Draft Pre-TED 2402 - Disease Classification r2

Draft Pre-TED 2402 - Disease Classification r2.pdf

Stem Cell Therapeutic Outcomes Database

Draft Pre-TED 2402 - Disease Classification r2.pdf

OMB: 0915-0310

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Pre-Transplant Essential Data:
Disease Classification

CIBMTR Use Only
Sequence Number:

Date Received:

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

CIBMTR Center Number: ___ ___ ___ ___ ___
CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
Event date: ___ ___ ___ ___ - ___ ___ - ___ ___

HCT type: (check all that apply)

 Autologous
 Allogeneic, unrelated
 Allogeneic, related
Product type: (check all that apply)

 Bone marrow
 PBSC
 Single cord blood unit
 Multiple cord blood units
 Other product
Specify:_____________________________________

CIBMTR Form 2402 revision 21 (page 1 of 77) Draft 34/2319/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Primary Disease for HCT

1.

Date of diagnosis of primary disease for HCT: ___ ___ ___ ___ — ___ ___ — ___ ___
YYYY

2.

MM

DD

What was the primary disease for which the HCT was performed?

 Acute myelogenous leukemia (AML or ANLL) (10) - Go to question 3
 Acute lymphoblastic leukemia (ALL) (20) - Go to question 85
 Acute leukemia of ambiguous lineage and other myeloid neoplasms (80) - Go to question 146
 Chronic myelogenous leukemia (CML) (40) - Go to question 150
 Myelodysplastic (MDS) / myeloproliferative (MPN) diseases (50) (Please classify all preleukemias)
(If recipient has transformed to AML, indicate AML as the primary disease) - Go to question 161



 Other leukemia (30) (includes CLL) - Go to question 255



 Hodgkin lymphoma (150) - Go to question 262



 Non-Hodgkin lymphoma (100) - Go to question 265
 Multiple myeloma / plasma cell disorder (PCD) (170) - Go to question 271
 Solid tumors (200) - Go to question 303
 Severe aplastic anemia (300) (If the recipient developed MDS or AML, indicate MDS or AML as the primary disease)
- Go to question 305

 Inherited abnormalities of erythrocyte differentiation or function (310) - Go to question 307
 Disorders of the immune system (400) - Go to question 310
 Inherited abnormalities of platelets (500) - Go to question 313
 Inherited disorders of metabolism (520) - Go to question 315
 Histiocytic disorders (570) - Go to question 317
 Autoimmune diseases (600) - Go to question 319
 Other disease (900) - Go to question 327

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)
CIBMTR Form 2402 revision 21 (page 2 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 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, minimally differentiated (286)

 AML, not otherwise specified (280)
 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)

3.4. Did AML transform from MDS or MPN?

 Yes – Also complete MDS Disease Classification questions
 No
4.5. Is the disease (AML) therapy related?

 Yes
 No
 Unknown
5.6. Did the recipient have a predisposing condition?

 Yes - Go to question 7
 No - Go to question 9
CIBMTR Form 2402 revision 21 (page 3 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

   Unknown - Go to question 9
6.7. Specify condition:

 Bloom syndrome - Go to question 9
 Down syndrome - Go to question 9
 Fanconi anemia - Go to question 9
 Neurofibromatosis type 1Dyskeratosis congenita - Go to question 9
 Other condition - Go to question 8
7.8. Specify other condition: __________________________________________

CIBMTR Form 2402 revision 21 (page 4 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Labs at diagnosis
9.

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



   Yes - Go to question 10



   No - Go to question 20



   Unknown - Go to question 20
10.

Were cytogenetics tested via FISH?

 Yes – Go to question 11
 No - Go to question 15
11.

Results of tests:

 Abnormalities identified – Go to question 12
 No abnormalities - Go to question 15
Specify cytogenetic abnormalities identified at diagnosis:
12.

Specify number of distinct cytogenetic abnormalities:



One (1)



Three (3)

Two (2)




Four or more (4 or more)
13.

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)

CIBMTR Form 2402 revision 21 (page 5 of 77) Draft 37/236/20176

Commented [EL1]: 1.Add some additional instructions
around how to answer these for patients that had a prior
fanconi, and give examples.
Commented [EL2]: 2.Same format as 2400 Q499
3.
4.Check to see what validations can be done.
Commented [EL3]: 5.For FA patients, clonal
abnormalities come and go. May have gotten several bone
marrow biopsies. Do we really want every abnormality
detected to be reported here?
6.
7.For this question – we’re looking to get abnormalities
detected since the transformation to AML.
8.
9.With how it’s worded, we may be capturing more than
needed for patients with a previous fanconi.

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 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 14
14. Specify other abnormality: _____________________

15.

Were cyteogenetics tested via karyotyping?

 Yes – Go to question 16
 No - Go to question 20
16.

Results of tests:

 Abnormalities identified – Go to question 17
 No evaluable metaphases - Go to question 20
 No abnormalities - Go to question 20
Specify cytogenetic abnormalities identified at diagnosis:
17.



Specify number of distinct cytogenetic abnormalities:

One (1)

CIBMTR Form 2402 revision 21 (page 6 of 77) Draft 37/236/20176

Commented [EL4]: 10.Add some additional instructions
around how to answer these for patients that had a prior
fanconi, and give examples.
Commented [EL5]: 11.Same format as 2400 Q499
12.
13.Check to see what validations can be done.
Commented [EL6]: 14.For FA patients, clonal
abnormalities come and go. May have gotten several bone
marrow biopsies. Do we really want every abnormality
detected to be reported here?
15.
16.For this question – we’re looking to get abnormalities
detected since the transformation to AML.
17.
18.With how it’s worded, we may be capturing more than
needed for patients with a previous fanconi.

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Two (2)





Three (3)
Four or more (4 or more)

18.

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

CIBMTR Form 2402 revision 21 (page 7 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 12p any abnormality


 Other abnormality - Go to question 19
19. Specify other abnormality: _____________________

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



   Yes – Go to question 21



   No – Go to question 31



   Unknown – Go to question 31
Specify molecular markers identified at diagnosis:
21.

CEBPA



 Positive – Go to question 22



 Negative - Go to question 23



 Not done - Go to question 23

23.

22.

Specify CEBPA mutation



 Biallelic (homozygous)



 Monoallelic (heterozygous)



 Unknown

FLT3 – D835 point mutation



 Positive



 Negative



 Not done

24.

FLT3 – ITD mutation



 Positive



 Negative



 Not done

25.

IDH1



 Positive



 Negative



 Not done

26.

IDH2



 Positive



 Negative

CIBMTR Form 2402 revision 21 (page 8 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___


27.

 Not done
KIT



 Positive



 Negative



 Not done

28.

NPM1



 Positive



 Negative



 Not done

29.

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Other molecular marker



 Positive- Go to question 30



 Negative- Go to question 30



 Not done- Go to question 31
30.

Specify other molecular marker: _________________________________

Copy and complete questions 29-30 for multiple molecular markers
Labs at last evaluation prior to the start of the preparative regimen
31.

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



   Yes - Go to question 32



   No - Go to question 42



   Unknown - Go to question 42
32.

Were cyteogenetics tested via FISH?

 Yes – Go to question 33
 No - Go to question 37
33.

Results of tests:

 Abnormalities identified – Go to question 34
 No abnormalities - Go to question 37
Specify cytogenetic abnormalities identified at last evaluation prior to the start of the
preparative regimen:
34.



Specify number of distinct cytogenetic abnormalities:

One (1)

CIBMTR Form 2402 revision 21 (page 9 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Two (2)





Three (3)
Four or more (4 or more)

35.

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

CIBMTR Form 2402 revision 21 (page 10 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 12p any abnormality


 Other abnormality - Go to question 36
36. Specify other abnormality: _____________________

37.

Were cyteogenetics tested via karyotyping?

 Yes – Go to question 38
 No - Go to question 42
38.

Results of tests:

 Abnormalities identified – Go to question 39
 No evaluable metaphases - Go to question 42
 No abnormalities - Go to question 42
Specify cytogenetic abnormalities identified at last evaluation prior to the start of the
preparative regimen:
39.



Specify number of distinct cytogenetic abnormalities:

One (1)
Two (2)






Three (3)
Four or more (4 or more)

40.

Specify abnormalities (check all that apply)



 -5



 -7



 -17



 -18



 -X



 -Y



 +4



 +8



 +11



 +13
 +14
 +21
 +22

CIBMTR Form 2402 revision 21 (page 11 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 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 41
41. Specify other abnormality: _____________________

42.

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



   Yes – Go to question 43



   No – Go to question 55



   Unknown – Go to question 55
Specify molecular markers identified at any time prior to the start of the preparative regimen:
43.

CEBPA



 Positive – Go to question 44



 Negative - Go to question 45



 Not done - Go to question 45
44.

Specify CEBPA mutation

CIBMTR Form 2402 revision 21 (page 12 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

45.



 Biallelic (homozygous)



 Monoallelic (heterozygous)



 Unknown

FLT3 – D835 point mutation



 Positive



 Negative



 Not done

46.

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

FLT3 – ITD mutation



 Positive - Go to question 47



 Negative - Go to question 49



 Not done - Go to question 49
47.

FLT3 – ITD allelic ratio



 Known - Go to question 48



 Unknown - Go to question 49
48. Specify FLT3 - ITD allelic ratio: ___ . ___

49.

IDH1



 Positive



 Negative



 Not done

50.

IDH2



 Positive



 Negative



 Not done

51.

KIT



 Positive



 Negative



 Not done

52.

