CIBMTR Form 2057 revision 1 (page 1 of 34). Form released May, 2020. Last Updated May, 2020. Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved. Myeloproliferative Neoplasms (MPN) Pre-Infusion Data Registry Use Only Sequence Number: Date Received: CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Event date: __ __ __ __ / __ __ / __ __ YYYY MM DD Preview only
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Registry Use Only Preview only€¦ · ☐ MF - 1: Loose network of reticulin with many intersections, especially in perivascular areas ☐ MF - 2: Diffuse and dense increase in reticulin
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CIBMTR Form 2057 revision 1 (page 1 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
Myeloproliferative Neoplasms (MPN) Pre-Infusion Data
1. Is this the report of a second or subsequent transplant or cellular therapy for the same disease?
☐ Yes - Go to question 41
☐ No - Go to question 2
2. Specify transfusion dependence at diagnosis
☐ Non-transfused (NTD) – 0 RBCs in 16 weeks
☐ Low-transfusion burden (LTB) – (3-7 RBCs in 16 weeks in at least 2 transfusion episodes; maximum of 3 in 8 weeks)
☐ High-transfusion burden (HTB) – (≥ 8 RBCs in 16weeks; ≥ 4 in 8 weeks)
3. Did the recipient have splenomegaly at diagnosis?
☐ Yes
☐ No
☐ Unknown
☐ Not applicable (splenectomy)
7. Did the recipient have hepatomegaly at diagnosis?
☐ Yes
☐ No
☐ Unknown
4. Specify the method used to measure spleen size
☐ Physical assessment
☐ Ultrasound
☐ CT/ MRI
8. Specify the method used to measure liver size
☐ Physical assessment
☐ Ultrasound
☐ CT/ MRI
CIBMTR Form 2057 revision 1 (page 2 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
Report findings prior to any first treatment of the primary disease for which the HCT / cellular therapy is being performed.
11. DateCBCwithdifferentialdrawn:________/____/____ YYYY MM DD
12. Neutrophils
☐ Known
☐ Unknown
14. Bands
☐ Known
☐ Unknown
16. Metamyelocytes
☐ Known
☐ Unknown
18. Myelocytes
☐ Known
☐ Unknown
20. Lymphocytes
☐ Known
☐ Unknown
22. Monocytes
☐ Known
☐ Unknown
24. Basophils
☐ Known
☐ Unknown
26. Eosinophils
☐ Known
☐ Unknown
28. Was a bone marrow examination performed?
☐ Yes
☐ No
☐ Unknown
CIBMTR Form 2057 revision 1 (page 3 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
Diagnostic Studies (Measured Prior to Any Disease Treatment)
13. ___ ___%
15. ___ ___%
17. ___ ___%
19. ___ ___%
21. ___ ___%
23. ___ ___%
25. ___ ___%
27. ___ ___%
29. Date sample collected: __ __ __ __ / __ __ / __ __ YYYY MM DD
33. Were molecular tests for molecular markers performed? (e.g. PCR) (please do not include driver mutations JAK2, CALR, MPL, and CSF3R as previously captured on the Disease Classification F2402)
☐ Yes
☐ No
☐ Unknown
34. Indicate if a positive molecular marker(s) was identified
☐ Yes
☐ No
CIBMTR Form 2057 revision 1 (page 4 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
