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pdfPost-Transplant Essential Data
OMB No: 0915-0310
Expiration Date: 10/31/2022
Registry Use Only
Sequence Number:
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 when collected at 100 days post-transplant, 0.85 hours
per response when collected at 6 months post-transplant, 0.65 hours per response
when collected at 1 and 2 years post-transplant, and 0.52 hours per response annually thereafter, 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 14N39, Rockville, Maryland, 20857.
Date Received:
CIBMTR Center Number: ___ ___ ___ ___ ___
CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
Event date: __ __ __ __ / __ __ / __ __
YYYY
MM
DD
Visit
☐ 100 day
☐ 6 months
☐ 1 year
☐ 2 years
☐ >2 years Specify: ___ ___
CIBMTR Form 2450 revision 5 (page 1 of 16). Form released January, 2020. Last Updated January, 2021.
Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Center Number: ___ ___ ___ ___ ___
CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
Survival
1.
Date of actual contact with the recipient to determine medical status for this follow-up report: __ __ __ __ / __ __ / __ __
YYYY
MM
DD
2.
Specify the recipient’s survival status at the date of last contact
☐ Alive – Answers to subsequent questions should reflect clinical status since the date of last report. - Go to question 7
☐ Dead – Answers to subsequent questions should reflect clinical status between the date of last report and immediately prior to
death. - Go to question 3
3.
Primary cause of death
☐ Recurrence / persistence / progression of disease for which the HCT or cellular therapy was performed
- Go to question 5
☐ Acute GVHD - Go to question 5
☐ Chronic GVHD - Go to question 5
☐ Graft rejection or failure - Go to question 5
☐ Cytokine release syndrome - Go to question 5
Infection
☐ Infection, organism not identified - Go to question 5
☐ Bacterial infection - Go to question 5
☐ Fungal infection - Go to question 5
☐ Viral infection - Go to question 5
☐ COVID-19 (SARS-CoV-2) - Go to question 5
☐ Protozoal infection - Go to question 5
☐ Other infection - Go to question 4
Pulmonary
☐ Idiopathic pneumonia syndrome (IPS) - Go to question 5
☐ Pneumonitis due to Cytomegalovirus (CMV) - Go to question 5
☐ Pneumonitis due to other virus - Go to question 5
☐ Other pulmonary syndrome (excluding pulmonary hemorrhage) - Go to question 4
☐ Diffuse alveolar damage (without hemorrhage) - Go to question 5
☐ Acute respiratory distress syndrome (ARDS) (other than IPS) - Go to question 5
Organ failure (not due to GVHD or infection)
☐ Liver failure (not VOD) - Go to question 5
☐ Veno-occlusive disease (VOD) / sinusoidal obstruction syndrome (SOS) - Go to question 5
☐ Cardiac failure - Go to question 5
☐ Pulmonary failure - Go to question 5
☐ Central nervous system (CNS) failure - Go to question 5
☐ Renal failure - Go to question 5
☐ Gastrointestinal (GI) failure (not liver) - Go to question 5
☐ Multiple organ failure - Go to question 4
☐ Other organ failure - Go to question 4
Malignancy
☐ New malignancy (post-HCT or post-cellular therapy) - Go to question 5
☐ Prior malignancy (malignancy initially diagnosed prior to HCT or cellular therapy, other than the malignancy for
which the HCT or cellular therapy was performed) - Go to question 5
CIBMTR Form 2450 revision 5 (page 2 of 16). OMB No: 0915-0310. Expiration Date: 10/31/2022. Form released January, 2020.
Last Updated January, 2021. Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Center Number: ___ ___ ___ ___ ___
CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
Hemorrhage
☐ Pulmonary hemorrhage - Go to question 5
☐ Diffuse alveolar hemorrhage (DAH) - Go to question 5
☐ Intracranial hemorrhage - Go to question 5
☐ Gastrointestinal hemorrhage - Go to question 5
☐ Hemorrhagic cystitis - Go to question 5
☐ Other hemorrhage - Go to question 4
Vascular
☐ Thromboembolic - Go to question 5
☐ Disseminated intravascular coagulation (DIC) - Go to question 5
☐ Thrombotic microangiopathy (TMA) (Thrombotic thrombocytopenic purpura (TTP)/Hemolytic Uremic Syndrome
(HUS)) - Go to question 5
☐ Other vascular - Go to question 4
Other
☐ Accidental death - Go to question 5
☐ Suicide - Go to question 5
☐ Other cause - Go to question 4
4.