NPM1



 Positive



 Negative

CIBMTR Form 2402 revision 21 (page 13 of 77) Draft 37/236/20176

Commented [EL7]: 19.0.3-0.7

CIBMTR Center Number: ___ ___ ___ ___ ___


53.

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Not done
Other molecular marker



 Positive- Go to question 54



 Negative- Go to question 54



 Not done- Go to question 55
54.

Specify other molecular marker: _________________________________

Copy and complete questions 53-54 to report multiple other molecular markers
Labs between diagnosis and last evaluation prior to the start of the preparative regimen
55.

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



   Yes - Go to question 56



   No - Go to question 66



   Unknown - Go to question 66
56.

Were cytogenetics tested via FISH?

 Yes – Go to question 57
 No - Go to question 61
57.

Results of tests:

 Abnormalities identified – Go to question 58
 No abnormalities - Go to question 61
Specify cytogenetic abnormalities identified between diagnosis and last evaluation:
58.



Specify number of distinct cytogenetic abnormalities:

One (1)
Two (2)






Three (3)
Four or more (4 or more)

59.

Specify abnormalities (check all that apply)



 -5



 -7



 -17



 -18



 -X

CIBMTR Form 2402 revision 21 (page 14 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___



 -Y



 +4



 +8



 +11



 +13

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 +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 60
60. Specify other abnormality: _____________________

61.

Were cyteogenetics tested via karyotyping?

 Yes – Go to question 62
 No - Go to question 66
62.

Results of tests:

 Abnormalities identified – Go to question 63
CIBMTR Form 2402 revision 21 (page 15 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 No evaluable metaphases - Go to question 66
 No abnormalities - Go to question 66
Specify cytogenetic abnormalities identified between diagnosis and last evaluation:
63.

Specify number of distinct cytogenetic abnormalities:



One (1)



Three (3)

Two (2)




Four or more (4 or more)
64.

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–

CIBMTR Form 2402 revision 21 (page 16 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 del(17q) / 17q–
 del(20q) / 20q–
 del(21q) / 21q–
 inv(3)
 inv(16)
 (11q23) any abnormality
 12p any abnormality


 Other abnormality - Go to question 65
65. Specify other abnormality: _____________________

66.

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



   Yes – Go to question 67



   No – Go to question 79



   Unknown – Go to question 79
Specify molecular markers identified between diagnosis and last evaluation:
67.

CEBPA



 Positive – Go to question 68



 Negative - Go to question 69



 Not done - Go to question 69

69.

68.

Specify CEBPA mutation



 Biallelic (homozygous)



 Monoallelic (heterozygous)



 Unknown

FLT3 – D835 point mutation



 Positive



 Negative



 Not done

70.

FLT3 – ITD mutation



 Positive - Go to question 71



 Negative - Go to question 73



 Not done - Go to question 73

CIBMTR Form 2402 revision 21 (page 17 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

71.

FLT3 – ITD allelic ratio



 Known - Go to question 72



 Unknown - Go to question 73
72. Specify FLT3 - ITD allelic ratio: ___ . ___

73.

IDH1



 Positive



 Negative



 Not done

74.

IDH2



 Positive



 Negative



 Not done

75.

KIT



 Positive



 Negative



 Not done

76.

NPM1



 Positive



 Negative



 Not done

77.

Other molecular marker



 Positive- Go to question 78



 Negative- Go to question 78



 Not done- Go to question 79
78.

Specify other molecular marker: _________________________________

Copy and complete questions 77-78 to report multiple other molecular markers

CNS Leukemia

CIBMTR Form 2402 revision 21 (page 18 of 77) Draft 37/236/20176

Commented [EL8]: 20.0.3-0.7

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

79.

Did the recipient have central nervous system leukemia at any time prior to the start of the preparative regimen /
infusion?



 Yes



 No
 Unknown

8. ________________________________________________________________________________________ Were
cytogenetics tested (karyotyping or FISH)?
3. ________________________________________________________________________________________ 




Yes - Go to question 10
4. ________________________________________________________________________________________ 



 No
- Go to question 47
5. ________________________________________________________________________________________ 




Unknown - Go to question 47
9. ________________________________________________________________________________________ Result
s of tests:
6. ________________________________________________________________________________________
__________________________________________________________________________________________ 
Abnormalities identified – Go to question 11
7. ________________________________________________________________________________________
__________________________________________________________________________________________  No
evaluable metaphases - Go to question 47
8. ________________________________________________________________________________________
__________________________________________________________________________________________  No
abnormalities - Go to question 47
9. ________________________________________________________________________________________ Specif
y cytogenetic abnormalities identified at any time prior to the start of the preparative regimen:
10. _______________________________________________________________________________________ Mono
somy
10. _______________________________________________________________________________________ –5
11. _______________________________________________________________________________________ 




Yes
CIBMTR Form 2402 revision 21 (page 19 of 77) Draft 37/236/20176

Commented [EL9]: 21.Need to clarify that this is
negative lp. If not tested, need to mark UK, Not tested.

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

12. _______________________________________________________________________________________ 





No
11. _______________________________________________________________________________________ –7
13. _______________________________________________________________________________________ 




Yes
14. _______________________________________________________________________________________ 





No
12. _______________________________________________________________________________________ –17
15. _______________________________________________________________________________________ 




Yes
16. _______________________________________________________________________________________ 





No
13. _______________________________________________________________________________________ –18
17. _______________________________________________________________________________________ 




Yes
18. _______________________________________________________________________________________ 





No
14. _______________________________________________________________________________________ –X
19. _______________________________________________________________________________________ 




Yes
20. _______________________________________________________________________________________ 





No
15. _______________________________________________________________________________________ –Y

CIBMTR Form 2402 revision 21 (page 20 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

21. _______________________________________________________________________________________ 




Yes
22. _______________________________________________________________________________________ 





No
23. _______________________________________________________________________________________ Triso
my
16. _______________________________________________________________________________________ +4
24. _______________________________________________________________________________________ 




Yes
25. _______________________________________________________________________________________ 





No
17. _______________________________________________________________________________________ +8
26. _______________________________________________________________________________________ 




Yes
27. _______________________________________________________________________________________ 





No
18. _______________________________________________________________________________________ +11
28. _______________________________________________________________________________________ 




Yes
29. _______________________________________________________________________________________ 





No
19. _______________________________________________________________________________________ +13
30. _______________________________________________________________________________________ 




Yes

CIBMTR Form 2402 revision 21 (page 21 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

31. _______________________________________________________________________________________ 





No
20. _______________________________________________________________________________________ +14
32. _______________________________________________________________________________________ 




Yes
33. _______________________________________________________________________________________ 





No
21. _______________________________________________________________________________________ +21
34. _______________________________________________________________________________________ 




Yes
35. _______________________________________________________________________________________ 





No
22. _______________________________________________________________________________________ +22
36. _______________________________________________________________________________________ 




Yes
37. _______________________________________________________________________________________ 





No
38. _______________________________________________________________________________________ Transl
ocation
23. _______________________________________________________________________________________ t(3;3)
39. _______________________________________________________________________________________ 




Yes
40. _______________________________________________________________________________________ 





No
24. _______________________________________________________________________________________ t(6;9)
CIBMTR Form 2402 revision 21 (page 22 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

41. _______________________________________________________________________________________ 




Yes
42. _______________________________________________________________________________________ 





No
25. _______________________________________________________________________________________ t(8;21)
43. _______________________________________________________________________________________ 




Yes
44. _______________________________________________________________________________________ 





No
26. _______________________________________________________________________________________ t(9;11)
45. _______________________________________________________________________________________ 




Yes
46. _______________________________________________________________________________________ 





No
27. _______________________________________________________________________________________ t(9;22)
47. _______________________________________________________________________________________ 




Yes
48. _______________________________________________________________________________________ 





No
28. _______________________________________________________________________________________ t(15;1
7) and variants
49. _______________________________________________________________________________________ 




Yes
50. _______________________________________________________________________________________ 





No
CIBMTR Form 2402 revision 21 (page 23 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

29. _______________________________________________________________________________________ t(16;1
6)
51. _______________________________________________________________________________________ 




Yes
52. _______________________________________________________________________________________ 





No
53. _______________________________________________________________________________________ Deleti
on
30. _______________________________________________________________________________________ del(3q
) / 3q–
54. _______________________________________________________________________________________ 




Yes
55. _______________________________________________________________________________________ 





No
31. _______________________________________________________________________________________ del(5q
) / 5q–
56. _______________________________________________________________________________________ 




Yes
57. _______________________________________________________________________________________ 





No
32. _______________________________________________________________________________________ del(7q
) / 7q–
58. _______________________________________________________________________________________ 




Yes
59. _______________________________________________________________________________________ 





No

CIBMTR Form 2402 revision 21 (page 24 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

33. _______________________________________________________________________________________ del(9q
) / 9q–
60. _______________________________________________________________________________________ 




Yes
61. _______________________________________________________________________________________ 





No
34. _______________________________________________________________________________________ del(11
q) / 11q–
62. _______________________________________________________________________________________ 




Yes
63. _______________________________________________________________________________________ 





No
35. _______________________________________________________________________________________ del(16
q) / 16q–
64. _______________________________________________________________________________________ 




Yes
65. _______________________________________________________________________________________ 





No
36. _______________________________________________________________________________________ del(17
q) / 17q–
66. _______________________________________________________________________________________ 




Yes
67. _______________________________________________________________________________________ 





No
37. _______________________________________________________________________________________ del(20
q) / 20q–

CIBMTR Form 2402 revision 21 (page 25 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

68. _______________________________________________________________________________________ 