31. Myelofibrosis grading by WHO classification
☐ Known
☐ Unknown
35. Date sample collected: __ __ __ __ / __ __ / __ __ YYYY MM DD
36. Specify the positive molecular marker
☐ ASXL1
☐ BCOR
☐ BCORL1
☐ CBL
☐ CUX1
☐ DNMT3A
☐ ETV6
☐ EZH2
☐ FLT3
☐ GATA2
☐ IDH1
☐ IDH2
☐ IKZF1
☐ KRAS
☐ LNK
☐ NF1
☐ NPM1
☐ NRAS
☐ PHF6
☐ PPM1D
☐ PTPN11
☐ P53 (TP53)
☐ RUNX1
☐ SETBP1
☐ SF3B1
32. Specify the Grade
☐ MF - 0: Scattered linear reticulin with no intersection (crossovers) corresponding to normal BM
☐ MF - 1: Loose network of reticulin with many intersections, especially in perivascular areas
☐ MF - 2: Diffuse and dense increase in reticulin with extensive intersections, occasionally with focal bundles of thick fibers mostly consistent with collagen, and/or focal osteosclerosis
☐ MF - 3: Diffuse and dense increase in reticulin with extensive intersections and coarse bundles of thick fibers consistent with collagen, usually associated with osteosclerosis
CIBMTR Form 2057 revision 1 (page 5 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
40. Was documentation submitted to the CIBMTR? ☐ Yes ☐ No
☐ SRSF2
☐ STAG2
☐ TET2
☐ U2AF1
☐ WT1
☐ ZRSR2
☐ Other molecular marker
Copy questions 36 - 39 to report more than one gene mutation
37. Specify other molecular marker:___________________________
41. Specify the maximum DIPSS score the patient ever achieved: ___
42. Specify when maximum DIPSS score was documented
☐ At diagnosis - Go to question 55
☐ Between diagnosis and the preparative regimen - Go to question 43
☐ At last evaluation prior to the start of the preparative regimen - Go to question 55
Report the clinical and laboratory assessments used to determine the maximum DIPSS score
43. Date CBC drawn: __ __ __ __ / __ __ / __ __ YYYY MM DD
44. WBC
☐ Known
☐ Unknown
46. Blasts in blood
☐ Known
☐ Unknown
48. Hemoglobin
☐ Known
☐ Unknown
51. Platelets
☐ Known
☐ Unknown
54. Did the recipient have constitutional symptoms? (> 10% weight loss in 6 months, night sweats, or unexplained fever higher than 37.5°C)
☐ Yes ☐ No ☐ Unknown
CIBMTR Form 2057 revision 1 (page 6 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
DIPSS Prognosis Score
45. ___ ___ ___ ___ ___ ___ • ___ ☐ x 109/L (x 103/mm3) ☐ x 106/L
☐ NoSpecify laboratory findings immediately prior to this line of therapy 56. Date CBC with differential drawn: __ __ __ __ / __ __ / __ __ YYYY MM DD
57. WBC
☐ Known
☐ Unknown
59. Neutrophils
☐ Known
☐ Unknown
61. Bands
☐ Known
☐ Unknown
63. Metamyelocytes
☐ Known
☐ Unknown
65. Myelocytes
☐ Known
☐ Unknown
67. Lymphocytes
☐ Known
☐ Unknown
69. Monocytes
☐ Known
☐ Unknown
71. Basophils
☐ Known
☐ Unknown
73. Eosinophils
☐ Known
☐ Unknown
CIBMTR Form 2057 revision 1 (page 7 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
86. Did the recipient have constitutional symptoms? (> 10% weight loss in 6 months, night sweats, or unexplained fever higher than 37.5°C)