5.
Specify:_________________________________________________________________
Contributing cause of death (check all that apply)
☐ Recurrence / persistence / progression of disease for which the HCT or cellular therapy was performed
- Go to question 7
☐ Acute GVHD - Go to question 7
☐ Chronic GVHD - Go to question 7
☐ Graft rejection or failure - Go to question 7
☐ Cytokine release syndrome - Go to question 7
Infection
☐ Infection, organism not identified - Go to question 7
☐ Bacterial infection - Go to question 7
☐ Fungal infection - Go to question 7
☐ Viral infection - Go to question 7
☐ COVID-19 (SARS-CoV-2) - Go to question 7
☐ Protozoal infection - Go to question 7
☐ Other infection - Go to question 6
Pulmonary
☐ Idiopathic pneumonia syndrome (IPS) - Go to question 7
☐ Pneumonitis due to Cytomegalovirus (CMV) - Go to question 7
☐ Pneumonitis due to other virus - Go to question 7
☐ Other pulmonary syndrome (excluding pulmonary hemorrhage) - Go to question 6
☐ Diffuse alveolar damage (without hemorrhage) - Go to question 7
☐ Acute respiratory distress syndrome (ARDS) (other than IPS) - Go to question 7
Organ failure (not due to GVHD or infection)
☐ Liver failure (not VOD) - Go to question 7
CIBMTR Form 2450 revision 5 (page 3 of 16). OMB No: 0915-0310. Expiration Date: 10/31/2022. Form released January, 2020.
Last Updated January, 2021. Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Center Number: ___ ___ ___ ___ ___
CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
☐ Veno-occlusive disease (VOD) / sinusoidal obstruction syndrome (SOS) - Go to question 7
☐ Cardiac failure - Go to question 7
☐ Pulmonary failure - Go to question 7
☐ Central nervous system (CNS) failure - Go to question 7
☐ Renal failure - Go to question 7
☐ Gastrointestinal (GI) failure (not liver) - Go to question 7
☐ Multiple organ failure - Go to question 6
☐ Other organ failure - Go to question 6
Malignancy
☐ New malignancy (post-HCT or post-cellular therapy) - Go to question 7
☐ Prior malignancy (malignancy initially diagnosed prior to HCT or cellular therapy, other than the malignancy for
which the HCT or cellular therapy was performed) - Go to question 7
Hemorrhage
☐ Pulmonary hemorrhage - Go to question 7
☐ Diffuse alveolar hemorrhage (DAH) - Go to question 7
☐ Intracranial hemorrhage - Go to question 7
☐ Gastrointestinal hemorrhage - Go to question 7
☐ Hemorrhagic cystitis - Go to question 7
☐ Other hemorrhage - Go to question 6
Vascular
☐ Thromboembolic - Go to question 7
☐ Disseminated intravascular coagulation (DIC) - Go to question 7
☐ Thrombotic microangiopathy (TMA) (Thrombotic thrombocytopenic purpura (TTP)/Hemolytic Uremic Syndrome
(HUS)) - Go to question 7
☐ Other vascular - Go to question 6
Other
☐ Accidental death - Go to question 7
☐ Suicide - Go to question 7
☐ Other cause - Go to question 6
6.
Specify:__________________________________________________________________
CIBMTR Form 2450 revision 5 (page 4 of 16). OMB No: 0915-0310. Expiration Date: 10/31/2022. Form released January, 2020.
Last Updated January, 2021. Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Center Number: ___ ___ ___ ___ ___
CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
Subsequent Transplant
7.
Did the recipient receive a subsequent HCT since the date of last report?
☐ Yes
☐ No
8.
Date of subsequent HCT: __ __ __ __ / __ __ / __ __
YYYY
MM
DD
9.
What was the indication for subsequent HCT?