Yes
69. _______________________________________________________________________________________ 





No
38. _______________________________________________________________________________________ del(21
q) / 21q–
70. _______________________________________________________________________________________ 




Yes
71. _______________________________________________________________________________________ 





No
72. _______________________________________________________________________________________ Invers
ion
39. _______________________________________________________________________________________ inv(3)
73. _______________________________________________________________________________________ 




Yes
74. _______________________________________________________________________________________ 





No
40. _______________________________________________________________________________________ inv(16
)
75. _______________________________________________________________________________________ 




Yes
76. _______________________________________________________________________________________ 





No
77. _______________________________________________________________________________________ Other
41. _______________________________________________________________________________________
(11q23) any abnormality
CIBMTR Form 2402 revision 21 (page 26 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

78. _______________________________________________________________________________________ 




Yes
79. _______________________________________________________________________________________ 





No
42. _______________________________________________________________________________________ 12p
any abnormality
80. _______________________________________________________________________________________ 




Yes
81. _______________________________________________________________________________________ 





No
43. _______________________________________________________________________________________ Compl
ex - ≥ 3 distinct abnormalities
82. _______________________________________________________________________________________ 




Yes
83. _______________________________________________________________________________________ 





No
44. _______________________________________________________________________________________ Other
abnormality
84. _______________________________________________________________________________________ 




Yes - Go to question 46
85. _______________________________________________________________________________________ 




No - Go to question 47
45. _______________________________________________________________________________________ Specif
y other abnormality: __________________________________
46. _______________________________________________________________________________________ Were
tests for molecular markers performed (e.g. PCR)?



  Yes – Go to question 48



  No – Go to question 57

CIBMTR Form 2402 revision 21 (page 27 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___



CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

  Unknown – Go to question 57

Specify molecular markers identified at any time prior to the start of the preparative regimen:
47.



CEBPA

 Positive

 Negative
 Not done
48.



FLT3 – D835 point mutation

 Positive

 Negative
 Not done
49.



FLT3 – ITD mutation

 Positive

 Negative
 Not done
50.



IDH1

 Positive

 Negative
 Not done
51.



IDH2

 Positive

 Negative
 Not done
52.



KIT

 Positive

 Negative
 Not done
53.



NPM1

 Positive

 Negative
 Not done

CIBMTR Form 2402 revision 21 (page 28 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

54. _______________________________________________________________________________________ Other
molecular marker



 Positive- Go to question 56

 Negative- Go to question 56
 Not done- Go to question 57
55.

Specify other molecular marker: _________________________________

Status at transplantation:
56.80. ___________________________________________________________________________________ What
was the disease status (based on hematological test results)?

 Primary induction failure – Go to question 84


 1st complete remission (no previous bone marrow or extramedullary relapse) (include CRi and CRp)– Go to



 2nd complete remission – Go to question 81

question 81

 ≥ 3rd complete remission – Go to question 81
 1st relapse – Go to question 83
 2nd relapse – Go to question 83


 ≥ 3rd relapse – Go to question 83



 No treatment – Go to question 84
57.81. How many cycles of induction therapy were required to achieve 1st complete remission? (e CRincludes
CRi, CRp)?



1



2



≥ 3
58.

Was the recipient in molecular remission?

3.

 Yes

4.

 No

5.

 Unknown

6.

 Not applicable

59.82. Was the recipient in remission by flow cytometry?



Yes – Go to question 84



No – Go to question 84



Unknown – Go to question 84



Not applicable – Go to question 84

CIBMTR Form 2402 revision 21 (page 29 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

60.

Was the recipient in cytogenetic remission?

7.

 Yes – Go to question 63

8.

 No – Go to question 63

9.

 Unknown – Go to question 63

10.

 Not applicable– Go to question 63

61.83. Date of most recent relapse: ___ ___ ___ ___ — ___ ___ — ___ ___
YYYY

MM

DD

62.84. ___________________________________________________________________________________ Date
assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line
YYYY

MM

DD

Acute Lymphoblastic Leukemia (ALL)

86.85. 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 (<45 chromosomes) (83)
 B-lymphoblastic leukemia / lymphoma, BCR-ABL1-like (provisional entity) (94)
 B-lymphoblastic leukemia / lymphoma, with iAMP21 (provisional entity) (95)
T-cell lymphoblastic leukemia / lymphoma
 Early T-cell precursor lymphoblastic leukemia (provisional entity) (96)
Natural killer (NK)- cell lymphoblastic leukemia / lymphoma (provisional entity) (97)
86.

Did the recipient have a predisposing condition?

CIBMTR Form 2402 revision 21 (page 30 of 77) Draft 37/236/20176

Commented [EL10]: 22. Divider for paper form only.
Doesn’t need to be in FDM

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Yes - Go to question 66
 No - Go to question 68



 Unknown - Go to question 68
87. Specify condition:

Aplastic anemia - Go to question 68


Bloom syndrome - Go to question 68



Down syndrome - Go to question 68



Fanconi anemia - Go to question 68



Other condition - Go to question 67
87.88.

Also complete CIBMTR Form 2028 — APL

Also complete CIBMTR Form 2029 — FAN

Specify other condition: _______________________________________________________

88.89. Were tyrosine kinase inhibitors (i.e.imatinib mesylate) given for pre-HCT therapy at any time prior to start of the
preparative regimen?

 Yes
 No
Laboratory studies at diagnosis:
90.

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

 Yes - Go to question 70
 No - Go to question 81
 Unknown - Go to question 81
91.

Were cytogenetics tested via FISH? (at diagnosis)



 Yes - Go to question 71





 No - Go to question 75
92. Results of tests: (at diagnosis)





  Abnormalities identified - Go to question 72





  No abnormalities - Go to question 75
Specify cytogenetic abnormalities identified:
93. Specify number of distinct cytogenetic abnormalities:

 One (1)
 Two (2)
 

 Three (3)
 Four or more (4 or more)

CIBMTR Form 2402 revision 21 (page 31 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

94. Specify abnormalities: (check all that apply)

 –7
 +4


 +8



 +21

 +17
 t(1;19)


 t(2;8)



 t(5;14)

 t(4;11)
 t(8;14)


 t(8;22)



 t(10;14)



 t(11;14)



 del(6q) / 6q–



 del(12p) / 12p–



 add(14q)



 9p any abnormality



 Hyperdiploid (> 50)



 Hypodiploid (< 45)

 t(9;22)

 t(12;21)
 del(9p) / 9p–

 (11q23) any abnormality
 12p any abnormality

 Other abnormality – Go to question 74
95. Specify other abnormality: ________________________________________________
96. Were cytogenetics tested via karyotyping? (at diagnosis)

 

Yes - Go to question 76


No - Go to question 80
97.

Results of tests: (at diagnosis)




 Abnormalities identified - Go to question 77




 No evaluable metaphases - Go to question 80




 No abnormalities - Go to question 80

CIBMTR Form 2402 revision 21 (page 32 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Specify cytogenetic abnormalities identified:
98.

Specify number of distinct cytogenetic abnormalities:

 One (1)
 Two (2)


 Three (3)
 Four or more (4 or more)

99.

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 (< 45)
 Other abnormality – Go to question 79
89.100. Specify other abnormality: _________________________

90.

Were cytogenetics tested (karyotyping or FISH)?

 Yes - Go to question 67
CIBMTR Form 2402 revision 21 (page 33 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 No - Go to question 95
 Unknown - Go to question 95
91.

Results of tests:

 Abnormalities identified – Go to question 68
 No evaluable metaphases - Go to question 95
 No abnormalities - Go to question 95
Specify cytogenetic abnormalities identified at any time prior to the start of the preparative
regimen:
Monosomy
92.

–7

 Yes
 No
Trisomy
93.

+4

 Yes
 No
94.

+8

 Yes
 No
95.

+17

 Yes
 No
96.

+21

 Yes
 No
Translocation
97.

t(1;19)

 Yes
 No
CIBMTR Form 2402 revision 21 (page 34 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___
98.

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

t(2;8)

 Yes
 No
99.

t(4;11)

 Yes
 No
100.

t(5;14)

 Yes
 No
101.

t(8;14)

 Yes
 No
102.

t(8;22)

 Yes
 No
103.

t(9;22)

 Yes
 No
104.

t(10;14)

 Yes
 No
105.

t(11;14)

 Yes
 No
106.

t(12;21)

 Yes
 No
Deletion
107.

del(6q) / 6q–

 Yes
CIBMTR Form 2402 revision 21 (page 35 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 No
108.

del(9p) / 9p–

 Yes
 No
109.

del(12p) / 12p–

 Yes
 No
Addition
110.

add(14q)

 Yes
 No
Other
111.

(11q23) any abnormality

 Yes
 No
112.

9p any abnormality

 Yes
 No
113.

12p any abnormality

 Yes
 No
114.

Hyperdiploid (> 50)

 Yes
 No
115.

Hypodiploid (< 46)

 Yes
 No
116.

Complex - ≥3 distinct abnormalities

 Yes
CIBMTR Form 2402 revision 21 (page 36 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 No
117.

Other abnormality

 Yes - Go to question 94
 No - Go to question 95
118.

