4100: Cellular Therapy Essential Data Follow-Up Form

Transcription

1 4100: Cellular Therapy Essential Data Follow-Up Form Registry Use Only Sequence Number: Date Received: Key Fields CIBMTR Center Number: Event date: Visit: 100 day 6 months 1 year 2 years >2 years, Specify: CIBMTR Form 4100 revision 1 (page 1 of 12). Last Updated July, 2016.

2 Survival Questions: Date of actual contact with the recipient to determine medical status for this follow-up report: 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 Dead - Answers to subsequent questions should reflect clinical status between the date of last report and immediately prior to death 3. Primary cause of death: Recurrence / persistence / progression of disease for which the cellular therapy was performed Acute GVHD Chronic GVHD Graft rejection or failure Cytokine release syndrome Infection Infection, organism not identified Bacterial infection Fungal infection Viral infection Protozoal infection Other infection - Go to question 4 Pulmonary Idiopathic pneumonia syndrome (IPS) Pneumonitis due to Cytomegalovirus (CMV) Pneumonitis due to other virus Other pulmonary syndrome (excluding pulmonary hemorrhage) - Go to question 4 Diffuse alveolar damage (without hemorrhage) Adult respiratory distress syndrome (ARDS) (other than IPS) Organ failure (not due to GVHD or infection) Liver failure (not VOD) Veno-occlusive disease (VOD) / sinusoidal obstruction syndrome (SOS) Cardiac failure Pulmonary failure Central nervous system (CNS) failure Renal failure Gastrointestinal (GI) failure (not liver) Multiple organ failure - Go to question 4 Other organ failure - Go to question 4 Malignancy New malignancy (post-hct or post-cellular therapy) Prior malignancy (malignancy initially diagnosed prior to HCT or cellular therapy, other than the malignancy for which the HCT or cellular therapy was performed) Hemorrhage Pulmonary hemorrhage Diffuse alveolar hemorrhage (DAH) CIBMTR Form 4100 revision 1 (page 2 of 12). Last Updated July, 2016.

3 Intracranial hemorrhage Gastrointestinal hemorrhage Hemorrhagic cystitis Other hemorrhage - Go to question 4 Vascular Thromboembolic Disseminated intravascular coagulation (DIC) Thrombotic microangiopathy (TMA) (Thrombotic thrombocytopenic purpura (TTP)/ Hemolytic Uremic Syndrome (HUS)) Other vascular - Go to question 4 Other Accidental death Suicide Other cause - Go to question 4 4. Specify: 5. Contributing cause of death Recurrence / persistence / progression of disease for which the cellular therapy was performed Acute GVHD Chronic GVHD Graft rejection or failure Cytokine release syndrome Infection Infection, organism not identified Bacterial infection Fungal infection Viral infection Protozoal infection Other infection - Go to question 6 Pulmonary Idiopathic pneumonia syndrome (IPS) Pneumonitis due to Cytomegalovirus (CMV) Pneumonitis due to other virus Other pulmonary syndrome (excluding pulmonary hemorrhage) - Go to question 6 Diffuse alveolar damage (without hemorrhage) Adult respiratory distress syndrome (ARDS) (other than IPS) Organ failure (not due to GVHD or infection) Liver failure (not VOD) Veno-occlusive disease (VOD) / sinusoidal obstruction syndrome (SOS) Cardiac failure Pulmonary failure CIBMTR Form 4100 revision 1 (page 3 of 12). Last Updated July, 2016.