☐ Yes ☐ No ☐ Unknown
87. Were tests for driver mutations performed?
☐ Yes ☐ No ☐ Unknown
CIBMTR Form 2057 revision 1 (page 8 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
76. ___ ___ ___ %
84. ___ ___ ___ %
85. Date sample collected: __ __ __ __ / __ __ / __ __ YYYY MM DD
98. Were molecular tests for molecular markers performed? (e.g. PCR) (please do not include driver mutations JAK2, CALR, MPL, and CSF3R as previously captured above)
☐ Yes ☐ No ☐ Unknown
99. Indicate if a positive molecular marker(s) was identified
☐ Yes ☐ No
CIBMTR Form 2057 revision 1 (page 9 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
91. CALR
☐ Positive
☐ Negative
☐ Not done
95. MPL ☐ Positive ☐ Negative ☐ Not done
96. CSF3R ☐ Positive ☐ Negative ☐ Not done
97. Was documentation submitted to the CIBMTR? ☐ Yes ☐ No
100. Specify the total number of positive molecular markers: ___ ___
101. Date sample collected: __ __ __ __ / __ __ / __ __ YYYY MM DD
CIBMTR Form 2057 revision 1 (page 10 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Form 2057 revision 1 (page 11 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Form 2057 revision 1 (page 12 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Form 2057 revision 1 (page 13 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Form 2057 revision 1 (page 14 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Form 2057 revision 1 (page 15 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Form 2057 revision 1 (page 16 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Form 2057 revision 1 (page 17 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Form 2057 revision 1 (page 18 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Form 2057 revision 1 (page 19 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Form 2057 revision 1 (page 20 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Form 2057 revision 1 (page 21 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Form 2057 revision 1 (page 22 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Form 2057 revision 1 (page 23 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Form 2057 revision 1 (page 24 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Form 2057 revision 1 (page 25 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
163. Were cytogenetics tested? (karyotyping or FISH)
☐ Yes
☐ No
☐ Unknown
162. Was documentation submitted to the CIBMTR? ☐ Yes ☐ No
164. Were cytogenetics tested via FISH?
☐ Yes
☐ No 165. Sample source ☐ Blood ☐ Bone Marrow
166. Date sample collected: __ __ __ __ / __ __ / __ __ YYYY MM DD
167. Results of tests
☐Abnormalitiesidentified
☐ No abnormalities
Specify cytogenetic abnormalities identified via FISH prior to this line of therapy
168. International System for Human Cytogenetic Nomenclature (ISCN) compatible string:
________________________________
169. Specify number of distinct cytogenetic abnormalities
CIBMTR Form 2057 revision 1 (page 26 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
173. Were cytogenetics tested via karyotyping?
☐ Yes
☐ No
172. Was documentation submitted to the CIBMTR? (e.g. FISH report)
☐ Yes ☐ No
Deletion
☐ del(5q) / 5q-
☐ del(7q) / 7q-
☐ del(11q) / 11q-
☐ del(12p) / 12p-
☐ del(13q) / 13q-
☐ del(20q) / 20q-
Inversion
☐ dup(1)
☐ inv(3)
Other
☐ i17q
☐ Other abnormality
171. Specify other abnormality:
_______________________
174. Sample source ☐ Blood ☐ Bone Marrow
175. Date sample collected: __ __ __ __ / __ __ / __ __ YYYY MM DD
176. Results of tests
☐Abnormalitiesidentified
☐ No evaluable metaphases
☐ No abnormalities
Specify cytogenetic abnormalities identified via conventional cytogenetics prior to this line of therapy
177. International System for Human Cytogenetic Nomenclature (ISCN) compatible string:
CIBMTR Form 2057 revision 1 (page 27 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
178. Specify number of distinct cytogenetic abnormalities
CIBMTR Form 2057 revision 1 (page 28 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
Line of Therapy
182. Systemic therapy
☐ Yes
☐ No
181. Was documentation submitted to the CIBMTR? (e.g. karyotyping report)
☐ Yes ☐ No
183. Date therapy started
☐ Known
☐ Unknown
185. Date therapy stopped
☐ Known
☐ Unknown
187. Specify the reason therapy stopped
☐ Toxicity (e.g. cytopenia)
☐ Not tolerable
☐ Lack of response
