64) – Go to question 221
• Myelodysplastic syndrome with single lineage dysplasia (MDS-SLD)) (51) – Go to question 221
• Refractory cytopenia of childhood (68) – Go to question 221
• Transformed to AML (70) – Go to question 222
Myelodysplastic syndrome with excess blasts (MDS-EB)
• MDS with excess blasts-1 (MDS-EB-1) (61) – Go to question 221
• MDS with excess blasts02 (MDS-EB-2) (62) – Go to question 221
Myelodysplastic syndrome with ring sideroblasts
• MDS-RS with single lineage dysplasia (MDS-RS-SLD) (1453) – Go to question 221
• MDS-RS with multilineage dysplasia (MDS-RS-MLD) (1454) – Go to question 221
220. Specify Myelodysplastic syndrome, unclassifiable (MDS-U)
• MDS-U with 1% blood blasts– Go to question 221
• MDS-U with single lineage dysplasia and pancytopenia– Go to question 221
• MDS-U based on defining cytogenetic abnormality– Go to question 221
221. Specify the date of the most recent transformation:___ ___ ___ ___ — ___ ___ — ___ ___ - Go to question 223
222. Date of MDS diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___ – Go to signature line
Laboratory studies at last evaluation prior to the start of the preparative regimen / infusion:
223. Date CBC drawn: ___ ___ ___ ___ — ___ ___ — ___ ___
YYYY MM DD
224. WBC
• Known – Go to question 225
• Unknown – Go to question 226
225. ___ ___ ___ ___ ___ ___ ● ___ x 109/L (x 103/mm3)
x 106/L
226. Neutrophils
• Known – Go to question 227
• Unknown – Go to question 228
227. ___ ___%
228. Blasts in blood
• Known – Go to question 229
• Unknown – Go to question 230
229. ___ ___ ___ %
230. Hemoglobin
• Known – Go to question 231
• Unknown – Go to question 233
231. ___ ___ ___ ___ ● ___ ___ g/dL
5. g/L
6. mmol/L
232. Were RBCs transfused ≤ 30 days before date of test?
• Yes
• No
233. Platelets
• Known – Go to question 234
• Unknown – Go to question 226
234. ___ ___ ___ ___ ___ ___ ___ x 109/L (x 103/mm3)
x 106/L
235. Were platelets transfused ≤ 7 days before date of test?
• Yes
• No
236. Blasts in bone marrow
• Known – Go to question 237
• Unknown – Go to question 238
237. ___ ___ ___ %
238. Were cytogenetics tested (karyotyping or FISH)?
• Yes – Go to question 239
• No – Go to question 255
• Unknown – Go to question 255
239. Were cytogenetics tested via FISH?
• Yes- Go to question 240
• No- Go to question 246
240. Sample source
• Blood
• Bone Marrow
241. Results of tests
• Abnormalities identified – Go to question 242
• No abnormalities – Go to question 246
Specify cytogenetic abnormalities identified via FISH at last evaluation prior to the start of the preparative regimen / infusion:
242. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: __________________________
243. Specify number of distinct cytogenetic abnormalities
• One (1)
• Two (2)
• Three (3)
• Four or more (4 or more)
244. Specify abnormalities (check all that apply)
Monosomy
• –5
• –7
• –13
• –20
• –Y
Trisomy
• +8
• +19
Translocation
• t(1;3)
• t(2;11)
• t(3;3)
• t(3;21)
• t(6;9)
• t(11;16)
Deletion
• del(3q) / 3q-
• del(5q) / 5q-
• del(7q) / 7q-
• del(9q) / 9q-
• del(11q) / 11q-
• del(12p) / 12p-
• del(13q) / 13q-
• del(20q) / 20q-
Inversion
• inv(3)
Other
• i17q
• Other abnormality – Go to question 245
245. Specify other abnormality:__________________________
246. Was documentation submitted to the CIBMTR? (e.g. FISH report)
• Yes
• No
247. Were cytogenetics tested via karyotyping?
• Yes- Go to question 248
• No- Go to question 254
248. Sample source
• Blood
• Bone marrow
249. Results of tests
• Abnormalities identified – Go to question 250
• No evaluable metaphases- Go to question 254
• No abnormalities – Go to question 254
Specify cytogenetic abnormalities identified via conventional cytogenetics at last evaluation prior to the start of the preparative regimen / infusion:
250. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: __________________________
251. Specify number of distinct cytogenetic abnormalities
• One (1)
• Two (2)
• Three (3)
• Four or more (4 or more)
252. Specify abnormalities (check all that apply)
Monosomy
• –5
• –7
• 13
• –20
• –Y
Trisomy
• +8
• +19
Translocation
• t(1;3)
• t(2;11)
• t(3;3)
• t(3;21)
• t(6;9)
• t(11;16)
Deletion
• del(3q) / 3q-
• del(5q) / 5q-
• del(7q) / 7q-
• del(9q) / 9q-
• del(11q) / 11q-
• del(12p) / 12p-
• del(13q) / 13q-
• del(20q) / 20q-
Inversion
• inv(3)
Other
• i17q
• Other abnormality – Go to question 253
253. Specify other abnormality:__________________________
254. Was documentation submitted to the CIBMTR? (e.g. karyotyping report)
• Yes
• No
Status at transplantation / infusion:
255. What was the disease status?
• Complete remission (CR) –- Go to question 259
• Hematologic improvement (HI) – Go to question 256
• No response (NR) / stable disease (SD) – Go to question 259
• Progression from hematologic improvement (Prog from HI) - Go to question 259
• Relapse from complete remission (Rel from CR) - Go to question 259
• Not assessed - Go to signature line
256. Specify the cell line examined to determine HI status (check all that apply)
• HI-E –- Go to question 257
• HI-P – Go to question 259
• HI-N – Go to question 259
257. Specify transfusion dependence
• Non transfused (NTD)-– Go to question 259
• Low transfusion burden (LTB)- Go to question 259
• High transfusion burden (HTB)- Go to question 258
258. Specify the response achieved
• Major response
• Minor response
259. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___- Go to signature line
YYYY MM DD
Myeloproliferative Neoplasms (MPN)
260. What was the MPN subtype at diagnosis? – If transformed to AML, indicate AML as primary disease; also complete AML Disease Classification questions
• Chronic neutrophilic leukemia (165) –Go to Question 263
• Chronic eosinophilic leukemia, not otherwise specified (NOS) (166) – Go to Question 263
• Essential thrombocythemia (58) – Go to Question 263
• Myeloproliferative neoplasm (MPN), unclassifiable (60) – Go to Question 262
• Myeloid / lymphoid neoplasms with PDGFRA rearrangement (1461) – Go to Question 263
• Myeloid / lymphoid neoplasms with PDGFRB rearrangement (1462) – Go to Question 263
• Myeloid / lymphoid neoplasms with FGFR1 rearrangement (1463) – Go to Question 263
• Myeloid / lymphoid neoplasms with PCM1-JAK2 (1464) – Go to Question 263
• Polycythemia vera (PCV) (57) – Go to Question 263
• Primary myelofibrosis (PMF) (167)- Go to Question 263
Mastocytosis
• Cutaneous mastocytosis (CM) (1465) – Go to Question 263
• Systemic mastocytosis (1470) - Go to Question 261
• Mast cell sarcoma (MCS) (1466) – Go to Question 263
261. Specify Systemic mastocytosis
• Indolent systemic mastocytosis (ISM) – Go to Question 263
• Smoldering systemic mastocytosis (SSM) – Go to Question 263
• Systemic mastocytosis with an associated hematological neoplasm (SM-AHN) – Go to Question 263
• Aggressive systemic mastocytosis (ASM) – Go to Question 263
• Mast cell leukemia (MCL) – Go to Question 263
262. Was documentation submitted to the CIBMTR (e.g. pathology report used for diagnosis)?
• Yes
• No
Assessment at diagnosis
263. Did the recipient have constitutional symptoms (>10% weight loss in 6 months, night sweats, unexplained fever higher than 37.5 °C) in six months before diagnosis?