☐ Graft failure / insufficient hematopoietic recovery – Allogeneic HCTs Complete a Pre-TED Form 2400
for the subsequent HCT - Go to question 11
☐ Persistent primary disease – Complete a Pre-TED Form 2400 for the subsequent HCT
- Go to question 11
☐ Recurrent primary disease – Complete a Pre-TED Form 2400 for the subsequent HCT
- Go to question 11
☐ Planned subsequent HCT, per protocol – Complete a Pre-TED Form 2400 for the subsequent HCT
- Go to question 11
☐ New malignancy (including PTLD and EBV lymphoma) – Complete a Pre-TED Form 2400 for the
subsequent HCT - Go to question 11
☐ Insufficient chimerism – Complete a Pre-TED Form 2400 for the subsequent HCT
- Go to question 11
☐ Other – Complete a Pre-TED Form 2400 for the subsequent HCT - Go to question 10
10. Specify other indication: ________________________________________________
11. Source of HSCs (check all that apply)
☐ Allogeneic, related
☐ Allogeneic, unrelated
☐ Autologous
12. Has the recipient received a cellular therapy since the date of last report? (e.g. CAR-T, DCI)
☐ Yes – Also complete Cellular Therapy Essential Data Pre-Infusion Form 4000
☐ No
13. Date of cellular therapy: __ __ __ __ / __ __ / __ __
YYYY
MM
DD
Initial ANC Recovery
14. Was there evidence of initial hematopoietic recovery?
☐ Yes (ANC ≥ 500/mm achieved and sustained for 3 lab values) - Go to question 15
☐ No (ANC ≥ 500/mm was not achieved) - Go to question 16
☐ Not applicable (ANC never dropped below 500/mm at any time after the start of the preparative regimen) - Go to question 16
☐ Previously reported (Recipient’s initial hematopoietic recovery was recorded on a previous report) - Go to question 16
3
3
3
15. Date ANC ≥ 500/mm3 (first of 3 lab values): __ __ __ __ / __ __ / __ __
YYYY
MM
DD
16. Did late graft failure occur?
☐ Yes
☐ No
CIBMTR Form 2450 revision 5 (page 5 of 16). OMB No: 0915-0310. Expiration Date: 10/31/2022. Form released January, 2020.
Last Updated January, 2021. Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Center Number: ___ ___ ___ ___ ___
CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
Initial Platelet Recovery
(Optional for Non-U.S. Centers)
17. Was an initial platelet count ≥ 20 x 109/L achieved?
☐ Yes - Go to question 18
☐ No - Go to question 19
☐ Not applicable - Platelet count never dropped below 20 x 10 /L - Go to question 19
☐ Previously reported - ≥ 20 x 10 /L was achieved and reported previously - Go to question 19
9
9
18. Date platelets ≥ 20 x 109/L: __ __ __ __ / __ __ / __ __
YYYY
MM
DD
Graft vs. Host Disease
If an allogeneic donor was used for the recipient’s HCT or cellular therapy, report all graft-versus-host disease occurring in this reporting
period. If an allogeneic donor was not used, continue to Liver Toxicity Prophylaxis, question 45.
19. Did acute GVHD develop since the date of last report?
☐ Yes
☐ No
☐ Unknown
20. Date of acute GVHD diagnosis: __ __ __ __ / __ __ / __ __ - Go to question 22
YYYY
MM
DD
21. Did acute GVHD persist since the date of last report?
☐ Yes - Go to question 29
☐ No - Go to question 37
☐ Unknown - Go to question 37
22. Overall grade of acute GVHD at diagnosis:
☐ I - Rash on ≤ 50% of skin, no liver or gut involvement
☐ II - Rash on > 50% of skin, bilirubin 2-3 mg/dL, or diarrhea 500-1000 mL/day or persistent nausea or vomiting
☐ III - Bilirubin 3-15 mg/dL, or gut stage 2-4 diarrhea > 1000 mL/day or severe abdominal pain with or without ileus
☐ IV - Generalized erythroderma with bullous formation, or bilirubin >15 mg/dL
☐ Not applicable (acute GVHD present but cannot be graded)
List the stage for each organ at diagnosis of acute GVHD:
23. Skin
☐ Stage 0 – no rash, no rash attributable to acute GVHD
☐ Stage 1 – maculopapular rash, < 25% of body surface
☐ Stage 2 – maculopapular rash, 25-50% of body surface
☐ Stage 3 – generalized erythroderma, > 50% of body surface
☐ Stage 4 – generalized erythroderma with bullae formation and/or desquamation
24. Lower intestinal tract (use mL/day for adult recipients and mL/kg/day for pediatric recipients)
☐ Stage 0 – no diarrhea, no diarrhea attributable to acute GVHD / diarrhea < 500 mL/day (adult), or < 10 mL/kg/day
(pediatric)
☐ Stage 1 – diarrhea 500-1000 mL/day (adult), or 10-19.9 mL/kg/day (pediatric)
☐ Stage 2 – diarrhea 1001-1500 mL/day (adult), or 20-30 mL/kg/day (pediatric)
☐ Stage 3 – diarrhea > 1500 mL/day (adult), or > 30 mL/kg/day (pediatric)
☐ Stage 4 – severe abdominal pain, with or without ileus, and/or grossly bloody stool
CIBMTR Form 2450 revision 5 (page 6 of 16). OMB No: 0915-0310. Expiration Date: 10/31/2022. January, 2020.