☐ Disease progression
☐ Response (treatment achieved goal)
☐ Other
☐ Unknown
189. Specify systemic drugs given (check all drugs given as part of this line of therapy)
194. Cellular therapy (e.g. CAR-T cells) ☐ Yes ☐ No
195. Blinded randomized trial
☐ Yes
☐ No
197. Splenic radiation ☐ Yes ☐ No
198. Splenectomy
☐ Yes
☐ No
200. Other therapy
☐ Yes
☐ No
202. Best response to line of therapy
☐ Complete clinical remission (CR) - Go to question 206
☐ Partial clinical remission (PR) - Go to question 206
☐ Clinical Improvement (CI) - Go to question 203
☐ Stable disease (SD) - Go to question 206
☐ Progressive disease - Go to question 206
☐ Relapse - Go to question 206
☐ Progression to AML (AML) - Go to question 206
☐ Not assessed - Go to question 207
CIBMTR Form 2057 revision 1 (page 29 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
190. Specify other JAK1 or JAK2 inhibitor:_______________________
191. Specify other systemic therapy: ___________________________
193. Specify supportive treatment given (check all that apply)
207. Specify the best cytogenetic response to line of therapy
☐ Complete response (CR): Eradication of pre-existing abnormality - Go to question 208
☐ Partial response (PR): ≥ 50% reduction in abnormal metaphases - Go to question 208
☐ Re-emergence of pre-existing cytogenetic abnormality - Go to question 208
☐ Not assessed - Go to question 209
☐ Not applicable - Go to question 209
☐ None of the above (Does not meet the CR or PR criteria) - Go to question 208
209. Specify the best molecular response to line of therapy
☐ Complete response (CR): Eradication of pre-existing abnormality - Go to question 210
☐ Partial response (PR): ≥50% decrease in allele burden - Go to question 210
☐ Re-emergence of pre-existing molecular abnormality - Go to question 210
☐ Not assessed - Go to question 211
☐ Not applicable - Go to question 211
☐ None of the above (Does not meet the CR or PR criteria) - Go to question 210
211. Did disease relapse/progress following this line of therapy?
☐ Yes
☐ No
Copy questions 56 - 212 if needed for multiple lines of therapy
CIBMTR Form 2057 revision 1 (page 30 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
208. Date assessed: __ __ __ __ / __ __ / __ __ YYYY MM DD
210. Date assessed: __ __ __ __ / __ __ / __ __ YYYY MM DD
212. Date of relapse/progression: __ __ __ __ / __ __ / __ __ YYYY MM DD
213.DateCBCwithdifferentialdrawn:________/____/____ YYYY MM DD
214. Neutrophils
☐ Known
☐ Unknown
216. Bands
☐ Known
☐ Unknown
218. Metamyelocytes
☐ Known
☐ Unknown
220. Myelocytes
☐ Known
☐ Unknown
222. Monocytes
☐ Known
☐ Unknown
224. Basophils
☐ Known
☐ Unknown
226. Eosinophils
☐ Known
☐ Unknown
228. Was a bone marrow examination performed?
☐ Yes
☐ No
☐ Unknown
CIBMTR Form 2057 revision 1 (page 31 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion
215. ___ ___%
217. ___ ___%
219. ___ ___%
221. ___ ___%
223. ___ ___%
225. ___ ___%
227. ___ ___%
229. Date sample collected: __ __ __ __ / __ __ / __ __ YYYY MM DD
233. Were molecular tests for molecular markers performed? (e.g. PCR) (please do not include driver mutations JAK2, CALR, MPL, and CSF3R as previously captured on the Disease Classification F2402)
☐ Yes
☐ No
☐ Unknown
CIBMTR Form 2057 revision 1 (page 32 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
231. Myelofibrosis grading by WHO classification
☐ Known
☐ Unknown232. Specify the Grade
☐ MF - 0: Scattered linear reticulin with no intersection (crossovers) corresponding to normal BM
☐ MF - 1: Loose network of reticulin with many intersections, especially in perivascular areas
☐ MF - 2: Diffuse and dense increase in reticulin with extensive intersections, occasionally with focal bundles of thick fibers mostly consistent with collagen, and/or focal osteosclerosis
☐ MF - 3: Diffuse and dense increase in reticulin with extensive intersections and coarse bundles of thick fibers consistent with collagen, usually associated with osteosclerosis
234. Indicate if a positive molecular marker(s) was identified
☐ Yes
☐ No235. Date sample collected: __ __ __ __ / __ __ / __ __ YYYY MM DD
CIBMTR Form 2057 revision 1 (page 33 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Form 2057 revision 1 (page 34 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion
258. Indicate how the iron overload diagnosis was made