• Yes
• No
• Unknown
Laboratory studies at diagnosis of MPN:
264. Date CBC drawn: ___ ___ ___ ___ — ___ ___ — ___ ___
YYYY MM DD
265. WBC
• Known – Go to question 266
• Unknown – Go to question 267
266. ___ ___ ___ ___ ___ ___ ● ___ x 109/L (x 103/mm3)
x 106/L
267. Neutrophils
• Known – Go to question 268
• Unknown – Go to question 269
268. ___ ___%
269. Blasts in blood
• Known – Go to question 270
• Unknown– Go to question 271
270. ___ ___ ___ %
271. Hemoglobin
• Known – Go to question 272
• Unknown – Go to question 274
272. ___ ___ ___ ___ ● ___ ___ g/dL
7. g/L
8. mmol/L
273. Were RBCs transfused ≤ 30 days before date of test?
• Yes
• No
274. Platelets
• Known – Go to question 275
• Unknown – Go to question 277
275. ___ ___ ___ ___ ___ ___ ___ x 109/L (x 103/mm3)
x 106/L
276. Were platelets transfused ≤ 7 days before date of test?
• Yes
• No
277. Blasts in bone marrow
• Known – Go to question 278
• Unknown – Go to question 279
278. ___ ___ ___ %
279. Were tests for driver mutations performed?
• Yes – Go to question 280
• No – Go to question 290
• Unknown - Go to question 290
280. JAK2
• Positive– Go to question 281
• Negative– Go to question 283
• Not done– Go to question 283
281. JAK2 V617F
• Positive
• Negative
• Not done
282. JAK2 Exon 12
• Positive
• Negative
• Not done
283. CALR
• Positive – Go to question 284
• Negative– Go to question 287
• Not done– Go to question 287
284. CALR type 1
• Positive
• Negative
• Not done
285. CALR type 2
• Positive
• Negative
• Not done
286. Not defined
• Positive
• Negative
• Not done
287. MPL
• Positive
• Negative
• Not done
288. CSF3R
• Positive
• Negative
• Not done
289. Was documentation submitted to the CIBMTR?
• Yes
• No
290. Were cytogenetics tested (karyotyping or FISH)?
• Yes – Go to question 291
• No – Go to question 307
• Unknown – Go to question 307
291. Were cytogenetics tested via FISH?
• Yes- Go to question 292
• No- Go to question 299
292. Sample source
• Blood
• Bone Marrow
293. Results of tests
• Abnormalities identified – Go to question 294
• No abnormalities – Go to question 298
Specify cytogenetic abnormalities identified via FISH at diagnosis:
294. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: __________________________
295. Specify number of distinct cytogenetic abnormalities
• One (1)
• Two (2)
• Three (3)
• Four or more (4 or more)
296. Specify abnormalities (check all that apply)
Monosomy
• –5
• –7
• –Y
Trisomy
• +8
• +9
Translocation
• t(1;any)
• t(3q21;any)
• t(12p11.2;any)
• t(11q23;any)
• t(6;9)
Deletion
• del(5q) / 5q-
• del(7q) / 7q-
• del(11q) / 11q-
• del(12p) / 12p-
• del(13q) / 13q-
• del(20q) / 20q-
Inversion
• dup(1)
• inv(3)
Other
• i17q
• Other abnormality – Go to question 297
297. Specify other abnormality:__________________________
298. Was documentation submitted to the CIBMTR? (e.g. FISH report)
• Yes
• No
299. Were cytogenetics tested via karyotyping?
• Yes- Go to question 300
• No- Go to question 307
300. Sample source
• Blood
• Bone marrow
301. Results of tests
• Abnormalities identified – Go to question 302
• No evaluable metaphases- Go to question 306
• No abnormalities – Go to question 306
Specify cytogenetic abnormalities identified via conventional cytogenetics at diagnosis:
302. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: __________________________
303. Specify number of distinct cytogenetic abnormalities
• One (1)
• Two (2)
• Three (3)
• Four or more (4 or more)
304. Specify abnormalities (check all that apply)
Monosomy
• –5
• –7
• –Y
Trisomy
• +8
• +9
Translocation
• t(1;any)
• t(3q21;any)
• t(12p11.2;any)
• t(11q23;any)
• t(6;9)
Deletion
• del(5q) / 5q-
• del(7q) / 7q-
• del(11q) / 11q-
• del(12p) / 12p-
• del(13q) / 13q-
• del(20q) / 20q-
Inversion
• dup(1)
• inv(3)
Other
• i17q
• Other abnormality – Go to question 305
305. Specify other abnormality:__________________________
306. Was documentation submitted to the CIBMTR? (e.g. karyotyping report)
• Yes
• No
307. Did the recipient progress or transform to a different MPN subtype or AML between diagnosis and the start of the preparative regimen / infusion?
• Yes – Go to question 308
• No – Go to question 311
308. Specify the MPN subtype or AML after transformation
• Post-essential thrombocythemic myelofibrosis– Go to question 309
• Post-polycythemic myelofibrosis– Go to question 309
• Transformed to AML (70) – Go to question 310
309. Specify the date of the most recent transformation:___ ___ ___ ___ — ___ ___ — ___ ___ - Go to question 311
310. Date of MPN diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___ – Go to signature line
YYYY MM DD
Assessment at last evaluation prior to the start of the preparative regimen/ infusion
311. Specify transfusion dependence at last evaluation prior to the start of the preparative regimen/ infusion
• Non-transfused (NTD) -0 RBCs in 16 wk
• Low-transfusion burden (LTB) -(3-7 RBCs in 16 wk in at least 2 transfusion episodes, maximum 3 in 8 wk)
• High-transfusion burden (HTB) - (≥8 RBCs in 16wk, ≥4 in 8 wk)
312. Did the recipient have constitutional symptoms (>10% weight loss in 6 months, night sweats, unexplained fever higher than 37.5 °C) in six months before last evaluation prior to the start of the preparative regimen / infusion)?