Last Updated January, 2021. Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Center Number: ___ ___ ___ ___ ___
CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
25. Upper intestinal tract
☐ Stage 0 – no persistent nausea or vomiting
☐ Stage 1 – persistent nausea or vomiting
26. Liver
☐ Stage 0 – no liver acute GVHD / bilirubin < 2.0 mg/dL (< 34 μmol/L)
☐ Stage 1 – bilirubin 2.0-3.0 mg/dL (34-52 μmol/L)
☐ Stage 2 – bilirubin 3.1-6.0 mg/dL (53-103 μmol/L)
☐ Stage 3 – bilirubin 6.1-15.0 mg/dL (104-256 μmol/L)
☐ Stage 4 – bilirubin > 15.0 mg/dL (> 256 μmol/L)
27. Other site(s) involved with acute GVHD
☐ Yes
☐ No
28. Specify other site(s):____________________________________________
Specify the maximum overall grade and organ staging of acute GVHD since the date of last report:
29. Maximum overall grade of acute GVHD
☐ I - Rash on ≤ 50% of skin, no liver or gut involvement
☐ II - Rash on > 50% of skin, bilirubin 2-3 mg/dL, or diarrhea 500-1000 mL/day or persistent nausea or vomiting
☐ III - Bilirubin 3-15 mg/dL, or gut stage 2-4 diarrhea > 1000 mL/day or severe abdominal pain with or without ileus
☐ IV - Generalized erythroderma with bullous formation, or bilirubin >15 mg/dL
☐ Not applicable (acute GVHD present but cannot be graded)
30. Date maximum overall grade of acute GVHD:
__ __ __ __ / __ __ / __ __
YYYY
MM
DD
31. Skin
☐ Stage 0 – no rash, no rash attributable to acute GVHD
☐ Stage 1 – maculopapular rash, < 25% of body surface
☐ Stage 2 – maculopapular rash, 25–50% of body surface
☐ Stage 3 – generalized erythroderma, > 50% of body surface
☐ Stage 4 – generalized erythroderma with bullae formation and/or desquamation
32. Lower intestinal tract (use mL/day for adult recipients and mL/kg/day for pediatric recipients)
☐ Stage 0 – no diarrhea, no diarrhea attributable to acute GVHD / diarrhea < 500 mL/day (adult), or < 10 mL/kg/day
(pediatric)
☐ Stage 1 – diarrhea 500 - 1000 mL/day (adult), or 10 - 19.9 mL/kg/day (pediatric)
☐ Stage 2 – diarrhea 1001 - 1500 mL/day (adult), or 20 - 30 mL/kg/day (pediatric)
☐ Stage 3 – diarrhea > 1500 mL/day (adult), or > 30 mL/kg/day (pediatric)
☐ Stage 4 – severe abdominal pain, with or without ileus, and/or grossly bloody stool
33. Upper intestinal tract
☐ Stage 0 – no persistent nausea or vomiting
☐ Stage 1 – persistent nausea or vomiting
CIBMTR Form 2450 revision 5 (page 7 of 16). OMB No: 0915-0310. Expiration Date: 10/31/2022. January, 2020.
Last Updated January, 2021. Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Center Number: ___ ___ ___ ___ ___
CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
34. Liver
☐ Stage 0 – No liver acute GVHD / bilirubin < 2.0 mg/dL (< 34 μmol/L)
☐ Stage 1 – bilirubin 2.0–3.0 mg/dL (34–52 μmol/L)
☐ Stage 2 – bilirubin 3.1–6.0 mg/dL (53–103 μmol/L)
☐ Stage 3 – bilirubin 6.1–15.0 mg/dL (104–256 μmol/L)
☐ Stage 4 – bilirubin > 15.0 mg/dL (> 256 μmol/L)