Specify other abnormality: ___________________________

119.101. __________________________________________________________________________________ Were
tests for molecular markers performed (e.g. PCR)? (at diagnosis)



   Yes – Go to question 96



   No – Go to question 100



   Unknown – Go to question 100
Specify molecular markers identified at diagnosisany time prior to the start of the preparative regimen:
120.102. _____________________________________________________________________________ BCR /
ABL

 Positive


 Negative



 Not done

121.103. _____________________________________________________________________________ TELAML / AML1

 Positive


 Negative



 Not done

122.104. _____________________________________________________________________________ Other
molecular marker

 Positive – Go to question 99
 Negative – Go to question 99


 Not done – Go to question 100

123.105.________________________________________________________________________ Specif
y other molecular marker: _________________________________________________________________
Copy and complete questions 98-99 for additional molecular markers
Laboratory studies at last evaluation prior to the start of the preparative regimen:
106.

Were cytogenetics tested (karyotyping or FISH)? (at last evaluation prior to the start of the preparative regimen)

CIBMTR Form 2402 revision 21 (page 37 of 77) Draft 37/236/20176

Commented [EL11]: 23.Max of 3

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Yes - Go to question 86
 No - Go to question 97
 Unknown - Go to question 97
107.

Were cytogenetics tested via FISH?



  Yes - Go to question 87





  No - Go to question 91
108. Results of tests:

  Abnormalities identified - Go to question 88
  No abnormalities - Go to question 91
Specify cytogenetic abnormalities identified at last evaluation prior to the start of the
preparative regimen:
109.

Specify number of distinct cytogenetic abnormalities:

 One (1)
 Two (2)



 Three (3)
 Four or more (4 or more)

110.

Specify abnormalities: (check all that apply)

 –7
 +4


 +8
 +17



 +21



 t(2;8)

 t(1;19)
 t(4;11)


 t(5;14)



 t(8;22)

 t(8;14)
 t(9;22)


 t(10;14)



 t(11;14)



 del(6q) / 6q–

 t(12;21)
 del(9p) / 9p–
CIBMTR Form 2402 revision 21 (page 38 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___



 del(12p) / 12p–



 add(14q)
 (11q23) any abnormality



 9p any abnormality



 Hyperdiploid (> 50)



 Hypodiploid (< 45)

 12p any abnormality

 Other abnormality – Go to question 90
111.
112.

Specify other abnormality: ________________________________________

Were cytogenetics tested via karyotyping? (at last evaluation prior to the start of the preparative regimen)



Yes - Go to question 92



No - Go to question 97
113.

Results of tests:




  Abnormalities identified - Go to question 93




  No evaluable metaphases - Go to question 97




  No abnormalities - Go to question 97
Specify cytogenetic abnormalities identified at last evaluation prior to the start of the
preparative regimen:
114.

Specify number of distinct cytogenetic abnormalities:

 One (1)


 Two (2)



 Three (3)



 Four or more (4 or more)

115.

Specify abnormalities: (check all that apply)

 –7
 +4
   +8
 +17
   +21
 t(1;19)
   t(2;8)
 t(4;11)
   t(5;14)
CIBMTR Form 2402 revision 21 (page 39 of 77) Draft 37/236/20176

Commented [EL12]: 24. Need to look at this for
analysis.

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 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 (< 45)
 Other abnormality – Go to question 95
116.
117.

Specify other abnormality: __________________________________________

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

  Yes
 No
118.

Were tests for molecular markers performed (e.g. PCR)? (at last evaluation prior to the start of the preparative
regimen)



   Yes – Go to question 98



   No – Go to question 102



   Unknown – Go to question 102
Specify molecular markers identified at last evaluation prior to the start of the preparative regimen:
119.

BCR / ABL

 Positive


 Negative



 Not done

120.

TEL-AML / AML1

 Positive


 Negative

CIBMTR Form 2402 revision 21 (page 40 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___


121.

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Not done
Other molecular marker

 Positive – Go to question 102
 Negative – Go to question 102


 Not done – Go to question 103
122.

Specify other molecular marker: ______________________________________________

Copy and complete questions 100-101 for additional molecular markers
Laboratory studies between diagnosis last evaluation prior to the start of the preparative regimen:
123.

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

 Yes - Go to question 103
 No - Go to question 114
 Unknown - Go to question 114
124.

Were cytogenetics tested via FISH? (between diagnosis and the last evaluation)



 
Yes - Go to question 104






 No - Go to question 108
125.






Results of tests: (between diagnosis and the last evaluation)

 
 Abnormalities identified - Go to question 105
 
 No abnormalities - Go to question 108
Specify cytogenetic abnormalities identified at diagnosis:
126.

Specify number of distinct cytogenetic abnormalities:

 One (1)
  Two (2)
 

  Three (3)
  Four or more (4 or more)

127.

Specify abnormalities: (check all that apply)

 –7
 +4


 +8



 +21

 +17
CIBMTR Form 2402 revision 21 (page 41 of 77) Draft 37/236/20176

Commented [EL13]: 25.Max of 3

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 t(1;19)


 t(2;8)
 t(4;11)



 t(5;14)



 t(8;22)

 t(8;14)
 t(9;22)


 t(10;14)



 t(11;14)



 del(6q) / 6q–



 del(12p) / 12p–



 add(14q)

 t(12;21)
 del(9p) / 9p–

 (11q23) any abnormality


 9p any abnormality



 Hyperdiploid (> 50)



 Hypodiploid (< 45)

 12p any abnormality

 Other abnormality – Go to question 107
128.

Specify other abnormality: ___________________________________________

129. Were cytogenetics tested via karyotyping? (between diagnosis and the last evaluation)



Yes - Go to question 109



No - Go to question 114
130. Results of tests: (between diagnosis and the last evaluation)





 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:
131.

Specify number of distinct cytogenetic abnormalities:

 One (1)
 Two (2)


 Three (3)

CIBMTR Form 2402 revision 21 (page 42 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Four or more (4 or more)
132.

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 (< 45)
 Other abnormality – Go to question 112
133.

Specify other abnormality: __________________________________________

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

 Yes
 No
135.



Were tests for molecular markers performed (e.g. PCR)? (between diagnosis and last evaluation prior to the
start of the preparative regimen)

   Yes – Go to question 115
CIBMTR Form 2402 revision 21 (page 43 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___



   No – Go to question 119



   Unknown – Go to question 119

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Specify molecular markers identified between diagnosis last evaluation prior to the start of the
preparative regimen:
136.

BCR / ABL

 Positive


 Negative



 Not done

137.

TEL-AML / AML1

 Positive


 Negative



 Not done

138.

Other molecular marker

 Positive – Go to question 118
 Negative – Go to question 118


 Not done – Go to question 119
139.

Specify other molecular marker: ______________________________________________

Copy and complete questions 117-118 for additional molecular markers

CNS Leukemia
140. Did the recipient have central nervous system leukemia at any time prior to the start of the preparative regimen?

 Yes
 No
 Unknown
Status at transplantation:
CIBMTR Form 2402 revision 21 (page 44 of 77) Draft 37/236/20176

Commented [EL14]: 26.Max of 3

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

124.141. ___________________________________________________________________________________ What
was the disease status (based on hematological test results)?

Primary induction failure – Go to question 106


 1st complete remission (no previous marrow or extramedullary relapse) – Go to question 101



  2nd complete remission – Go to question 101



  ≥	3rd complete remission – Go to question 101



  1st relapse – Go to question 105

2nd relapse – Go to question 105
≥	3rd relapse – Go to question 105
No treatment – Go to question 106
125.142. _____________________________________________________________________________ How
many cycles of induction therapy were required to achieve 1st complete remissionCR?



1



2



≥ 3

126.

Was the recipient in molecular remission?



Yes



No



Unknown



Not applicable
127.143. _____________________________________________________________________________ Was
the recipient in remission by flow cytometry?



Yes



No



Unknown



Not applicable
128.

Was the recipient in cytogenetic remission?



Yes – Go to question 106



No – Go to question 106



Unknown – Go to question 106



Not applicable – Go to question 106
129.144. _____________________________________________________________________________ Date
of most recent relapse: ___ ___ ___ ___ — ___ ___ — ___ ___
YYYY

CIBMTR Form 2402 revision 21 (page 45 of 77) Draft 37/236/20176

MM

DD

CIBMTR Center Number: ___ ___ ___ ___ ___
130.145.

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Date assessed: ________ ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line
YYYY

MM

DD

Acute Leukemias of Ambiguous Lineage and Other Myeloid Neoplasms

1.

Specify acute leukemias of ambiguous lineage and other myeloid neoplasm classification:

Blastic plasmacytoid dendritic cell neoplasm (296)– Go to question 109


Acute undifferentiated leukemia (31) – Go to question 109

Mixed phenotype acute leukemia (MPAL) with t(9;22)(q34.1;q11.2); BCR-ABL1 (84) – Go to question 109
Mixed phenotype acute leukemia with t(v; 11q23.3); KMT2A rearranged (85) – Go to question 109
Mixed phenotype acute leukemia, B/myeloid, NOS (86) – Go to question 109
Mixed phenotype acute leukemia, T/myeloid, NOS (87) – Go to question 109
 Other acute leukemia of ambiguous lineage or myeloid neoplasm (88) - Go to question 108

2.

Specify other acute leukemia of ambiguous lineage or myeloid neoplasm: ___________________

Status at transplantation:
3.

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
4.

Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line
YYYY

MM

CIBMTR Form 2402 revision 21 (page 46 of 77) Draft 37/236/20176

DD

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Chronic Myelogenous Leukemia (CML)

5.

Was therapy given prior to this HCT?

 Yes - Go to questions 112
 No - Go to question 118
6.

Combination chemotherapy

 Yes
 No
7.

Hydroxyurea (Droxia, Hydrea)

 Yes
 No
8.

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

 Yes
 No
9.

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

 Yes
 No
10.

Other therapy

 Yes - Go to question 117
 No - Go to question 118
11.
12.