• Yes
• No
• Unknown
313. Did the recipient have splenomegaly at last evaluation prior to the start of the preparative regimen/ infusion?
• Yes – Go to question 314
• No – Go to question 317
• Unknown- Go to question 317
• Not applicable (splenectomy) – Go to question 317
314. Specify the method used to measure spleen size
• Physical assessment- Go to question 315
• Ultrasound- Go to question 316
• CT/ MRI- Go to question 316
315. Specify the spleen size: ___ ___ centimeters below left costal margin
316. Specify the spleen size:___ ___ centimeters
317. Did the recipient have hepatomegaly at last evaluation prior to the start of the preparative regimen/infusion?
• Yes – Go to question 318
• No – Go to question 321
• Unknown – Go to question 321
318. Specify the method used to measure liver size
• Physical assessment- Go to question 319
• Ultrasound- Go to question 320
• CT/ MRI- Go to question 320
319. Specify the liver size: ___ ___ centimeters below right costal margin
320. Specify the liver size: ___ ___ centimeters
Laboratory studies at last evaluation prior to the start of the preparative regimen / infusion:
321. Date CBC drawn: ___ ___ ___ ___ — ___ ___ — ___ ___
YYYY MM DD
322. WBC
• Known – Go to question 323
• Unknown – Go to question 324
323. ___ ___ ___ ___ ___ ___ ● ___ x 109/L (x 103/mm3)
x 106/L
324. Neutrophils
• Known – Go to question 325
• Unknown – Go to question 326
325. ___ ___%
326. Blasts in blood
• Known – Go to question 327
• Unknown– Go to question 328
327. ___ ___ ___ %
328. Hemoglobin
• Known – Go to question 329
• Unknown – Go to question 331
329. ___ ___ ___ ___ ● ___ ___ g/dL
9. g/L
10. mmol/L
330. Were RBCs transfused ≤ 30 days before date of test?
• Yes
• No
331. Platelets
• Known – Go to question 332
• Unknown – Go to question 334
332. ___ ___ ___ ___ ___ ___ ___ x 109/L (x 103/mm3)
x 106/L
333. Were platelets transfused ≤ 7 days before date of test?
• Yes
• No
334. Blasts in bone marrow
• Known – Go to question 335
• Unknown – Go to question 336
335. ___ ___ ___ %
336. Were tests for driver mutations performed?
• Yes – Go to question 337
• No – Go to question 347
• Unknown - Go to question 347
337. JAK2
• Positive– Go to question 338
• Negative– Go to question 340
• Not done– Go to question 340
338. JAK2 V6 17F
• Positive
• Negative
• Not Done
339. JAK2 Exon 12
• Positive
• Negative
• Not done
340. CALR
• Positive – Go to question 341
• Negative– Go to question 344
• Not done– Go to question 344
341. CALR type 1
• Positive
• Negative
• Not done
342. CALR type 2
• Positive
• Negative
• Not done
343. Not defined
• Positive
• Negative
• Not done
344. MPL
• Positive
• Negative
• Not done
345. CSF3R
• Positive
• Negative
• Not done
346. Was documentation submitted to the CIBMTR?
• Yes
• No
347. Were cytogenetics tested (karyotyping or FISH)?
• Yes – Go to question 348
• No – Go to question 364
• Unknown – Go to question 364
348. Were cytogenetics tested via FISH?
• Yes- Go to question 349
• No- Go to question 356
349. Sample source
• Blood
• Bone Marrow
350. Results of tests:
• Abnormalities identified – Go to question 351
• No abnormalities – Go to question 355
Specify cytogenetic abnormalities identified via FISH at last evaluation prior to the start of the preparative regimen / infusion:
351. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: __________________________
352. Specify number of distinct cytogenetic abnormalities:
• One (1)
• Two (2)
• Three (3)
• Four or more (4 or more)
353. Specify abnormalities: (check all that apply)
Monosomy
• –5
• –7
• –Y
Trisomy
• +8
• +9
Translocation
• t(1;any)
• t(3q21;any)
• t(12p11.2;any)
• t(11q23;any)
• t(6;9)
Deletion
• del(5q) / 5q-
• del(7q) / 7q-
• del(11q) / 11q-
• del(12p) / 12p-
• del(13q) / 13q-
• del(20q) / 20q-
Inversion
• dup(1)
• inv(3)
Other
• i17q
• Other abnormality – Go to question 354
354. Specify other abnormality:__________________________
355. Was documentation submitted to the CIBMTR? (e.g. FISH report)
• Yes
• No
356. Were cytogenetics tested via karyotyping?
• Yes- Go to question 357
• No- Go to question 364
357. Sample source
• Blood
• Bone marrow
358. Results of tests
• Abnormalities identified – Go to question 359
• No evaluable metaphases- Go to question 363
• No abnormalities – Go to question 363
Specify cytogenetic abnormalities identified via conventional cytogenetics at last evaluation prior to the start of the preparative regimen / infusion:
359. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: __________________________
360. Specify number of distinct cytogenetic abnormalities
• One (1)
• Two (2)
• Three (3)
• Four or more (4 or more)
361. Specify abnormalities (check all that apply)
Monosomy
• –5
• –7
• –Y
Trisomy
• +8
• +9
Translocation
• t(1;any)
• t(3q21;any)
• t(12p11.2;any)
• t(11q23;any)
• t(6;9)
Deletion
• del(5q) / 5q-
• del(7q) / 7q-
• del(11q) / 11q-
• del(12p) / 12p-
• del(13q) / 13q-
• del(20q) / 20q-
Inversion
• dup(1)
• inv(3)
Other
• i17q
• Other abnormality – Go to question 362
362. Specify other abnormality:__________________________
363. Was documentation submitted to the CIBMTR? (e.g. karyotyping report)
• Yes
• No
Status at transplantation / infusion:
364. What was the disease status?
• Complete clinical remission (CR) - Go to question 368
• Partial clinical remission (PR) –- Go to question 368
• Clinical Improvement (CI) - Go to question 365
• Stable disease (SD)- Go to question 368
• Progressive disease - Go to question 368
• Relapse- Go to question 368
• Not assessed - Go to question 369
365. Was an anemia response achieved?
• Yes
• No
366. Was a spleen response achieved?
• Yes
• No
367. Was a symptom response achieved?
• Yes
• No
368. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___- Go to question 369
YYYY MM DD
369. Specify the cytogenetic response
• Complete response (CR): Eradication of previous abnormality – Go to question 370
• Partial response (PR): ≥ 50% reduction in abnormal metaphases – Go to question 370
• Re-emergence of pre-existing cytogenetic abnormality – Go to question 370
• Not assessed – Go to question 371
• Not applicable – Go to question 371
• None of the above: Does not meet the CR or PR criteria – Go to question 370
370. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___
YYYY MM DD
371. Specify the molecular response
• Complete response (CR): Eradication of pre-existing abnormality – Go to question 372
• PR: ≥50% decrease in allele burden – Go to question 372
• Re-emergence of a pre-existing molecular abnormality – Go to question 372
• Not assessed – Go to First Name
• Not applicable – Go to First Name
• None of the above: Does not meet the CR or PR criteria – Go to 372
372. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___
YYYY MM DD
Other Leukemia (OL)
373. Specify the other leukemia classification:
• Chronic lymphocytic leukemia (CLL), NOS (34) - Go to question 375
• Chronic lymphocytic leukemia (CLL), B-cell / small lymphocytic lymphoma (SLL) (71) - Go to question 375
• Hairy cell leukemia (35) - Go to question 378
• Hairy cell leukemia variant (75) - Go to question 378
• Monoclonal B-cell lymphocytosis (76) – Go to signature line
• Prolymphocytic leukemia (PLL), NOS (37) - Go to question 375
• PLL, B-cell (73) - Go to question 375
• PLL, T-cell (74) - Go to question 375
• Other leukemia, NOS (30) - Go to question 377
• Other leukemia (39) - Go to question 374
374. Specify other leukemia: _________________________________– Go to question 377
375. Was any 17p abnormality detected?
• Yes – If disease classification is CLL, go to question 376. If PLL, go to question 378
• No
376. Did a histologic transformation to diffuse large B-cell lymphoma (Richter syndrome) occur at any time after CLL diagnosis?