35. Other site(s) involved with acute GVHD
☐ Yes
☐ No
36. Specify other site(s):______________________________________
37. Did chronic GVHD develop since the date of last report?
☐ Yes
☐ No
☐ Unknown
38. Date of chronic GVHD diagnosis: __ __ __ __ / __ __ / __ __ ☐ Date estimated
YYYY
MM
DD - Go to question 40
39. Did chronic GVHD persist since the date of last report?
☐ Yes
☐ No
☐ Unknown
Specify the maximum grade of chronic GVHD since the date of last report:
40. Maximum grade of chronic GVHD (according to best clinical judgment)
☐ Mild
☐ Moderate
☐ Severe
☐ Unknown
41. Specify if chronic GVHD was limited or extensive
☐ Limited – localized skin involvement and/or liver dysfunction
☐ Extensive – one or more of the following:
– generalized skin involvement; or,
– liver histology showing chronic aggressive hepatitis, bridging necrosis or cirrhosis; or,
– involvement of eye: Schirmer’s test with < 5 mm wetting; or
– involvement of minor salivary glands or oral mucosa demonstrated on labial biopsy; or
– involvement of any other target organ
42. Date of maximum grade of chronic GVHD:
__ __ __ __ / __ __ / __ __
YYYY
MM
DD
43. Is the recipient still taking systemic steroids? (Do not report steroids for adrenal insufficiency, or steroid dose ≤10 mg/day for adults, <0.1 mg/
kg/day for children)
☐ Yes
☐ No
☐ Not applicable
☐ Unknown
44. Is the recipient still taking (non-steroid) immunosuppressive agents (including PUVA) for GVHD?
☐ Yes
☐ No
☐ Not applicable
☐ Unknown
CIBMTR Form 2450 revision 5 (page 8 of 16). OMB No: 0915-0310. Expiration Date: 10/31/2022. January, 2020.
Last Updated January, 2021. Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Center Number: ___ ___ ___ ___ ___
CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
Liver Toxicity Prophylaxis
45. Was specific therapy used to prevent liver toxicity?
☐ Yes
☐ No
46. Specify therapy (check all that apply)
☐ Defibrotide
☐ N-acetylcysteine
☐ Tissue plasminogen activator (TPA)
☐ Ursodiol
☐ Other therapy
47. Specify other therapy:____________________
Veno-occlusive disease (VOD) / Sinusoidal obstruction syndrome (SOS)
Specify if the recipient developed VOD / SOS since the date of last report:
48. Did veno-occlusive disease (VOD) / sinusoidal obstruction syndrome (SOS) develop since the date of last report?
☐ Yes
☐ No
49. Date of diagnosis: __ __ __ __ / __ __ / __ __
YYYY
MM
DD
Infection
50. Did the recipient develop COVID-19 (SARS-CoV-2) since the date of last report?
☐ Yes
☐ No
51. Date of diagnosis: __ __ __ __ / __ __ / __ __
YYYY
MM
DD
Copy and complete questions 50 - 51 to report more than one infection.
New Malignancy, Lymphoproliferative or Myeloproliferative Disease / Disorder
Report new malignancies that are different than the disease / disorder for which HCT was performed. Do not include relapse, progression
or transformation of the same disease subtype.
52. Did a new malignancy, myelodysplastic, myeloproliferative, or lymphoproliferative disease / disorder occur that is different from the disease /
disorder for which the HCT or cellular therapy was performed? (include clonal cytogenetic abnormalities, and post-transplant
lymphoproliferative disorders)
☐ Yes
☐ No
Copy and complete questions 53-59 to report each new malignancy diagnosed since the date of last report.
The submission of a pathology report or other supportive documentation for each reported new malignancy is
strongly recommended.
53. Specify the new malignancy
☐ Acute myeloid leukemia (AML / ANLL) - Go to question 56
☐ Other leukemia - Go to question 56
☐ Myelodysplastic syndrome (MDS) - Go to question 56
☐ Myeloproliferative neoplasm (MPN) - Go to question 56
☐ Myelodysplasia / myeloproliferative neoplasm (MDS / MPN) - Go to question 56
☐ Hodgkin lymphoma - Go to question 55
☐ Non-Hodgkin lymphoma - Go to question 55
☐ Post-transplant lymphoproliferative disorder (PTLD) - Go to question 55
☐ Clonal cytogenetic abnormality without leukemia or MDS - Go to question 56
☐ Uncontrolled proliferation of donor cells without malignant transformation - Go to question 56
CIBMTR Form 2450 revision 5 (page 9 of 16). Form released January, 2020. Last Updated January, 2020.