4 Central nervous system (CNS) failure Renal failure Gastrointestinal (GI) failure (not liver) Multiple organ failure - Go to question 6 Other organ failure Malignancy New malignancy (post-hct or post-cellular therapy) Prior malignancy (malignancy initially diagnosed prior to HCT or cellular therapy, other than the malignancy for which the HCT or cellular therapy was performed) Hemorrhage Pulmonary hemorrhage Diffuse alveolar hemorrhage (DAH) Intracranial hemorrhage Gastrointestinal hemorrhage Hemorrhagic cystitis Other hemorrhage - Go to question 6 Vascular Thromboembolic Disseminated intravascular coagulation (DIC) Thrombotic microangiopathy (TMA) (Thrombotic thrombocytopenic purpura (TTP)/ Hemolytic Uremic Syndrome (HUS)) Other vascular Other Accidental death Suicide Other cause - Go to question 6 6. Specify: Subsequent Cellular Infusions Questions: 7-16 All additional cellular therapy infusions given for the same indication per protocol require a separate infusion form. If a cellular therapy was administered for treatment of a different indication, in response to disease progression/no response, or was administration of a new product, a new Form 4000 (Pre-CTED) must be completed. 7. Has the recipient received a cellular therapy since the date of last report? 8. Specify the reason for which cellular therapy was given: Additional infusions given for the same indication per protocol - Go to question 9 Failure to respond or in response to disease assessment - Go to question 14 New indication - Go to question 14 Copy and complete question 9-13 to report infusions given since the date of last report CIBMTR Form 4100 revision 1 (page 4 of 12). Last Updated July, 2016.

5 9. Infusion date: 10. Specify the cell source: Autologous - Go to question 13 Allogeneic, unrelated - Go to question 12 Allogeneic, related - Go to question Specify the related donor type: Syngeneic (monozygotic twin) HLA-identical sibling (may include nonmonozygotic twin) HLA-matched other relative HLA-mismatched relative 12. Was this donor used for any prior cellular therapies? 13. Was the product genetically modified? - Go to question Date of cellular therapy: 15. Did the recipient receive an HCT since the date of last report? - Also complete CIBMTR HCT form Date of HCT: 17. What was the best response to the cellular therapy? Complete response rmalization of organ function Partial response Partial normalization of organ function response Disease progression or worsening of organ function - Go to question 20 Best Response to Cellular Therapy Questions: Was the date of best response previously reported? 19. Date response established: CIBMTR Form 4100 revision 1 (page 5 of 12). Last Updated July, 2016.

6 Disease Relapse or Progression Questions: Was a disease relapse or progression detected since the date of last report? 21. Date documented: New Malignancy, Lymphoproliferative or Myeloproliferative Disease / Disorder Questions: Report new malignancies that are different than the disease / disorder for which cellular therapy was performed. Do not include relapse, progression or transformation of the same disease subtype. 22. 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) Copy and complete questions 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. 23. Specify the new malignancy: Acute myeloid leukemia (AML / ANLL) Other leukemia Myelodysplastic syndrome (MDS) Myeloproliferative neoplasm (MPN) Myelodysplasia / myeloproliferative neoplasm (MDS / MPN) Hodgkin lymphoma n-hodgkin lymphoma Post-transplant lymphoproliferative disorder (PTLD) Clonal cytogenetic abnormality without leukemia or MDS Uncontrolled proliferation of donor cells without malignant transformation Breast cancer Central nervous system (CNS) malignancy (e.g. glioblastoma, astrocytoma) Gastrointestinal malignancy (e.g. colon, rectum, stomach, pancreas, intestine) Genitourinary malignancy (e.g. kidney, bladder, ovary, testicle, genitalia, uterus, cervix) Lung cancer Melanoma Basal cell skin malignancy Squamous cell skin malignancy Oropharyngeal cancer (e.g. tongue, buccal mucosa) Sarcoma Thyroid cancer Other new malignancy 24. Specify other new malignancy: 25. Date of diagnosis: 26. Was the new malignancy donor / cell product derived? t done CIBMTR Form 4100 revision 1 (page 6 of 12). Last Updated July, 2016.

7 Persistence of Cells Questions: This section pertains to the evaluation of persistence of a cellular product in the recipient. 27. Were tests performed to detect persistence of the cellular product since the date of last report? 28. Was persistence evaluated by molecular assay (PCR)? 29. Date sample collected: 30. Specify the cell source: Bone marrow Peripheral blood Tumor Other source 31. Specify other cell source: 32. Were the infused cells detected? 33. Was persistence evaluated by flow cytometry testing (immunophenotyping)? 34. Date sample collected: 35. Specify the cell source: Bone marrow Peripheral blood Tumor Other source 36. Specify other cell source: 37. Were the infused cells detected? 38. Was persistence evaluated by chimerism studies? 39. Date sample collected: 40. Specify the cell source: Bone marrow Peripheral blood Tumor Other source 41. Specify other cell source: 42. Were the infused cells detected? CIBMTR Form 4100 revision 1 (page 7 of 12). Last Updated July, 2016.