• Yes – Go to question 380– Also complete NHL Disease Classification questions
• No – Go to question 378
Status at transplantation / infusion:
377. What was the disease status? (Atypical CML)
• Primary induction failure – Go to question 379
• 1st complete remission (no previous bone marrow or extramedullary relapse) – Go to question 379
• 2nd complete remission – Go to question 379
• ≥ 3rd complete remission – Go to question 379
• 1st relapse – Go to question 379
• 2nd relapse – Go to question 379
• ≥ 3rd relapse – Go to question 379
• No treatment – Go to signature line
378. What was the disease status? (CLL, PLL, Hairy cell leukemia)
• Complete remission (CR) – Go to question 379
• Partial remission (PR) – Go to question 379
• Stable disease (SD) – Go to question 379
• Progressive disease (Prog) – Go to question 379
• Untreated - Go to question 379
• Not assessed - Go to signature line
379. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line
YYYY MM DD
Hodgkin and Non-Hodgkin Lymphoma
380. Specify the lymphoma histology: (at infusion)
Hodgkin Lymphoma Codes
• 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 Codes
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) - Go to question 382
• Diffuse, large B-cell lymphoma- Germinal center B-cell type (1820) - Go to question 382
• 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)
• Extranodal marginal zone B-cell lymphoma of mucosal associated lymphoid tissue type (MALT) (122)
• Follicular, mixed, small cleaved and large cell (Grade II follicle center lymphoma) (103)
• Follicular, predominantly large cell (Grade IIIA follicle center lymphoma) (162)
• Follicular, predominantly large cell (Grade IIIB follicle center lymphoma) (163)
• Follicular, predominantly large cell (Grade IIIA vs IIIB not specified) (1814)
• Follicular, predominantly small cleaved cell (Grade I follicle center lymphoma) (102)
• Follicular (grade unknown) (164)
• HHV8+ DLBCL, NOS (1826)
• High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements (1831)
• High-grade B-cell lymphoma, NOS (1830)
• Intravascular large B-cell lymphoma (136)
• Large B-cell lymphoma with IRF4 rearrangement (1832)
• Lymphomatoid granulomatosis (1835)
• Mantle cell lymphoma (115)
• Nodal marginal zone B-cell lymphoma (± monocytoid B-cells) (123)
• Pediatric nodal marginal zone lymphoma (1813)
• Pediatric-type follicular lymphoma (1816)
• Plasmablastic lymphoma (1836)
• Primary cutaneous DLBCL, leg type (1822)
• Primary cutaneous follicle center lymphoma (1817)
• Primary diffuse, large B-cell lymphoma of the CNS (118)
• Primary effusion lymphoma (138)
• Primary mediastinal (thymic) large B-cell lymphoma (125)
• Splenic B-cell lymphoma/leukemia, unclassifiable (1811)
• Splenic diffuse red pulp small B-cell lymphoma (1812)
• Splenic marginal zone B-cell lymphoma (124)
• T-cell / histiocytic rich large B-cell lymphoma (120)
• Waldenstrom macroglobulinemia / Lymphoplasmacytic lymphoma (173)
• Other B-cell lymphoma (129) – Go to question 381
T-cell and NK-cell Neoplasms
• Adult T-cell lymphoma / leukemia (HTLV1 associated) (134)
• Aggressive NK-cell leukemia (27)
• Anaplastic large-cell lymphoma (ALCL), ALK positive (143)
• Anaplastic large-cell lymphoma (ALCL), ALK negative (144)
• Angioimmunoblastic T-cell lymphoma (131)
• Breast implant–associated anaplastic large-cell lymphoma (1861)
• Chronic lymphoproliferative disorder of NK cells (1856)
• Enteropathy-type T-cell lymphoma (133)
• Extranodal NK / T-cell lymphoma, nasal type (137)
• Follicular T-cell lymphoma (1859)
• Hepatosplenic T-cell lymphoma (145)
• Indolent T-cell lymphoproliferative disorder of the GI tract (1858)
• Monomorphic epitheliotropic intestinal T-cell lymphoma (1857)
• Mycosis fungoides (141)
• Nodal peripheral T-cell lymphoma with TFH phenotype (1860)
• Peripheral T-cell lymphoma (PTCL), NOS (130)
• Primary cutaneous acral CD8+ T-cell lymphoma (1853)
• Primary cutaneous CD4+ small/medium T-cell lymphoproliferative disorder (1854)
• Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma (1852)
• Primary cutaneous CD30+ T-cell lymphoproliferative disorders [Primary cutaneous anaplastic large-cell lymphoma (C-ALCL), lymphoid papulosis] (147)
• Primary cutaneous γδ T-cell lymphoma (1851)
• Sezary syndrome (142)
• Subcutaneous panniculitis-like T-cell lymphoma (146)
• Systemic EBV+ T-cell lymphoma of childhood (1855)
• T-cell large granular lymphocytic leukemia (126)
• Other T-cell / NK-cell lymphoma (139) – Go to question 381
Posttransplant lymphoproliferative disorders (PTLD)
• Classical Hodgkin lymphoma PTLD (1876)
• Florid follicular hyperplasia PTLD (1873)
• Infectious mononucleosis PTLD (1872)
• Monomorphic PTLD (B- and T-/NK-cell types) (1875)
• Plasmacytic hyperplasia PTLD (1871)
• Polymorphic PTLD (1874)
381. Specify other lymphoma histology: ______________________– Go to question 383
382. Assignment of DLBCL (germinal center B-cell type vs. activated B-cell type) subtype was based on:
• Immunohistochemistry (e.g. Han’s algorithm)
• Gene expression profile
• Unknown method
383. Is the lymphoma histology reported at transplant a transformation from CLL?
• Yes – Go to question 384
• No - Go to question 385
384. Was any 17p abnormality detected?
• Yes– Go to question 389
• No– Go to question 389
385. Is the lymphoma histology reported at transplant a transformation from a different lymphoma histology? (Not CLL)
• Yes – Go to question 386
• No – Go to question 389
386. Specify the original lymphoma histology: (prior to transformation) _________________
387. Specify other lymphoma histology:________________
388. Date of original lymphoma diagnosis:___ ___ ___ ___ - ___ ___ - ___ ___ (report the date of diagnosis of original lymphoma subtype)
389. Was a PET (or PET/CT) scan performed? (at last evaluation prior to the start of the preparative regimen / infusion)
• Yes – Go to question 390
• No – Go to question 395
390. Was the PET (or PET/CT) scan positive for lymphoma involvement at any disease site?
• Yes
• No
391. Date of PET scan
• Known– Go to question 392
• Unknown – Go to question 393
392. Date of PET (or PET/CT) scan: ___ ___ ___ ___ — ___ ___ — ___ ___
YYYY MM DD
393. Deauville (five-point) score of the PET (or PET/CT) scan
• Known – Go to question 394
• Unknown – Go to question 395
394. 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
• 5- markedly increased uptake or any new lesion
Status at transplantation / infusion:
395. What was the disease status?
• Disease untreated– Go to signature line
• PIF res - Primary induction failure – resistant: NEVER in COMPLETE remission but with stable or progressive disease on treatment. – Go to question 396
• PIF sen / PR1 - Primary induction failure – sensitive: NEVER in COMPLETE remission but with partial remission on treatment. – Go to question 396
• PIF unk - Primary induction failure – sensitivity unknown– Go to question 396
• CR1 - 1st complete remission: no bone marrow or extramedullary relapse prior to transplant– Go to question 396
• CR2 - 2nd complete remission– Go to question 396
• CR3+ - 3rd or subsequent complete remission– Go to question 396
• REL1 unt - 1st relapse – untreated; includes either bone marrow or extramedullary relapse– Go to question 396
• REL1 res - 1st relapse – resistant: stable or progressive disease with treatment– Go to question 396
• REL1 sen - 1st relapse – sensitive: partial remission (if complete remission was achieved, classify as CR2) – Go to question 396
• REL1 unk - 1st relapse – sensitivity unknown– Go to question 396
• REL2 unt - 2nd relapse – untreated: includes either bone marrow or extramedullary relapse– Go to question 396
• REL2 res - 2nd relapse – resistant: stable or progressive disease with treatment– Go to question 396
• REL2 sen - 2nd relapse – sensitive: partial remission (if complete remission achieved, classify as CR3+)– Go to question 396
• REL2 unk - 2nd relapse – sensitivity unknown– Go to question 396
• REL3+ unt - 3rd or subsequent relapse – untreated; includes either bone marrow or extramedullary relapse– Go to question 396
• REL3+ res - 3rd or subsequent relapse – resistant: stable or progressive disease with treatment– Go to question 396
• REL3+ sen - 3rd or subsequent relapse – sensitive: partial remission (if complete remission achieved, classify as CR3+)– Go to question 396
• REL3+ unk - 3rd relapse or greater – sensitivity unknown– Go to question 396
396. Total number of lines of therapy received: (between diagnosis and HCT / infusion)
• 1 line
• 2 lines
• 3+ lines
397. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line
YYYY MM DD
Multiple Myeloma / Plasma Cell Disorder (PCD)
398. Specify the multiple myeloma/plasma cell disorder (PCD) classification:
• Multiple myeloma (178) – Go to question 400
• Multiple myeloma-light chain only (186) - Go to question 400
• Multiple myeloma-non-secretory (187) - Go to question 406
• Plasma cell leukemia (172) - Go to question 408
• Solitary plasmacytoma (no evidence of myeloma) (175) - Go to question 405
• Smoldering myeloma (180) – Go to question 408
• Amyloidosis (174) - Go to question 401
• Osteosclerotic myeloma / POEMS syndrome (176) - Go to question 408
• Monoclonal gammopathy of renal significance (MGRS) (1611) – Go to question 402
• Other plasma cell disorder (179) - Go to question 399
399. Specify other plasma cell disorder: _________________________ - Go to question 408
400. Specify heavy and/or light chain type: (check all that apply)
• IgG kappa – Go to question 406
• IgA kappa – Go to question 406
• IgM kappa – Go to question 406
• IgD kappa – Go to question 406
• IgE kappa – Go to question 406
• IgG lambda – Go to question 406
• IgA lambda – Go to question 406
• IgM lambda – Go to question 406
• IgD lambda – Go to question 406
• IgE lambda – Go to question 406
• IgG (heavy chain only) – Go to question 406
• IgA (heavy chain only) – Go to question 406
• IgM (heavy chain only) – Go to question 406
• IgD (heavy chain only) – Go to question 406
• IgE (heavy chain only) – Go to question 406
• Kappa (light chain only) – Go to question 406
• Lambda (light chain only) – Go to question 406
401. Specify Amyloidosis classification
• AL amyloidosis – Go to question 408
• AH amyloidosis – Go to question 408
• AHL amyloidosis – Go to question 408
402. Select monoclonal gammopathy of renal significance (MGRS) classification:
• Light chain fanconi syndrome – Go to question 404
• Proximal tubulopathy without crystals – Go to question 404
• Crystal-storing histiocytosis – Go to question 404
• Non-amyloid fibrillary glomerulonephritis – Go to question 404
• Immunotactoid glomerulopathy (ITGN)/ Glomerulonephritis with organized monoclonal microtubular immunoglobulin deposits (GOMMID) – Go to question 404
• Type 1 cryoglobulinemic glomerulonephritis – Go to question 404
• Monoclonal immunoglobulin deposition disease (MIDD) – Go to question 403
• Proliferative glomerulonephritis with monoclonal immunoglobulin G deposits (PGNMID) – Go to question 404
• C3 glomerulopathy with monoclonal gammopathy – Go to question 404
• Unknown – Go to question 404
403. Select monoclonal immunoglobulin deposition disease (MIDD) subtype:
• Light chain deposition disease (LCDD)
• Light and heavy chain deposition disease (LHCDD)
• Heavy chain deposition disease (HCDD)
404. Was documentation submitted to the CIBMTR? (e.g. pathology report)
• Yes – Go to question 408
• No – Go to question 408
405. Solitary plasmacytoma was:
• Extramedullary – Go to question 408
• Bone derived – Go to question 408
406. What was the Durie-Salmon staging (at diagnosis)?
• 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) – Go to question 407
• Stage II (Fitting neither Stage I or Stage III) – Go to question 407
• 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) – Go to question 407
• Unknown – Go to question 408
407. 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)
408. Did the recipient have a preceding or concurrent plasma cell disorder?
• Yes – Go to question 409
• No – Go to question 412
409. Specify preceding / concurrent disorder:
• Multiple myeloma– Go to question 411
• Multiple myeloma-light chain only – Go to question 411
• Multiple myeloma-non-secretory – Go to question 411
• Plasma cell leukemia – Go to question 411
• Solitary plasmacytoma (no evidence of myeloma) – Go to question 411
• Smoldering myeloma – Go to question 411
• Amyloidosis – Go to question 411
• Osteosclerotic myeloma / POEMS syndrome – Go to question 411
• Monoclonal gammopathy of unknown significance (MGUS) – Go to question 411
• Monoclonal gammopathy of renal significance (MGRS) – Go to question 411
• Other plasma cell disorder (PCD) – Go to question 410
410. Specify other preceding/concurrent disorder: ___________________________________
411. Date of diagnosis of preceding / concurrent disorder: ___ ___ ___ ___ — ___ ___ — ___ ___
YYYY MM DD
Copy questions 409- 411 to report more than one concurrent or preceding disorder.