Specify other therapy: ______________________________________

What was the disease status?

 Complete hematologic response (CHR) - Go to questions 119
 Chronic phase – Go to question 119
 Accelerated phase - Go to question 120
CIBMTR Form 2402 revision 21 (page 47 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Blast phase - Go to question 120
13.

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)

14.

Number

 1st
 2nd
 3rd or higher
15.

Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line
YYYY

MM

DD

Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases

16. What was the MDS / MPN subtype at diagnosis? – If transformed to AML, indicate AML as primary disease;
also complete AML Disease Classification questions



 Refractory cytopenia with unilineage dysplasia (RCUD) (includes refractory anemia (RA)) (51)



 Refractory anemia with ringed sideroblasts (RARS) (55)



 Refractory anemia with excess blasts-1 (RAEB-1) (61)



 Refractory cytopenia with multilineage dysplasia (RCMD) (64)



 Childhood myelodysplastic syndrome (Refractory cytopenia of childhood (RCC)) (68)



 Myelodysplastic syndrome with isolated del(5q) (5q– syndrome) (66)



 Chronic neutrophilic leukemia (165)



 Essential thrombocythemia (includes primary thrombocytosis, idiopathic thrombocytosis, hemorrhagic

 Refractory anemia with excess blasts-2 (RAEB-2) (62)

 Myelodysplastic syndrome (MDS), unclassifiable (50)
 Chronic eosinophilic leukemia, NOS (166)
thrombocythemia) (58)
CIBMTR Form 2402 revision 21 (page 48 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___



CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Polycythemia vera (PCV) (57)
 Primary myelofibrosis (includes chronic idiopathic myelofibrosis (CIMF), angiogenic myeloid metaplasia
(AMM), myelofibrosis/sclerosis with myeloid metaplasia (MMM), idiopathic myelofibrosis) (167)
 Myeloproliferative neoplasm (MPN), unclassifiable (60)




 Chronic myelomonocytic leukemia (CMMoL) (54)



 Juvenile myelomonocytic leukemia (JMML/JCML) (no evidence of Ph1 or BCR/ABL) (36) – Go to question
167



 Atypical chronic myeloid leukemia, Ph-/bcr/abl- {CML, NOS} (45) - Go to question 220
 Atypical chronic myeloid leukemia, Ph-/bcr unknown {CML, NOS} (46) - Go to question 220
 Atypical chronic myeloid leukemia, Ph unknown/bcr- {CML, NOS} (48) - Go to question 220
 Atypical chronic myeloid leukemia, Ph unknown/bcr unknown {CML, NOS} (49) - Go to question 220



 Myelodysplastic / myeloproliferative neoplasm, unclassifiable (69)

17.

Was the disease (MDS/MPN) therapy related?

 Yes
 No


  Unknown
18.

Did the recipient have a predisposing condition?



 Yes – Go to question 125
 No – Go to question 127



  Unknown – Go to question 127
19.

Specify condition:


  Aplastic anemia – Go to question 127
 Bloom syndrome – Go to question 127

  Down syndrome – Go to question 127

  Fanconi anemia – – Go to question 127
 Other condition – Go to question 126
20.

Specify other condition: ____________________________________________________

Laboratory studies at diagnosis of MDS:
21.

WBC



 Known



 Unknown
22.

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

CIBMTR Form 2402 revision 21 (page 49 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 x 106/L
23.

Hemoglobin



 Known



 Unknown
 g/dL

24.

___ ___ ___ ___ ● ___ ___







 g/L







 mmol/L

25.

Was RBC transfused ≤ 30 days before date of test?




 Yes
 No

26.



Platelets

 Known
 Unknown
27.

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

 x 106/L
28.




Were platelets transfused ≤ 7 days before date of test?

 Yes
 No

29.

Neutrophils



 Known



 Unknown
30.
31.

___ ___%

Blasts in bone marrow

 Known


 Unknown
32.
33.



___ ___ ___ %

Were cytogenetics tested (karyotyping or FISH)?

  Yes – Go to question 140
 No – Go to question 167
CIBMTR Form 2402 revision 21 (page 50 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___



CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

  Unknown – Go to question 167
34.

Results of tests:


  Abnormalities identified – Go to question 141




No evaluable metaphases – Go to question 167
No abnormalities – Go to question 167

Specify abnormalities identified at diagnosis:
35.









Specify number of distinct cytogenetic abnormalities:

 One (1)
 Two (2)




 Three (3)
 Four or more (4 or more)

Monosomy
36.

–5

 Yes
 No
37. –7

 Yes
 No
38. –13

 Yes
 No
39. –20

 Yes
 No
40. –Y

 Yes
 No
Trisomy

CIBMTR Form 2402 revision 21 (page 51 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

41. +8

 Yes
 No
42. +19

 Yes
 No
Translocation
43. t(1;3)

 Yes
 No
44. t(2;11)

 Yes
 No
45. t(3;3)

 Yes
 No
46. t(3;21)

 Yes
 No
47. t(6;9)

 Yes
 No
48. t(11;16)

 Yes
 No
Deletion
49. del(3q) / 3q-

 Yes
 No
50. del(5q) / 5qCIBMTR Form 2402 revision 21 (page 52 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Yes –
 No
51. del(7q) / 7q-

 Yes
 No
52. del(9q) / 9q-

 Yes
 No
53. del(11q) / 11q-

 Yes
 No
54. del(12p) / 12p-

 Yes
 No
55. del(13q) / 13q-

 Yes
 No
56. del(20q) / 20q-

 Yes
 No
Inversion
57. inv(3)

 Yes
 No
Other
58. i17q

 Yes
 No
59. Other abnormality
CIBMTR Form 2402 revision 21 (page 53 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Yes – Go to question 166
 No – Go to question 167
60.

61.

Specify other abnormality: ______________________________________________

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



 

Yes – Go to question 168



 

No – Go to question 171

62.

Specify the MDS / MPN subtype after transformation:



 Refractory cytopenia with unilineage dysplasia (RCUD) (includes refractory anemia (RA)) (51) – Go to
question 169



 Refractory anemia with ringed sideroblasts (RARS) (55) – Go to question 169



 Refractory anemia with excess blasts-1 (RAEB-1) (61) – Go to question 169
 Refractory anemia with excess blasts-2 (RAEB-2) (62) – Go to question 169



 Refractory cytopenia with multilineage dysplasia (RCMD) (64) – Go to question 169



 Childhood myelodysplastic syndrome (Refractory cytopenia of childhood (RCC)) (68) – Go to
question 169



 Myelodysplastic syndrome with isolated del(5q) (5q– syndrome) (66) – Go to question 169
 Myelodysplastic syndrome (MDS), unclassifiable (50) – Go to question 169



 Chronic neutrophilic leukemia (165) – Go to question 169
 Chronic eosinophilic leukemia, NOS (166) – Go to question 169




 Essential thrombocythemia (includes primary thrombocytosis, idiopathic thrombocytosis, hemorrhagic
thrombocythemia) (58) – Go to question 169
 Polycythemia vera (PCV) (57) – Go to question 169
 Primary myelofibrosis (includes chronic idiopathic myelofibrosis (CIMF), angiogenic myeloid
metaplasia (AMM), myelofibrosis/sclerosis with myeloid metaplasia (MMM), idiopathic myelofibrosis) (167)
– Go to question 169



 Myeloproliferative neoplasm (MPN), unclassifiable (60) – Go to question 169



 Chronic myelomonocytic leukemia (CMMoL) (54) – Go to question 169



 Myelodysplastic / myeloproliferative neoplasm, unclassifiable (69) – Go to question 169



 Transformed to AML (70) – Go to question 170
63.

Specify the date of the most recent transformation:___ ___ ___ ___ — ___ ___ — ___ ___ - Go to
question 171

64.

Date of MDS diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___ – Go to signature line

CIBMTR Form 2402 revision 21 (page 54 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Laboratory studies at last evaluation prior to the start of the preparative regimen:
65.

WBC



 Known



 Unknown
66.

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

 x 106/L
67.

Hemoglobin



 Known



 Unknown
68.

___ ___ ___ ___ ● ___ ___







 g/L







 mmol/L

 g/dL

69.

Was RBC transfused ≤ 30 days before date of test?




 Yes
 No

70.



Platelets

 Known
 Unknown
71.

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

 x 106/L
72.




Were platelets transfused ≤ 7 days before date of test?

 Yes
 No

73.

Neutrophils



 Known



 Unknown
74.
75.

___ ___%

Blasts in bone marrow

 Known
CIBMTR Form 2402 revision 21 (page 55 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___



CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Unknown
76.

77.



___ ___ ___ %

Were cytogenetics tested (karyotyping or FISH)?

 Yes – Go to question 184
 No – Go to question 211



 Unknown – Go to question 211
78.

Results of tests:


 Abnormalities identified – Go to question 185
 No evaluable metaphases – Go to question 211

 No abnormalities – Go to question 211

Specify cytogenetic abnormalities identified at last evaluation prior to the start of the preparative
regimen:
79.




Specify number of distinct cytogenetic abnormalities:



 One (1)



 Two (2)
 Three (3)





 Four or more (4 or more)

Monosomy

80.