8 Cytokine Release Syndrome Questions: Did the recipient develop Cytokine Release Syndrome (CRS) since the date of last report? 44. Date of diagnosis: Specify if the recipient has developed any of the following since the date of last report: 45. Fevers ( F or 38 C) 46. Date of diagnosis: 47. Rigors 49. Malaise / fatigue 51. Anorexia 48. Date of diagnosis: 50. Date of diagnosis: 52. Date of diagnosis: 53. Myalgias / arthralgias 55. Nausea / vomiting 57. Other constitutional symptom 54. Date of diagnosis: 56. Date of diagnosis: 58. Date of diagnosis: 59. Specify other constitutional symptom: 60. Hypoxia requiring minimal supplemental oxygen (Fi02 40%) 62. Hypoxia requiring more than minimal supplemental oxygen (Fi02 >40%) 61. Date of diagnosis: 63. Date of diagnosis: CIBMTR Form 4100 revision 1 (page 8 of 12). Last Updated July, 2016.

9 64. Was mechanical ventilator support required? 65. Date started: 66. Hypotension requiring therapy 67. Date of diagnosis: Specify therapy given for hypotension: 68. Intravenous fluids 69. Vasopressor(s) 70. Specify the number of vasopressors used for therapy Other therapy 72. Specify other therapy: 73. Was hypotension controlled with therapy? 74. Has the recipient developed any grade 4 organ toxicity? 75. Liver 76. Date of diagnosis: 77. Lungs 79. Heart 81. Kidneys 78. Date of diagnosis: 80. Date of diagnosis: 82. Date of diagnosis: CIBMTR Form 4100 revision 1 (page 9 of 12). Last Updated July, 2016.

10 83. Gastrointestinal (GI) 84. Date of diagnosis: 85. Musculoskeletal 86. Date of diagnosis: 87. Neurologic 89. Other organ 88. Date of diagnosis: 90. Date of diagnosis: 91. Specify other organ: 92. Was therapy given? (for CRS) Specify therapy given for CRS: 93. Tocilizumab 94. Corticosteroids 95. Siltuximab 96. Other therapy 97. Specify other therapy: Specify the maximum lab results since the date of last report: 98. Interleukin-6 Known 101. Interferon gamma IFN-g Known 99. pg/ml 100. Date sample collected: 102. IU/mL 103. Date sample collected: CIBMTR Form 4100 revision 1 (page 10 of 12). Last Updated July, 2016.

11 104. Soluble interleukin-2 receptor α (sil2ra or soluble CD25) Known 105. u/ml 106. Date sample collected: 107. Total serum ferritin Known 108. ng/ml (μg/l) 109. Date sample collected: 110. C-reactive protein Known 111. mg/dl 112. Date sample collected: 113. Did cytokine release syndrome resolve? 114. Date resolved: Neurotoxicity Questions: Did neurotoxicity occur since the date of last report? 116. Date of diagnosis: Specify symptoms of neurotoxicity: 117. Visual hallucinations 118. Altered mental status 119. Tremors 120. Aphasia 121. Hemiparesis or other focal motor deficit 122. Seizure(s) 123. Other symptom 124. Specify other symptom: 125. Did neurotoxicity resolve? 126. Date resolved: CIBMTR Form 4100 revision 1 (page 11 of 12). Last Updated July, 2016.

12 Functional Status Questions: Was the recipient pregnant at any time in this reporting period? (Female only) - Go to First Name - Go to First Name 128. Was the recipient s female partner pregnant at any time in this reporting period? (Male only) - Go to First Name - Go to First Name 129. Was the recipient or recipient s partner still pregnant at the date of last contact? - Go to First Name 130. Specify the outcome of pregnancy: - Go to First Name Live birth Intrauterine fetal death Spontaneous abortion Elected abortion First Name: Last Name: address: Date: CIBMTR Form 4100 revision 1 (page 12 of 12). Last Updated July, 2016.