Last Updated January, 2021. National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Center Number: ___ ___ ___ ___ ___
CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
☐ Breast cancer - Go to question 56
☐ Central nervous system (CNS) malignancy (e.g. glioblastoma, astrocytoma) - Go to question 56
☐ Gastrointestinal malignancy (e.g. colon, rectum, stomach, pancreas, intestine) - Go to question 56
☐ Genitourinary malignancy (e.g. kidney, bladder, ovary, testicle, genitalia, uterus, cervix) - Go to question 56
☐ Lung cancer - Go to question 56
☐ Melanoma - Go to question 56
☐ Basal cell skin malignancy - Go to question 56
☐ Squamous cell skin malignancy - Go to question 56
☐ Oropharyngeal cancer (e.g. tongue, buccal mucosa) - Go to question 56
☐ Sarcoma - Go to question 56
☐ Thyroid cancer - Go to question 56
☐ Other new malignancy - Go to question 54
54. Specify other new malignancy:________________________________________________
- Go to question 56
55. Is the tumor EBV positive?
☐ Yes ☐ No
56. Date of diagnosis: __ __ __ __ / __ __ / __ __
YYYY
MM
DD
57. Was documentation submitted to the CIBMTR? (e.g. pathology / autopsy report or other documentation)
☐ Yes
☐ No
58. Was the new malignancy donor / cell product derived?
☐ Yes
☐ No
☐ Not done
59. Was documentation submitted to the CIBMTR? (e.g. cell origin evaluation (VNTR,
cytogenetics, FISH))
☐ Yes
☐ No
Chimerism Studies (Cord Blood Units, Beta Thalassemia, and Sickle Cell Disease Only)
This section relates to chimerism studies from allogeneic HCTs using cord blood units or for recipients whose primary disease is beta
thalassemia or sickle cell disease. If this was an autologous HCT, or an allogeneic HCT using a bone marrow or PBSC product, or a
different primary disease, continue to disease assessment.
60. Were chimerism studies performed since the date of last report?
☐ Yes
☐ No - Go to question 80
61. Was documentation submitted to the CIBMTR? (e.g. chimerism laboratory reports)
☐ Yes
☐ No
62. Were chimerism studies assessed for more than one donor / multiple donors?
☐ Yes
☐ No
Provide date(s), method(s) and other information for all chimerism studies performed since the date of last report.
63.
64. NMDP cord blood unit ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
65. Registry donor ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
66. Non-NMDP cord blood unit ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
CIBMTR Form 2450 revision 5 (page 10 of 16). OMB No: 0915-0310. Expiration Date: 10/31/2022. Form released January, 2020.
Last Updated January, 2021. Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Center Number: ___ ___ ___ ___ ___
CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
67. Global Registration Identifiers for Donors (GRID): __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __
68. Date of birth: (donor / infant) __ __ __ __ / __ __ / __ __ – OR – Age: (donor/infant) ___ ___ ☐ Months
YYYY
MM
DD
69. Sex (Donor / infant) ☐ Male
☐ Years
☐ Female
70. Date sample collected: __ __ __ __ / __ __ / __ __
YYYY
MM
DD
71. Method
☐ Karyotyping for XX/XY
☐ Fluorescent in situ hybridization (FISH) for XX/XY
☐ Restriction fragment-length polymorphisms (RFLP)
☐ VNTR or STR, micro or mini satellite (Also include AFLP)
☐ Other
72. Specify:_____________________________________________________________________
73. Cell source
☐ Bone marrow
☐ Peripheral blood
74. Cell type
☐ Unsorted / whole - Go to question 76
☐ Red blood cells - Go to question 78
☐ Hematopoietic progenitor cells (CD34+ cells) - Go to question 78
☐ Total mononuclear cells (lymphs & monos) - Go to question 78
☐ T-cells (includes CD3+, CD4+, and/or CD8+) - Go to question 78
☐ B-cells (includes CD19+ or CD20+) - Go to question 78
☐ Granulocytes (includes CD33+ myeloid cells) - Go to question 78
☐ NK cells (CD56+) - Go to question 78
☐ Other
75. Specify:_____________________________________________________________________
76. Total cells examined: ___ ___ ___ ___ ___ ___
77. Number of donor cells: ___ ___ ___ ___ - Go to question 78
78. Were donor cells detected?
☐ Yes
☐ No
79. Percent donor cells: ___ ___ ___ %
Copy and complete questions 63 - 79 for multiple chimerism studies.
Disease Assessment at the Time of Best Response to HCT
80. Compared to the disease status prior to the preparative regimen, what was the best response to HCT since the date of the last report?