–5

 Yes
 No
81. –7

 Yes
 No
82. –13

 Yes
 No
83. –20
CIBMTR Form 2402 revision 21 (page 56 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Yes
 No
84. –Y

 Yes
 No
Trisomy

85. +8

 Yes
 No
86. +19

 Yes
 No
Translocation
87. t(1;3)

 Yes
 No
88. t(2;11)

 Yes
 No
89. t(3;3)

 Yes
 No
90. t(3;21)

 Yes
 No
91. t(6;9)

 Yes
 No
92. t(11;16)
CIBMTR Form 2402 revision 21 (page 57 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Yes
 No
Deletion
93. del(3q) / 3q-

 Yes
 No
94. del(5q) / 5q-

 Yes
 No
95. del(7q) / 7q-

 Yes
 No
96. del(9q) / 9q-

 Yes
 No
97. del(11q) / 11q-

 Yes
 No
98. del(12p) / 12p-

 Yes
 No
99. del(13q) / 13q-

 Yes
 No
100. del(20q) / 20q-

 Yes
 No
Inversion
101. inv(3)
CIBMTR Form 2402 revision 21 (page 58 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Yes
 No
Other
102. i17q

 Yes
 No
103. Other abnormality

 Yes – Go to question 210
 No – Go to question 211
104.

Specify other abnormality: ______________________________________________

Status at transplantation:
105.



What was the disease status?



 Complete remission (CR) – requires all of the following, maintained for ≥ 4 weeks: * bone marrow evaluation:
< 5% myeloblasts with normal maturation of all cell lines * peripheral blood evaluation: hemoglobin ≥ 11 g/dL
untransfused and without erythropoietin support; ANC ≥ 1000/mm3 without myeloid growth factor support;
platelets ≥ 100 x 109/L without thrombopoietic support; 0% blasts - Go to question 215



 Hematologic improvement (HI) – requires one measurement of the following, maintained for ≥ 8 weeks
without ongoing cytotoxic therapy; specify which cell line was measured to determine HI response: * HI-E –
hemoglobin increase of ≥ 1.5 g/dL untransfused; for RBC transfusions performed for Hgb ≤ 9.0, reduction in
RBC units transfused in 8 weeks by ≥ 4 units compared to the pre-treatment transfusion number in 8 weeks *
HI-P – for pre-treatment platelet count of > 20 x 109/L, platelet absolute increase of ≥ 30 x 109/L; for pretreatment platelet count of < 20 x 109/L, platelet absolute increase of ≥ 20 x 109/L and ≥ 100% from pretreatment level * HI-N – neutrophil count increase of ≥ 100% from pre-treatment level and an absolute
increase of ≥ 500/mm3 - Go to question 212



 No response (NR) / stable disease (SD) – does not meet the criteria for at least HI, but no evidence of
disease progression - Go to question 215



 Progression from hematologic improvement (Prog from HI) – requires at least one of the following, in the
absence of another explanation (e.g., infection, bleeding, ongoing chemotherapy, etc.): * ≥ 50% reduction
from maximum response levels in granulocytes or platelets * reduction in hemoglobin by ≥ 1.5 g/dL
*transfusion dependence - Go to question 213



 Relapse from complete remission (Rel from CR) – requires at least one of the following: * return to pretreatment bone marrow blast percentage * decrease of ≥ 50% from maximum response levels in
granulocytes or platelets * transfusion dependence, or hemoglobin level ≥ 1.5 g/dL lower than prior to therapy
- Go to question 214
 Not assessed - Go to signature line
106.

Specify the cell line examined to determine HI status:

CIBMTR Form 2402 revision 21 (page 59 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___





HI-E – hemoglobin increase of ≥ 1.5 g/dL untransfused; for RBC transfusions performed for Hgb ≤
9.0, reduction in RBC units transfused in 8 weeks by ≥ 4 units compared to the pre-treatment
transfusion number in 8 weeks - Go to question 215





HI-P – for pre-treatment platelet count of > 20 x 109/L, platelet absolute increase of ≥ 30 x 109/L; for
pre-treatment platelet count of < 20 x 109/L, platelet absolute increase of ≥ 20 x 109/L and ≥ 100%
from pre-treatment level – Go to question 215





HI-N – neutrophil count increase of ≥ 100% from pre-treatment level and an absolute increase of ≥
500/mm3 - Go to question 215

107.

Date of progression: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to question 215
YYYY

108.

DD

Date of relapse: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to question 215
YYYY

109.

MM

Date assessed:

MM

DD

___ ___ ___ ___ — ___ ___ — ___ ___- Go to signature line
YYYY

MM

DD

Other Leukemia (OL)

110.



Specify the other leukemia classification:

 Chronic lymphocytic leukemia (CLL), NOS (34) - Go to question 218
 Chronic lymphocytic leukemia (CLL), B-cell / small lymphocytic lymphoma (SLL) (71) - Go to question 218
 Hairy cell leukemia (35) - Go to question 221
 Hairy cell leukemia variant (75) - Go to question 221
 Monoclonal B-cell lymphocytosis (76) – Go to signature line
 Prolymphocytic leukemia (PLL), NOS (37) - Go to question 218
 PLL, B-cell (73) - Go to question 218
 PLL, T-cell (74) - Go to question 218
 Other leukemia, NOS (30) - Go to question 220



 Other leukemia (39) - Go to question 217
111. Specify other leukemia: _________________________________________ – Go to question 220
112. Was any 17p abnormality detected?

  
Yes – If disease classification is CLL, go to question 219. If PLL, go to question 221.
   No

CIBMTR Form 2402 revision 21 (page 60 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

113. Did a histologic transformation to diffuse large B-cell lymphoma (Richter syndrome) occur at any time after
CLL diagnosis?

  
Yes – Go to question 226– Also complete NHL Disease Classification questions
   No – Go to question 221


Status at transplantation:
114. What was the disease status? (Atypical CML)

 Primary induction failure – Go to question 222

 1st complete remission (no previous bone marrow or extramedullary relapse) – Go to question 222

 2nd complete remission – Go to question 222

 ≥ 3rd complete remission – Go to question 222

 1st relapse – Go to question 222

 2nd relapse – Go to question 222

 ≥ 3rd relapse – Go to question 222

 No treatment – Go to signature line
115. What was the disease status? (CLL, PLL, Hairy cell leukemia)


  Complete remission (CR) – Go to question 222

  Partial remission (PR) – Go to question 222

  Stable disease (SD) – Go to question 222

  Progressive disease (Prog) – Go to question 222

  Untreated - Go to question 222

  Not assessed - Go to signature line
116.

Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line
YYYY

MM

DD

Hodgkin Lymphoma

117.

Specify Hodgkin lymphoma classification:

 Nodular lymphocyte predominant Hodgkin lymphoma (155)
 Lymphocyte-rich (151)
 Nodular sclerosis (152)
 Mixed cellularity (153)
 Lymphocyte depleted (154)
CIBMTR Form 2402 revision 21 (page 61 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Hodgkin lymphoma, NOS (150)
Status at transplantation:
118.

What was the disease status?

Disease untreated
PIF res - Primary induction failure – resistant: NEVER in COMPLETE remission but with stable or
progressive disease on treatment.



PIF sen / PR1 - Primary induction failure – sensitive: NEVER in COMPLETE remission but with partial
remission on treatment.

PIF unk - Primary induction failure – sensitivity unknown
CR1 - 1st complete remission: no bone marrow or extramedullary relapse prior to transplant
CR2 - 2nd complete remission

CR3+ - 3rd or subsequent complete remission
REL1 unt - 1st relapse – untreated; includes either bone marrow or extramedullary relapse
REL1 res - 1st relapse – resistant: stable or progressive disease with treatment
REL1 sen - 1st relapse – sensitive: partial remission (if complete remission was achieved, classify as CR2)
REL1 unk - 1st relapse – sensitivity unknown
REL2 unt - 2nd relapse – untreated: includes either bone marrow or extramedullary relapse
REL2 res - 2nd relapse – resistant: stable or progressive disease with treatment
REL2 sen - 2nd relapse – sensitive: partial remission (if complete remission achieved, classify as CR3+)
REL2 unk - 2nd relapse – sensitivity unknown

REL3+ unt - 3rd or subsequent relapse – untreated; includes either bone marrow or extramedullary relapse
REL3+ res - 3rd or subsequent relapse – resistant: stable or progressive disease with treatment
REL3+ sen - 3rd or subsequent relapse – sensitive: partial remission (if complete remission achieved,
classify as CR3+)

REL3+ unk - 3rd relapse or greater – sensitivity unknown
119.

Date assessed: ___ ___ ___ ___ - ___ ___ - ___ ___ - Go to signature line
YYYY

MM

DD

Non-Hodgkin Lymphoma

120.

Specify Non-Hodgkin lymphoma classification:

 Splenic marginal zone B-cell lymphoma (124)
 Extranodal marginal zone B-cell lymphoma of mucosal associated lymphoid tissue type (MALT) (122)
CIBMTR Form 2402 revision 21 (page 62 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Nodal marginal zone B-cell lymphoma (± monocytoid B-cells) (123)
 Follicular, predominantly small cleaved cell (Grade I follicle center lymphoma) (102)
 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 (grade unknown) (164)
 Mantle cell lymphoma (115)
 Intravascular large B-cell lymphoma (136)
 Primary mediastinal (thymic) large B-cell lymphoma (125)
 Primary effusion lymphoma (138)
 Diffuse, large B-cell lymphoma — NOS (107)
 Burkitt lymphoma (111)
 B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and Burkitt lymphoma (140)
 B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin
Lymphoma (149)
 T-cell / histiocytic rich large B-cell lymphoma (120)
 Primary diffuse large B-cell lymphoma of the CNS (118)
 Waldenstrom macroglobulinemia / Lymphoplasmacytic lymphoma (173)
 Other B-cell lymphoma (129) – Go to question 227
 Extranodal NK / T-cell lymphoma, nasal type (137)
 Enteropathy-type T-cell lymphoma (133)
 Hepatosplenic T-cell lymphoma (145)
 Subcutaneous panniculitis-like T-cell lymphoma (146)
 Mycosis fungoides (141)
 Sezary syndrome (142)
 Primary cutaneous CD30+ T-cell lymphoproliferative disorders [Primary cutaneous anaplastic large-cell
lymphoma (C-ALCL), lymphoid papulosis] (147)

 Peripheral T-cell lymphoma (PTCL), NOS (130)
 Angioimmunoblastic T-cell lymphoma (131)
 Anaplastic large-cell lymphoma (ALCL), ALK positive (143)
 Anaplastic large-cell lymphoma (ALCL), ALK negative (144)
 T-cell large granular lymphocytic leukemia (126)
 Aggressive NK-cell leukemia (27)
 Adult T-cell lymphoma / leukemia (HTLV1 associated) (134)




 Other T-cell / NK-cell lymphoma (139) – Go to question 227
121. Specify other lymphoma: _________________________________________________________

122.