412. Serum β2-microglobulin:
• Known – Go to question 413
• Unknown – Go to question 414
413. Serum β2-microglobulin: ___ ___ ___ ● ___ ___ ___ μg/dL
mg/L
nmol/L
414. Serum albumin:
• Known – Go to question 415
• Unknown – Go to question 416
415. Serum albumin: ___ ___ ● ___ g/dL
g/L
I.S.S. at diagnosis:
416. Stage
• Known – Go to question 417
• Unknown – Go to question 418
417. 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. at diagnosis:
418. Stage
• Known – Go to question 419
• Unknown – Go to question 420
419. Stage
• 1 (ISS stage I and no high-risk cytogenetic abnormalities by FISH and normal LDH levels)
• 2 (Not R-ISS stage I or III)
• 3 (ISS stage III and either high-risk cytogenetic abnormalities by FISH or high LDH levels)
420. Plasma cells in blood by flow cytometry
• Known – Go to question 421
• Unknown – Go to question 423
421. ___ ___%
422. ___ ___ ___ ___ ___ • ___ ___ □ x 109/L (x 103/mm3)
□ x 106/L
423. Plasma cells in blood by morphologic assessment
• Known – Go to question 424
• Unknown – Go to question 426
424. ___ ___%
425. ___ ___ ___ ___ ___ • ___ ___ □ x 109/L (x 103/mm3)
□ x 106/L
426. LDH
• Known – Go to question 427
• Unknown – Go to question 429
427. ___ ___ ___ ___ ___ ● ___ ___ U/L
μkat/L
428. Upper limit of normal for LDH: ___ ___ ___ ___ ___ • ___ ___
Labs at diagnosis
429. Were cytogenetics tested (karyotyping or FISH)? (at diagnosis)
• Yes – Go to question 430
• No – Go to question 442
• Unknown – Go to question 442
430. Were cytogenetics tested via FISH?
• Yes – Go to question 431
• No – Go to question 436
431. Results of tests:
• Abnormalities identified – Go to question 432
• No abnormalities – Go to question 435
Specify cytogenetic abnormalities identified via FISH at diagnosis:
432. International System for Human Cytogenetic Nomenclature (ISCN) compatible string:____________________
433. Specify abnormalities (check all that apply)
Trisomy
• +3
• +5
• +7
• +9
• +11
• +15
• +19
Translocation
• t(4;14)
• t(6;14)
• t(11;14)
• t(14;16)
• t(14;20)
Deletion
• del (13)/13q-
• del (17)/17p-
Monosomy
• - 13
• - 17
Other
• Hyperdiploid (>50)
• Hypodiploid (<46)
• MYC rearrangement
• Any abnormality at 1q
• Any abnormality at 1p
• Other abnormality– Go to question 434
434. Specify other abnormality:_______________________________
435. Was documentation submitted to the CIBMTR? (e.g. FISH report)
• Yes
• No
436. Were cytogenetics tested via karyotyping?
• Yes – Go to question 437
• No – Go to question 442
437. Results of tests
• Abnormalities identified – Go to question 438
• No evaluable metaphases – Go to question 441
• No abnormalities – Go to question 441
Specify cytogenetic abnormalities identified via conventional cytogenetics at diagnosis:
438. International System for Human Cytogenetic Nomenclature (ISCN) compatible string:____________________
439. Specify abnormalities (check all that apply)
Trisomy
• +3
• +5
• +7
• +9
• +11
• +15
• +19
Translocation
• t(4;14)
• t(6;14)
• t(11;14)
• t(14;16)
• t(14;20)
Deletion
• del (13)/13q-
• del (17)/17p-
Monosomy
• - 13
• - 17
Other
• Hyperdiploid (>50)
• Hypodiploid (<46)
• MYC rearrangement
• Any abnormality at 1q
• Any abnormality at 1p
• Other abnormality– Go to question 440
440. Specify other abnormality:________________________________
441. Was documentation submitted to the CIBMTR? (e.g. karyotyping report)
• Yes
• No
Status at transplantation / infusion:
442. What was the disease status?
• Stringent complete response (sCR)
• Complete response (CR)
• Very good partial response (VGPR )
• Partial response (PR)
• No response (NR) / stable disease (SD)
• Progressive disease (PD)
• Relapse from CR (Rel) (untreated)
• Unknown
443. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line
YYYY MM DD
444. Specify amyloidosis hematologic response (for Amyloid patients only)
• Complete response (CR)
• Very good partial response (VGPR)
• Partial response (PR)
• No response (NR) / stable disease (SD)
• Progressive disease (PD)
• Relapse from CR (Rel) (untreated)
• Unknown
445. Date assessed: ___ ___ ___ ___ - ___ ___ - ___ ___ – Go to signature line
YYYY MM DD
Solid Tumors
446. Specify the solid tumor classification:
• Bone sarcoma (excluding Ewing family tumors) (273)
• Breast cancer (250)
• Central nervous system tumor, including CNS PNET (220)
• Cervical (212)
• Colorectal (228)
• Ewing family tumors of bone (including PNET) (275)
• Ewing family tumors, extraosseous (including PNET) (276)
• External genitalia (211)
• Fibrosarcoma (244)
• Gastric (229)
• Germ cell tumor, extragonadal (225)
• Head / neck (201)
• Hemangiosarcoma (246)
• Hepatobiliary (207)
• Leiomyosarcoma (242)
• Liposarcoma (243)
• Lung, non-small cell (203)
• Lung, not otherwise specified (230)
• Lung, small cell (202)
• Lymphangio sarcoma (247)
• Mediastinal neoplasm (204)
• Medulloblastoma (226)
• Melanoma (219)
• Neuroblastoma (222)
• Neurogenic sarcoma (248)
• Ovarian (epithelial) (214)
• Pancreatic (206)
• Prostate (209)
• Renal cell (208)
• Retinoblastoma (223)
• Rhabdomyosarcoma (232)
• Soft tissue sarcoma (excluding Ewing family tumors) (274)
• Synovial sarcoma (245)
• Testicular (210)
• Thymoma (231)
• Uterine (213)
• Vaginal (215)
• Wilm tumor (221)
• Solid tumor, not otherwise specified (200)
• Other solid tumor (269) – Go to question 447
447. Specify other solid tumor: ________________________________- Go to signature line
Severe Aplastic Anemia
448. Specify the severe aplastic anemia classification:
• Acquired severe aplastic anemia, not otherwise specified (301)
• Acquired SAA secondary to hepatitis (302)
• Acquired SAA secondary to toxin / other drug (303)
• Acquired amegakaryocytosis (not congenital) (304)
• Acquired pure red cell aplasia (not congenital) (306)
• Dyskeratosis congenita (307)
• Other acquired cytopenic syndrome (309) – Go to question 449
449. Specify other acquired cytopenic syndrome: __________________________- Go to signature line
Inherited Abnormalities of Erythrocyte Differentiation or Function
450. Specify the inherited abnormalities of erythrocyte differentiation or function classification:
• Paroxysmal nocturnal hemoglobinuria (PNH) (56) – Go to signature line
• Shwachman-Diamond (305) – Go to question 453
• Diamond-Blackfan anemia (pure red cell aplasia) (312) – Go to question 453
• Other constitutional anemia (319) – Go to question 451
• Fanconi anemia (311) (If the recipient developed MDS or AML, indicate MDS or AML as the primary disease). – Go to question 453
• Sickle thalassemia (355) – Go to question 453
• Sickle cell disease (356) – Go to question 453
• Beta thalassemia major (357) – Go to question 453
• Other hemoglobinopathy (359) – Go to question 452
451. Specify other constitutional anemia: ____________________________________- Go to 453
452. Specify other hemoglobinopathy:_______________________________- Go to 453
453. Did the recipient receive gene therapy to treat the inherited abnormalities of erythrocyte differentiation or function?
