4000: Cellular Therapy Essential Data Pre-Infusion Form

Transcription

1 4000: Cellular Therapy Essential Data Pre-Infusion Form Registry Use Only Sequence Number: Date Received: Key Fields CIBMTR Center Number: Event date: / / CIBMTR Form 4000 revision 3 (page 1 of 19). Last Updated July, 2016.

2 Recipient Data Questions: 1-8 This form must be completed for all recipients of non-hct cellular products. For recipients of hematopoietic stem cell transplants, complete a form 2400 Pre-Transplant Essential Data. This form reflects baseline recipient data for one course of cellular therapy. 1. Has the recipient signed an IRB / Ethics Committee-approved consent form for submitting research data to the CIBMTR? (patient consented) (patient declined) t approached t applicable 2. Date form was signed: / / 3. Is the recipient participating in a cellular therapy clinical trial? 4. Study sponsor: BMT CTN - Go to question 7 RCI BMT - Go to question 7 USIDNET - Go to question 8 COG - Go to question 8 Corporate / Industry - Go to question 5 Other - Go to question 6 5. Specify corporate / industry sponsor name: - Go to question 8 6. Specify other sponsor: - Go to question 8 7. Study ID Number: 8. Specify the ClinicalTrials.gov identification number: Copy and complete questions 4-8 to report participation in more than one clinical trial Cellular Therapy and HCT History Questions: Is this the first application of cellular therapy (non-hct)? - Go to question 19 (recipient has previously been treated using cellular therapy) 10. Were all prior cellular therapies (non-hct) reported to the CIBMTR? - Go to question 19 - Go to question 11 Unknown - Go to question Specify the number of prior cellular therapies: Copy and complete questions to report all prior cellular therapies that have not yet been reported to the CIBMTR 12. Date of the prior cellular therapy: / / CIBMTR Form 4000 revision 3 (page 2 of 19). Last Updated July, 2016.

3 13. Was the indication for the prior cellular therapy the same as the current cellular therapy? 14. Specify the indication for the prior cellular therapy: Promote stem cell engraftment (e.g. co-infusion with HCT) Suboptimal donor chimerism (post-hct) Immune reconstitution (post-hct) GVHD prophylaxis (with HCT) GVHD treatment (post-hct) Prevent disease relapse (post-hct) Relapsed, persistent or progressive disease (post-hct) Infection prophylaxis Infection treatment B cell lymphoproliferative disorder (PTLD, EBV lymphoma) Autoimmune disease Cardiovascular disease Musculoskeletal disorder Neurologic disease Ocular disease Pulmonary disease Solid tumor Malignant hematologic disorder n-malignant disorder Other indication 15. Specify other indication: 16. Was the cellular therapy performed at a different institution? Specify the institution that performed the prior cellular therapy: 17. Name: City: State: Country: 18. What was the cell source for the prior cellular therapy? Autologous Allogeneic, unrelated Allogeneic, related CIBMTR Form 4000 revision 3 (page 3 of 19). Last Updated July, 2016.

4 19. Has the recipient ever had a prior HCT? 20. Were all prior HCTs reported to the CIBMTR? - Go to question 28 Copy and complete questions to report all prior HCTs that have not yet been reported to the CIBMTR: 21. Date of the prior HCT: / / 22. Was the HCT performed at a different institution? Specify the institution that performed the prior HCT: 23. Name: Specify the HSC source(s) for the prior HCT: City: State: Country: 24. Autologous 25. Allogeneic, unrelated 26. Allogeneic, related 27. Syngeneic 28. Is a subsequent HCT part of the overall treatment protocol? 29. Specify the HCT type: Autologous Allogeneic 30. Specify the circumstances in which the subsequent HCT will be performed: Regardless of response to cellular therapy Only if the patient responds to cellular therapy Only if the patient fails to respond or has an incomplete response Planned Infusions in First 100 Days Questions: Copy and complete questions to report all infusions to be given within the first 100 days, as part of this course of cellular therapy. 31. Planned infusion date: / / 32. Specify the cell source: Autologous - Go to question 35 Allogeneic, related Allogeneic, unrelated 33. Specify the related donor type: Syngeneic (monozygotic twin) HLA-identical sibling (may include non-monozygotic twin) HLA-matched other relative HLA-mismatched relative 34. Was this donor used for any prior cellular therapies? 35. Was the product genetically modified? CIBMTR Form 4000 revision 3 (page 4 of 19). Last Updated July, 2016.