Is the non-Hodgkin lymphoma histology reported at diagnosis a transformation from CLL?

CIBMTR Form 2402 revision 21 (page 63 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Yes – Go to question 230- Also complete CLL Disease Classification questions
 No - Go to question 229
123. Is the non-Hodgkin lymphoma histology reported a transformation from, or was it diagnosed at the same
time as another lymphoma (not CLL)?

  Yes
 No
Status at transplantation:
124.

What was the disease status?

Disease untreated
PIF res - Primary induction failure – resistant: NEVER in COMPLETE remission but with stable or
progressive disease on treatment.



PIF sen / PR1 - Primary induction failure – sensitive: NEVER in COMPLETE remission but with partial
remission on treatment.

PIF unk - Primary induction failure – sensitivity unknown
CR1 - 1st complete remission: no bone marrow or extramedullary relapse prior to transplant
CR2 - 2nd complete remission

CR3+ - 3rd or subsequent complete remission
REL1 unt - 1st relapse – untreated; includes either bone marrow or extramedullary relapse
REL1 res - 1st relapse – resistant: stable or progressive disease with treatment
REL1 sen - 1st relapse – sensitive: partial remission (if complete remission was achieved, classify as CR2)
REL1 unk - 1st relapse – sensitivity unknown
REL2 unt - 2nd relapse – untreated: includes either bone marrow or extramedullary relapse
REL2 res - 2nd relapse – resistant: stable or progressive disease with treatment
REL2 sen - 2nd relapse – sensitive: partial remission (if complete remission achieved, classify as CR3+)
REL2 unk - 2nd relapse – sensitivity unknown

REL3+ unt - 3rd or subsequent relapse – untreated; includes either bone marrow or extramedullary relapse
REL3+ res - 3rd or subsequent relapse – resistant: stable or progressive disease with treatment
REL3+ sen - 3rd or subsequent relapse – sensitive: partial remission (if complete remission achieved,
classify as CR3+)

REL3+ unk - 3rd relapse or greater – sensitivity unknown
125.

Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line
YYYY

MM

CIBMTR Form 2402 revision 21 (page 64 of 77) Draft 37/236/20176

DD

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Multiple Myeloma / Plasma Cell Disorder (PCD)

126.

Specify the multiple myeloma/plasma cell disorder (PCD) classification:

 Multiple myeloma-lgG (181) - Go to questions 234
 Multiple myeloma-lgA (182) - Go to questions 234
 Multiple myeloma-lgD (183) - Go to questions 234
 Multiple myeloma-lgE (184) - Go to questions 234
 Multiple myeloma-lgM (not Waldenstrom macroglobulinemia) (185) - Go to questions 234
 Multiple myeloma-light chain only (186) - Go to questions 234
 Multiple myeloma-non-secretory (187) - Go to questions 235
 Plasma cell leukemia (172) - Go to question 240
 Solitary plasmacytoma (no evidence of myeloma) (175) - Go to question 240
 Amyloidosis (174) - Go to question 240


 Osteosclerotic myeloma / POEMS syndrome (176) - Go to questions 240



 Light chain deposition disease (177) - Go to questions 240
 Other plasma cell disorder (179) - Go to question 233
127. Specify other plasma cell disorder: _________________________________ - Go to question 240
128.

Light chain

 kappa
 lambda
129. 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
questions 236

 Stage II (Fitting neither Stage I or Stage III) – Go to questions 236
 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 questions 236
 Unknown – Go to questions 237

 

130. 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)
I.S.S.:
CIBMTR Form 2402 revision 21 (page 65 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___
131.

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Serum β2-microglobulin: ___ ___ ___ ● ___ ___ ___

 μg/dL
 mg/L
 nmol/L

132.

Serum albumin: ___ ___ ● ___

 g/dL
 g/L

133. Stage

 1 (β2-mic < 3.5, S. albumin ≥ 3.5)
 2 (β2-mic 3.5–< 5.5, S. albumin —)
 3 (β2-mic ≥ 5.5; S. albumin —)

134.

Were cytogenetics tested (karyotyping or FISH)?

 Yes – Go to questions 241
 No – Go to question 262
 Unknown – Go to question 262

135. Results of tests:

 Abnormalities identified – Go to question 242

 No evaluable metaphases – Go to question 262

 No abnormalities – Go to question 262
Specify cytogenetic abnormalities identified at any time prior to the start of the preparative
regimen:
Trisomy

136. +3



  Yes




  No

137. +5



  Yes




  No

138. +7



  Yes




  No

139. +9
CIBMTR Form 2402 revision 21 (page 66 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___



  Yes




  No

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

140. +11



  Yes




  No

141. +15



  Yes




  No

142. +19



  Yes




  No
Translocation

143. t(4;14)


  Yes



  No

144.

t(6;14)



  Yes



  No

145. t(11;14)



  Yes


No

146. t(14;16)


  Yes



  No
147. t(14;20)



  Yes



  No
Deletion

148. del (13)/13qCIBMTR Form 2402 revision 21 (page 67 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___


  Yes



  No

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

149. del (17)/17p

  Yes



  No
Other

150. Hyperdiploid (>50)


 
 Yes



 
 No

151. Hypodiploid (<46)


  Yes



  No

152. Any abnormality at 1q


  Yes



  No

153. Any abnormality at 1p


  Yes



  No

154. Other abnormality


  Yes



  No
155. Specify other abnormality:______________________________________________

Status at transplantation:
156.

What was the disease status?
 Stringent complete remission (sCR). - CR as defined, plus: normal free light chain ratio, and absence of
clonal cells in the bone marrow by immunohistochemistry or immunofluorescence (confirmation with repeat bone
marrow biopsy not needed). (Presence and/or absence of clonal cells is based upon the κ/λ ratio. An abnormal
κ/λ ratio by immunohistochemistry and/or immunofluorescence requires a minimum of 100 plasma cells for
analysis. An abnormal ratio reflecting the presence of an abnormal clone is κ/λ of > 4:1 or < 1:2.) sCR requires
two consecutive assessments made at any time before the institution of any new therapy, and no known
evidence of progressive or new bone lesions if radiographic studies were performed; radiographic studies are
not required to satisfy sCR requirements. - Go to question 263

CIBMTR Form 2402 revision 21 (page 68 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Complete remission (CR) — negative immunofixation on serum and urine samples, and disappearance of
any soft tissue plasmacytomas, and < 5% plasma cells in the bone marrow (confirmation with repeat bone
marrow biopsy not needed). CR requires two consecutive assessments made at any time before the institution
of any new therapy, and no known evidence of progressive or new bone lesions if radiographic studies were
performed; radiographic studies are not required to satisfy CR requirements. - Go to question 263
 Near complete remission (nCR) — serum and urine M-protein detectable by immunoelectrophoresis (IFE),
but not on electrophoresis (negative SPEP & UPEP); < 5% plasma cells in bone marrow. nCR requires two
consecutive assessments made at any time before the initiation of any new therapy, and no known evidence of
progressive or new bone lesions if radiographic studies were performed; radiographic studies are not required to
satisfy nCR requirements. - Go to question 263
 Very good partial remission (VGPR ) — serum and urine M-protein detectable by immunofixation but not on
electrophoresis, or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours. VGPR
requires two consecutive assessments made at any time before the institution of any new therapy, and no
known evidence of progressive or new bone lesions if radiographic studies were performed; radiographic studies
are not required to satisfy VGPR requirements. - Go to question 263
 Partial remission (PR) — ≥ 50% reduction in serum M-protein, and reduction in 24-hour urinary M-protein by
≥ 90% or to < 200 mg/24 hours. If the serum and urine M-protein are unmeasurable (i.e., do not meet any of the
following criteria: • serum M-protein ≥ 1 g/dL. Urine M-protein ≥ 200 mg/24 hours • serum free light chain assay
shows involved level ≥ 10 mg/dL, provided serum free light chain ratio is abnormal), a ≥ 50% decrease in the
difference between involved and uninvolved free light chain levels is required in place of the M-protein criteria. If
serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, a ≥ 50%
reduction in plasma cells is required in place of M-protein, provided the baseline bone marrow plasma cell
percentage was ≥ 30%. In addition to the above listed criteria, a ≥ 50% reduction in the size of soft tissue
plasmacytomas is also required, if present at baseline. PR requires two consecutive assessments made at any
time before the institution of any new therapy, and no known evidence of progressive or new bone lesions if
radiographic studies were performed; radiographic studies are not required to satisfy PR requirements. - Go to
question 263
 Stable disease (SD) — not meeting the criteria for CR, VGPR, PR or PD. SD requires two consecutive
assessments made at any time before the institution of any new therapy, and no known evidence of progressive
or new bone lesions if radiographic studies were performed; radiographic studies are not required to satisfy SD
requirements. - Go to question 263
 Progressive disease (PD) — requires any one or more of the following: Increase of ≥ 25% from baseline in:
serum M-component and/or (absolute increase ≥ 0.5 g/dL) (for progressive disease, serum M-component
increases of ≥ 1 g/dL are sufficient to define relapse if the starting M-component is ≥ 5 g/dL). Urine Mcomponent and/or (absolute increase ≥ 200 mg/24 hours) for recipients without measurable serum and urine Mprotein levels: the difference between involved and uninvolved free light chain levels (absolute increase > 10
mg/dL). Bone marrow plasma cell percentage (absolute percentage ≥ 10%) (relapse from CR has a 5% cutoff
vs. 10% for other categories of relapse) definite development of new bone lesions or soft tissue plasmacytomas,
or definite increase in the size of any existing bone lesions or soft tissue plasmacytomas. Development of
hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol) that can be attributed solely to the plasma
cell proliferative disorder PD requires two consecutive assessments made at any time before classification as
disease progression, and/or the institution of any new therapy - Go to question 263
 Relapse from CR (Rel) (untreated) — requires one or more of the following: reappearance of serum or urine
M-protein by immunofixation or electrophoresis development of ≥ 5% plasma cells in the bone marrow (relapse
from CR has a 5% cutoff vs. 10% for other categories of relapse) appearance of any other sign of progression
(e.g., new plasmacytoma, lytic bone lesion, hypercalcemia) Rel requires two consecutive assessments made at
any time before classification as relapse, and/or the institution of any new therapy. – Go to question 263