(Include response to any therapy given for post-HCT maintenance or consolidation, but exclude any therapy given for relapsed, persistent, or
progressive disease)
☐ Continued complete remission (CCR) – For patients transplanted in CR - Go to question 103
☐ Complete remission (CR) - Go to question 82
☐ Not in complete remission - Go to question 81
☐ Not evaluated - Go to question 103
CIBMTR Form 2450 revision 5 (page 11 of 16). OMB No: 0915-0310. Expiration Date: 10/31/2022. Form released January, 2020.
Last Updated January, 2021. Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Center Number: ___ ___ ___ ___ ___
CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
81. Specify disease status if not in complete remission
☐ Disease detected - Go to question 84
☐ No disease detected but incomplete evaluation to establish CR - Go to question 84
82. Was the date of best response previously reported?
☐ Yes - Go to question 101
☐ No
83. Date assessed: __ __ __ __ / __ __ / __ __
YYYY
MM
DD
Specify the method(s) used to assess the disease status at the time of best response:
84. Was the disease status assessed by molecular testing (e.g. PCR)?
☐ Yes
☐ No
☐ Not applicable
85. Date assessed:
__ __ __ __ / __ __ / __ __
YYYY
MM
DD
86. Was disease detected? ☐ Yes
☐ No
87. Was the disease status assessed via flow cytometry?
☐ Yes
☐ No
☐ Not applicable
88. Date assessed:
__ __ __ __ / __ __ / __ __
YYYY
MM
DD
89. Was disease detected? ☐ Yes
☐ No
90. Was the disease status assessed by cytogenetic testing (karyotyping or FISH)?
☐ Yes
☐ No
☐ Not applicable
91.
Was the disease status assessed via FISH?
☐ Yes
☐ No
☐ Not applicable
92.
Date assessed:
__ __ __ __ / __ __ / __ __
YYYY
MM
DD
93.
Was disease detected?
☐ Yes
☐ No
94. Was the disease status assessed via
karyotyping?
☐ Yes
☐ No
☐ Not applicable
95.
Date assessed:
__ __ __ __ / __ __ / __ __
YYYY
MM
DD
96.
Was disease detected?
☐ Yes
☐ No
CIBMTR Form 2450 revision 5 (page 12 of 16). OMB No: 0915-0310. Expiration Date: 10/31/2022. Form released January, 2020.
Last Updated January, 2021. Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Center Number: ___ ___ ___ ___ ___
CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
97. Was the disease status assessed by radiological assessment? (e.g. PET, MRI, CT)
☐ Yes
☐ No
☐ Not applicable
98. Date assessed:
__ __ __ __ / __ __ / __ __
YYYY
MM
DD
99. Was disease detected? ☐ Yes
☐ No
100. Was the disease status assessed by clinical / hematologic assessment?
☐ Yes
☐ No
101. Date assessed:
__ __ __ __ / __ __ / __ __
YYYY
MM
DD
102. Was disease detected? ☐ Yes
☐ No
Post-HCT Therapy
Report therapy given since the date of last report to prevent relapse or progressive disease. This may include maintenance and
consolidation therapy. Do not report any therapy given for relapsed, persistent, or progressive disease.
103. Was therapy given since the date of the last report for reasons other than relapse, persistent, or progressive disease? (Include any
maintenance and consolidation therapy.)
☐ Yes
☐ No
104. Systemic therapy (check all that apply)
☐ Blinded randomized trial - Go to question 108
☐ Cellular therapy - Go to question 108
☐ Radiation - Go to question 108
☐ Systemic therapy - Go to question 105
☐ Other therapy - Go to question 107
105. Specify systemic therapy (check all that apply)
☐ Alemtuzumab (Campath)
☐ Azacytidine (Vidaza)
☐ Blinatumomab
☐ Bortezomib (Velcade)
☐ Bosutinib
☐ Carfilzomib
☐ Chemotherapy
☐ Dasatinib (Sprycel)
☐ Decitabine (Dacogen)
☐ Gemtuzumab (Mylotarg, anti-CD33)
☐ Gilteritinib
☐ Ibrutinib
☐ Imatinib mesylate (Gleevec)
☐ Ixazomib
☐ Lenalidomide (Revlimid)
☐ Lestaurtinib
CIBMTR Form 2450 revision 5 (page 13 of 16). OMB No: 0915-0310. Expiration Date: 10/31/2022. Form released January, 2020.