• Yes - Also complete Cellular Therapy Product and Infusion forms 4003 and 4006. If sickle cell or sickle thalassemia, go to question 454. If beta thalassemia, go to question 457, else go to signature line
• No - If sickle cell or sickle thalassemia, go to question 454. If beta thalassemia, go to question 457, else go to signature line
454. Was tricuspid regurgitant jet velocity (TRJV) measured by Echocardiography pre-HCT? (sickle cell, sickle thalassemia and beta thalassemia major only)
• Yes – Go to question 455
• No– Go to question 457
• Unknown - Go to question 457
455. TRJV measurement:
• Known – Go to question 456
• Unknown– Go to question 457
456. TRJV measurement: __ __ m/sec
457. Was liver iron content (LIC) tested within 6 months prior to infusion? (sickle cell, sickle thalassemia, beta thalassemia major only)
• Yes – Go to question 458
• No – Go to question 460
458. Liver iron content ___ ___ ___ mg iron / g liver dry weight
459. Method used to estimate LIC?
• T2*MRI
• SQUID MRI
• FerriScan
• Liver biopsy
• Other
Beta thalassemia major
460. Is the recipient red blood cell dependent? (requiring transfusion to maintain HGB >7g/dL)
• Yes – Go to question 461
• No – Go to question 468
461. Year of first transfusion (since diagnosis): ___ ___ ___ ___
YYYY
462. Was iron chelation therapy given at any time since diagnosis?
• Yes – Go to question 463
• No – Go to question 468
• Unknown – Go to question 468
463. 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, iron chelation therapy given as specified – 466
• No, iron chelation therapy given, but not meeting criteria – Go to question 464
• Iron chelation therapy given, but details of administration unknown – Go to question 466
464. Specify reason criteria not met
• Non-adherence – Go to question 466
• Toxicity due to iron chelation therapy – Go to question 466
• Other – Go to question 465
465. Specify other reason criteria not met: ______________________
466. Year iron chelation therapy started:
• Known – Go to question 467
• Unknown – Go to question 468
467. Year started: ___ ___ ___ ___
YYYY
468. Did the recipient have hepatomegaly? (> 2 cm below costal margin)
• Yes– Go to question 469
• No– Go to question 470
• Unknown
469. Liver size as measured below the costal margin at most recent evaluation prior to infusion: ___ ___ cm
470. Was a liver biopsy performed at any time since diagnosis?
• Yes – Go to questions 471
• No – Go to questions 477
471. Date assessed
• Known – Go to question 472
• Unknown – Go to question 473
472. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ □ Date estimated
YYYY MM DD
473. Liver cirrhosis:
• Present
• Absent
• Unknown
474. Bridging fibrosis:
• Present
• Absent
• Unknown
475. Chronic hepatitis:
• Present
• Absent
• Unknown
476. Was documentation submitted to the CIBMTR? (e.g., liver biopsy)
• Yes
• No
477. Is there evidence of abnormal cardiac iron deposition based on MRI of the heart at time of infusion?
• Yes
• No
478. Did the recipient have a splenectomy at any time prior to infusion?
• Yes
• No
• Unknown
Laboratory studies at last evaluation prior to start of preparative regimen
479. Serum Iron:
• Known – Go to questions 480
• Unknown – Go to questions 481
480. ___ ___ ___ µg / dL
µmol / L
481. Total iron binding capacity (TIBC):
• Known – Go to question 482
• Unknown – Go to question 483
482. ___ ___ ___ µg / dL
µmol / L
483. Was serum bilirubin less than two times the upper limit of normal?
• Yes
• No
• Unknown
Disorders of the Immune System
484. Specify disorder of immune system classification:
• Adenosine deaminase (ADA) deficiency / severe combined immunodeficiency (SCID) (401) – Go to question 487
• Absence of T and B cells SCID (402) – Go to question 487
• Absence of T, normal B cell SCID (403) – Go to question 487
• Omenn syndrome (404) – Go to question 487
• Reticular dysgenesis (405) – Go to question 487
• Bare lymphocyte syndrome (406) – Go to question 487
• Other SCID (419) – Go to question 485
• SCID, not otherwise specified (410) – Go to question 487
• Ataxia telangiectasia (451) – Go to question 487
• HIV infection (452) – Go to question 487
• DiGeorge anomaly (454) – Go to question 487
• Common variable immunodeficiency (457) – Go to question 487
• Leukocyte adhesion deficiencies, including GP180, CD-18, LFA and WBC adhesion deficiencies (459) – Go to question 487
• Kostmann agranulocytosis (congenital neutropenia) (460) – Go to question 487
• Neutrophil actin deficiency (461) – Go to question 487
• Cartilage-hair hypoplasia (462) – Go to question 487
• CD40 ligand deficiency (464) – Go to question 487
• Other immunodeficiencies (479) – Go to question 486
• Immune deficiency, not otherwise specified (400) – Go to question 487
• Chediak-Higashi syndrome (456) – Also complete Pigmentary Dilution Disorder (PDD) Pre-HCT Data Form – Go to question 487
• Griscelli syndrome type 2 (465) – Also complete Pigmentary Dilution Disorder (PDD) Pre-HCT Data Form – Go to question 487
• Hermansky-Pudlak syndrome type 2 (466) – Also complete Pigmentary Dilution Disorder (PDD) Pre-HCT Data Form – Go to question 487
• Other pigmentary dilution disorder (469) – Also complete Pigmentary Dilution Disorder (PDD) Pre-HCT Data Form – Go to question 487
• Chronic granulomatous disease (455) – Go to question 487
• Wiskott-Aldrich syndrome (453) – Go to question 487
• X-linked lymphoproliferative syndrome (458) – Go to question 487
485. Specify other SCID: ____________________________ – Go to question 487
486. Specify other immunodeficiency: ____________________________– Go to question 487
487. Specify other pigmentary dilution disorder: ____________________________– Go to question 487
488. Did the recipient have an active or recent infection with a viral pathogen within 60 days of HCT?
• Yes– Go to question 489
• No– Go to question 490
489. Specify viral pathogen (check all that apply)
• 304 Adenovirus
• 341 BK Virus
• 344 Coronavirus
• 303 Cytomegalovirus (CMV)
• 347 Chikaugunya Virus
• 346 Dengue Virus
• 325 Enterovirus (ECHO, Coxsackie)
• 327 Enterovirus D68 (EV-D68)
• 326 Enterovirus (polio)
• 328 Enterovirus NOS
• 318 Epstein-Barr Virus (EBV)
• 306 Hepatitis A Virus
• 307 Hepatitis B Virus
• 308 Hepatitis C Virus
• 340 Hepatitis E
• 301 Herpes Simplex Virus (HSV)
• 317 Human herpesvirus 6 (HHV-6)
• 309 Human Immunodeficiency Virus 1 or 2
• 343 Human metapneumovirus
• 322 Human Papillomavirus (HPV)
• 349 Human T-lymphotropic Virus 1 or 2
• 310 Influenza, NOS
• 323 Influenza A Virus
• 324 Influenza B Virus
• 342 JC Virus (Progressive Multifocal Leukoencephalopathy (PML))
• 311 Measles Virus (Rubeola)
• 312 Mumps Virus
• 345 Norovirus
• 316 Human Parainfluenza Virus (all species)
• 314 Respiratory Syncytial Virus (RSV)
• 321 Rhinovirus (all species)
• 320 Rotavirus (all species)
• 315 Rubella Virus
• 302 Varicella Virus
• 348 West Nile Virus (WNV)