 Unknown – Go to signature line



 Not applicable (Amyloidosis with no evidence of myeloma) – Go to signature line
157.

Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line

CIBMTR Form 2402 revision 21 (page 69 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___
YYYY

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
MM

DD

Solid Tumors

158.

Specify the solid tumor classification:

Breast cancer (250)
Lung, small cell (202)
 Lung, non-small cell (203)
 Lung, not otherwise specified (230)
 Germ cell tumor, extragonadal (225)
 Testicular (210)
 Ovarian (epithelial) (214)
 Bone sarcoma (excluding Ewing family tumors) (273)
 Ewing family tumors of bone (including PNET) (275)
 Ewing family tumors, extraosseous (including PNET) (276)
 Fibrosarcoma (244)
 Hemangiosarcoma (246)
 Leiomyosarcoma (242)
 Liposarcoma (243)
 Lymphangio sarcoma (247)
 Neurogenic sarcoma (248)
 Rhabdomyosarcoma (232)
 Synovial sarcoma (245)
 Soft tissue sarcoma (excluding Ewing family tumors) (274)
 Central nervous system tumor, including CNS PNET (220)
 Medulloblastoma (226)
 Neuroblastoma (222)
 Head / neck (201)
 Mediastinal neoplasm (204)
 Colorectal (228)
 Gastric (229)
 Pancreatic (206)
 Hepatobiliary (207)
CIBMTR Form 2402 revision 21 (page 70 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Prostate (209)
 External genitalia (211)
 Cervical (212)
 Uterine (213)
 Vaginal (215)
 Melanoma (219)
 Wilm tumor (221)
 Retinoblastoma (223)
 Thymoma (231)
 Renal cell (208)
 Other solid tumor (270) – Go to question 265
 Solid tumor, not otherwise specified (200)
159.

Specify other solid tumor: ___________________________________

- Go to signature line

Severe Aplastic Anemia

160.

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 267
161.

Specify other acquired cytopenic syndrome: _______________________________

- Go to signature line

Inherited Abnormalities of Erythrocyte Differentiation or Function

162.

Specify the inherited abnormalities of erythrocyte differentiation or function classification:

CIBMTR Form 2402 revision 21 (page 71 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___



CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Paroxysmal nocturnal hemoglobinuria (PNH) (56)
 Shwachman-Diamond (305)
 Diamond-Blackfan anemia (pure red cell aplasia) (312)
 Other constitutional anemia (319) – Go to question 269
 Fanconi anemia (311) (If the recipient developed MDS or AML, indicate MDS or AML as the primary disease).
 Sickle thalassemia (355)
 Sickle cell disease (356)
 Beta thalassemia major (357)
 Other hemoglobinopathy (359) – Go to question 270
163.

Specify other constitutional anemia: ____________________________________

164.

Specify other hemoglobinopathy:__________________________________

- Go to signature line

Disorders of the Immune System

165.

Specify disorder of immune system classification:

 Adenosine deaminase (ADA) deficiency / severe combined immunodeficiency (SCID) (401)
 Absence of T and B cells SCID (402)
 Absence of T, normal B cell SCID (403)
 Omenn syndrome (404)
 Reticular dysgenesis (405)
 Bare lymphocyte syndrome (406)
 Other SCID (419) – Go to question 272
 SCID, not otherwise specified (410)
 Ataxia telangiectasia (451)
 HIV infection (452)
 DiGeorge anomaly (454)
 Common variable immunodeficiency (457)
 Leukocyte adhesion deficiencies, including GP180, CD-18, LFA and WBC adhesion deficiencies (459)
 Kostmann agranulocytosis (congenital neutropenia) (460)
 Neutrophil actin deficiency (461)
CIBMTR Form 2402 revision 21 (page 72 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Cartilage-hair hypoplasia (462)
 CD40 ligand deficiency (464)
 Other immunodeficiencies (479) – Go to question 273
 Immune deficiency, not otherwise specified (400)
 Chediak-Higashi syndrome (456)
 Griscelli syndrome type 2 (465)


 Hermansky-Pudlak syndrome type 2 (466)
 Chronic granulomatous disease (455)
 Wiskott-Aldrich syndrome (453)
 X-linked lymphoproliferative syndrome (458)
166.

Specify other SCID: ____________________________

167.

Specify other immunodeficiency: ____________________________

- Go to signature line

Inherited Abnormalities of Platelets

168.

Specify inherited abnormalities of platelets classification:

 Congenital amegakaryocytosis / congenital thrombocytopenia (501)
 Glanzmann thrombasthenia (502)
 Other inherited platelet abnormality (509) – Go to question 275
169.

Specify other inherited platelet abnormality: ___________________________________

- Go to signature line

Inherited Disorders of Metabolism

170.

Specify inherited disorders of metabolism classification:

 Osteopetrosis (malignant infantile osteopetrosis) (521)
Leukodystrophies

 Metachromatic leukodystrophy (MLD) (542)
 Adrenoleukodystrophy (ALD) (543)
CIBMTR Form 2402 revision 21 (page 73 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 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 277
 Inherited metabolic disorder, not otherwise specified (520)
171.

Specify other inherited metabolic disorder: ___________________________________

- Go to signature line

Histiocytic disorders

172.

Specify histiocytic disorder classification:

CIBMTR Form 2402 revision 21 (page 74 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Hemophagocytic lymphohistiocytosis (HLH) (571)
 Langerhans cell histiocytosis (histiocytosis-X) (572)
 Hemophagocytosis (reactive or viral associated) (573)
 Malignant histiocytosis (574)
 Other histiocytic disorder (579) – Go to question 279
 Histiocytic disorder, not otherwise specified (570)
173.

Specify other histiocytic disorder: ________________________________________

- Go to signature line

Autoimmune Diseases

174.

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) Go to question 282
 Other arthritis (633) – Go to question 281
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) – Go to question 283
Vasculitis

 Wegener granulomatosis (610)
 Classical polyarteritis nodosa (631)
 Microscopic polyarteritis nodosa (632)
CIBMTR Form 2402 revision 21 (page 75 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

 Churg-Strauss (635)
 Giant cell arteritis (636)
 Takayasu (637)
 Behcet syndrome (638)
 Overlap necrotizing arteritis (639)
 Other vasculitis (611) – Go to question 284
Other neurological autoimmune diseases

 Myasthenia gravis (601)
 Other autoimmune neurological disorder (644) – Go to question 285
Hematological autoimmune diseases

 Idiopathic thrombocytopenic purpura (ITP) (645)
 Hemolytic anemia (646)
 Evan syndrome (647)
 Other autoimmune cytopenia (648) – Go to question 286
Bowel diseases

 Crohn’s disease (649)
 Ulcerative colitis (650)
 Other autoimmune bowel disorder (651) – Go to question 287
175.

Specify other arthritis:_________________________________

176.

Specify other juvenile idiopathic arthritis (JIA):_________________________________

177.

Specify other connective tissue disease:_________________________________

178.

Specify other vasculitis:_________________________________

179.

Specify other autoimmune neurological disorder:_________________________________

180.

Specify other autoimmune cytopenia:_________________________________

181.

Specify other autoimmune bowel disorder:_________________________________

- Go to signature line

Other Disease

CIBMTR Form 2402 revision 21 (page 76 of 77) Draft 37/236/20176

CIBMTR Center Number: ___ ___ ___ ___ ___
182.

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Specify other disease: _________________________________________

First Name: ____________________________________________________________________________

Last Name: ________________________________________________________________________________
E-mail address: ____________________________________________________________________________

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

MM

DD

CIBMTR Form 2402 revision 21 (page 77 of 77) Draft 37/236/20176


File Typeapplication/pdf
File TitleMicrosoft Word - Draft Pre-TED 2402 - Disease Classification r2.docx
Authordoleysh
File Modified2017-04-18
File Created2017-04-18

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