Last Updated January, 2021. Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Center Number: ___ ___ ___ ___ ___
CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
☐ Midostaurin
☐ Nilotinib (AMN107, Tasigna)
☐ Nivolumab
☐ Pembrolizumab
☐ Pomalidomide
☐ Quizartinib
☐ Rituximab (Rituxan, MabThera)
☐ Sorafenib
☐ Sunitinib
☐ Thalidomide (Thalomid)
☐ Other systemic therapy
106. Specify other systemic therapy:
___________________________________
107. Specify other therapy:________________________________________________________
Relapse or Progression Post-HCT
Report if the recipient has experienced a clinical/hematologic relapse or progression post-HCT. If the relapse or progression was detected
in a previous reporting period indicate that and continue on. If the first clinical/hematologic relapse occurred since the date of last report,
indicate the date it was first detected in this reporting period.
108. Did the recipient experience a clinical/hematologic relapse or progression post-HCT?
☐ Yes
☐ No
109. Was the date of the first clinical/hematologic relapse or progression previously reported?
☐ Yes (only valid >day 100) - Go to question 119
☐ No
110. Date first seen: __ __ __ __ / __ __ / __ __
YYYY
MM
DD
Intervention for relapsed disease, persistent disease, or progressive disease
111. Was intervention given for relapsed, persistent or progressive disease since the date of last report?
☐ Yes
☐ No
112. Specify reason for which intervention was given
☐ Persistent disease
☐ Relapsed / progressive disease
113. Specify the method(s) of detection for which intervention was given (check all that apply)
☐ Clinical/hematologic
☐ Cytogenetic
☐ Disease specific molecular marker
☐ Flow cytometry
☐ Radiological (e.g. PET, MRI, CT)
CIBMTR Form 2450 revision 5 (page 14 of 16). OMB No: 0915-0310. Expiration Date: 10/31/2022. Form released January, 2020.
Last Updated January, 2021. Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Center Number: ___ ___ ___ ___ ___
CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
114. Date intervention started: __ __ __ __ / __ __ / __ __
YYYY
MM
DD
115. Specify therapy (check all that apply)
☐ Systemic therapy - Go to question 116
☐ Radiation - Go to question 119
☐ Cellular therapy - Go to question 119
☐ Blinded randomized trial - Go to question 119
☐ Other therapy - Go to question 118
116. Specify systemic therapy (check all that apply)
☐ Alemtuzumab (Campath)
☐ Azacytidine (Vidaza)
☐ Blinatumomab
☐ Bortezomib (Velcade)
☐ Bosutinib
☐ Carfilzomib
☐ Chemotherapy
☐ Dasatinib (Sprycel)
☐ Decitabine (Dacogen)
☐ Gemtuzumab (Mylotarg, anti-CD33)
☐ Gilteritinib
☐ Ibrutinib
☐ Imatinib mesylate (Gleevec)
☐ Ixazomib
☐ Lenalidomide (Revlimid)
☐ Lestaurtinib
☐ Midostaurin
☐ Nilotinib (AMN107, Tasigna)
☐ Nivolumab
☐ Pembrolizumab
☐ Pomalidomide
☐ Quizartinib
☐ Rituximab (Rituxan, MabThera)
☐ Sorafenib
☐ Sunitinib
☐ Thalidomide (Thalomid)
☐ Other systemic therapy
117. Specify other systemic therapy:
___________________________________
118. Specify other therapy:________________________________________________________
CIBMTR Form 2450 revision 5 (page 15 of 16). OMB No: 0915-0310. Expiration Date: 10/31/2022. Form released January, 2020.
Last Updated January, 2021. Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
CIBMTR Center Number: ___ ___ ___ ___ ___
CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___
Current Disease Status
119. What is the current disease status?
☐ Complete remission (CR) - Go to question 121
☐ Not in complete remission - Go to question 120
☐ Not evaluated - Go to signature line
120. Specify disease status if not in complete remission
☐ Disease detected
☐ No disease detected but incomplete evaluation to establish CR
121. Date of most recent disease assessment
☐ Known
☐ Unknown
122. Date of most recent disease assessment: __ __ __ __ / __ __ / __ __
YYYY
MM
DD
First Name:______________________________________________________________
Last Name:_______________________________________________________________
E-mail address:___________________________________________________________
Date: __ __ __ __ / __ __ / __ __
YYYY
MM
DD
CIBMTR Form 2450 revision 5 (page 16 of 16). OMB No: 0915-0310. Expiration Date: 10/31/2022. Form released January, 2020.
Last Updated January, 2021. Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.
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File Modified | 2021-08-06 |
File Created | 2020-08-06 |