490. Has the recipient ever been infected with PCP/PJP?
• Yes
• No
491. Does the recipient have GVHD due to maternal cell engraftment pre-HCT? (SCID only)
• Yes
• No
Inherited Abnormalities of Platelets
492. Specify inherited abnormalities of platelets classification:
Congenital amegakaryocytosis / congenital thrombocytopenia (501)
Glanzmann thrombasthenia (502)
Other inherited platelet abnormality (509) – Go to question 493
493. Specify other inherited platelet abnormality: ________________________________- Go to signature line
Inherited Disorders of Metabolism
494. Specify inherited disorders of metabolism classification:
• Osteopetrosis (malignant infantile osteopetrosis) (521)
Leukodystrophies
• Metachromatic leukodystrophy (MLD) (542)
• Adrenoleukodystrophy (ALD) (543) – Go to question 496
• Krabbe disease (globoid leukodystrophy) (544)
• Lesch-Nyhan (HGPRT deficiency) (522)
• Neuronal ceroid lipofuscinosis (Batten disease) (523)
Mucopolysaccharidoses
• Hurler syndrome (IH) (531)
• Scheie syndrome (IS) (532)
• Hunter syndrome (II) (533)
• Sanfilippo (III) (534)
• Morquio (IV) (535)
• Maroteaux-Lamy (VI) (536)
• β-glucuronidase deficiency (VII) (537)
• Mucopolysaccharidosis (V) (538)
• Mucopolysaccharidosis, not otherwise specified (530)
Mucolipidoses
• Gaucher disease (541)
• Niemann-Pick disease (545)
• I-cell disease (546)
• Wolman disease (547)
• Glucose storage disease (548)
• Mucolipidoses, not otherwise specified (540)
Polysaccharide hydrolase abnormalities
• Aspartyl glucosaminidase (561)
• Fucosidosis (562)
• Mannosidosis (563)
• Polysaccharide hydrolase abnormality, not otherwise specified (560)
• Other inherited metabolic disorder (529) – Go to question 495
• Inherited metabolic disorder, not otherwise specified (520)
495. Specify other inherited metabolic disorder: __________________________ - Go to signature line
496. Loes composite score: __ __ Adrenoleukodystrophy (ALD) only - Go to signature line
Histiocytic disorders
497. Specify histiocytic disorder classification:
Hemophagocytic lymphohistiocytosis (HLH) (571) – Go to question 499
Langerhans cell histiocytosis (histiocytosis-X) (572)
Hemophagocytosis (reactive or viral associated) (573)
Malignant histiocytosis (574)
Other histiocytic disorder (579) – Go to question 498
Histiocytic disorder, not otherwise specified (570)
498. Specify other histiocytic disorder: ____________________________________- Go to signature line
499. Did the recipient have an active or recent infection with a viral pathogen within 60 days of HCT? Hemophagocytic lymphohistiocytosis (HLH) only
• Yes– Go to question 500
• No– Go to question 501
500. Specify viral pathogen (check all that apply)
• 304 Adenovirus
• 341 BK Virus
• 344 Coronavirus
• 303 Cytomegalovirus (CMV)
• 347 Chikaugunya Virus
• 346 Dengue Virus
• 325 Enterovirus (ECHO, Coxsackie)
• 327 Enterovirus D68 (EV-D68)
• 326 Enterovirus (polio)
• 328 Enterovirus NOS
• 318 Epstein-Barr Virus (EBV)
• 306 Hepatitis A Virus
• 307 Hepatitis B Virus
• 308 Hepatitis C Virus
• 340 Hepatitis E
• 301 Herpes Simplex Virus (HSV)
• 317 Human herpesvirus 6 (HHV-6)
• 309 Human Immunodeficiency Virus 1 or 2
• 343 Human metapneumovirus
• 322 Human Papillomavirus (HPV)
• 349 Human T-lymphotropic Virus 1 or 2
• 310 Influenza, NOS
• 323 Influenza A Virus
• 324 Influenza B Virus
• 342 JC Virus (Progressive Multifocal Leukoencephalopathy (PML))
• 311 Measles Virus (Rubeola)
• 312 Mumps Virus
• 345 Norovirus
• 316 Human Parainfluenza Virus (all species)
• 314 Respiratory Syncytial Virus (RSV)
• 321 Rhinovirus (all species)
• 320 Rotavirus (all species)
• 315 Rubella Virus
• 302 Varicella Virus
• 348 West Nile Virus (WNV)
501. Has the recipient ever been infected with PCP/PJP
• Yes- Go to signature line
• No- Go to signature line
Autoimmune Diseases
502. Specify autoimmune disease classification:
Arthritis
• Rheumatoid arthritis (603)
• Psoriatic arthritis / psoriasis (604)
• Juvenile idiopathic arthritis (JIA): systemic (Stills disease) (640)
• Juvenile idiopathic arthritis (JIA): oligoarticular (641)
• Juvenile idiopathic arthritis (JIA): polyarticular (642)
• Juvenile idiopathic arthritis (JIA): other (643)
• Other arthritis (633)
Multiple sclerosis
• Multiple sclerosis (602)
Connective tissue diseases
• Systemic sclerosis (scleroderma) (607)
• Systemic lupus erythematosis (SLE) (605)
• Sjögren syndrome (608)
• Polymyositis / dermatomyositis (606)
• Antiphospholipid syndrome (614)
• Other connective tissue disease (634)
Vasculitis
• Wegener granulomatosis (610)
• Classical polyarteritis nodosa (631)
• Microscopic polyarteritis nodosa (632)
• Churg-Strauss (635)
• Giant cell arteritis (636)
• Takayasu (637)
• Behcet syndrome (638)
• Overlap necrotizing arteritis (639)
• Other vasculitis (611)
Other neurological autoimmune diseases
• Myasthenia gravis (601)
• Other autoimmune neurological disorder (644)
Hematological autoimmune diseases
• Idiopathic thrombocytopenic purpura (ITP) (645)
• Hemolytic anemia (646)
• Evan syndrome (647)
• Other autoimmune cytopenia (648) – Go to question 503
Bowel diseases
• Crohn’s disease (649)
• Ulcerative colitis (650)
• Other autoimmune bowel disorder (651) – Go to question 504
Metabolic
• Diabetes mellitus type 1 (660)
Other
• Other autoimmune disease (629) – Go to question 505
503. Specify other autoimmune cytopenia:_________________________________
504. Specify other autoimmune bowel disorder:_________________________________
505. Specify other autoimmune disease: ____________________
- Go to signature line
Tolerance Induction Associated with Solid Organ Transplant
506. Specify solid organ transplanted: (check all that apply)
• Kidney
• Liver
• Pancreas
• Other organ - Go to question 507
507. Specify other organ: ______________________ - Go to signature line
Other Disease
508. Specify other disease: _________________________________________- Go to signature line
First Name: ____________________________________________________________________________
Last Name:
E-mail address:
Date: ___ ___ ___ ___ — ___ ___ — ___ ___
YYYY MM DD