5 Indication for Cellular Therapy Questions: What was the indication for performing treatment with cellular therapy? Promote stem cell engraftment (e.g. co-infusion with HCT) - Go to question 116 Suboptimal donor chimerism (post-hct) - Go to question 116 Immune reconstitution (post-hct) - Go to question 116 GVHD prophylaxis (with HCT) - Go to question 116 GVHD treatment (post-hct) - Go to question 116 Prevent disease relapse (post-hct) - Go to question 116 Relapsed, persistent or progressive disease (post-hct) - Go to question 90 Infection prophylaxis - Go to question 37 Infection treatment - Go to question 37 B cell lymphoproliferative disorder (PTLD, EBV lymphoma) - Go to question 37 Autoimmune disease - Go to question 37 Cardiovascular disease - Go to question 37 Musculoskeletal disorder - Go to question 37 Neurologic disease - Go to question 37 Ocular disease - Go to question 37 Pulmonary disease - Go to question 37 Solid tumor - Go to question 37 Malignant hematologic disorder - Go to question 37 n-malignant disorder - Go to question 37 Other indication - Go to question Date of diagnosis: / / Infection prophylaxis - Go to question 116 Infection treatment - Go to question 83 B cell lymphoproliferative disorder (PTLD, EBV lymphoma) - Go to question 116 Autoimmune disease - Go to question 38 Cardiovascular disease - Go to question 41 Musculoskeletal disorder - Go to question 44 Neurologic disease - Go to question 46 Ocular disease - Go to question 80 Pulmonary disease - Go to question 81 Solid tumor - Go to question 48 Malignant hematologic disorder - Go to question 50 Non-malignant disorder - Go to question 64 Other indication - Go to question Specify autoimmune disease: Crohn s disease (649) - Go to questions 116 Ulcerative colitis (650) - Go to questions 116 Other autoimmune bowel disorder (651) 39. Specify other autoimmune bowel disorder: - Go to questions 116 Diabetes mellitus type I (660) - Go to questions 116 Rheumatoid arthritis (603) - Go to questions 116 Systemic lupus erythematous (605) - Go to questions 116 Systemic sclerosis (607) - Go to questions 116 CIBMTR Form 4000 revision 3 (page 5 of 19). Last Updated July, 2016.

6 Other autoimmune disease (629) 40. Specify other autoimmune disease: - Go to questions 116 Cardiovascular disease 41. Specify cardiovascular disease: AMI, acute myocardial infarction (701) - Go to questions 116 Chronic coronary artery disease (ischemic, cardiomyopathy) (702) - Go to questions 116 Heart failure (non-ischemic etiology) (703) - Go to questions 116 Other cardiovascular disease (709) 42. Specify other cardiovascular disease: - Go to questions 116 Limb ischemia (710) - Go to questions 116 Thromboangitis obliterans (711) - Go to questions 116 Other peripheral vascular disease (719) 43. Specify other peripheral vascular disease: - Go to questions 116 Musculoskeletal 44. Specify musculoskeletal disorder: Avascular necrosis of femoral head (721) - Go to questions 116 Osteoarthritis (722) - Go to questions 116 Osteogenesis imperfecta (723) - Go to questions 116 Traumatic joint injury (724) - Go to questions 116 Other musculoskeletal disorder (729) 45. Specify other musculoskeletal disorder: - Go to questions 116 Neurologic Disease 46. Specify neurologic disease: Acute cerebral vascular ischemia (731) - Go to questions 116 ALS, amiotrophic lateral sclerosis (732) - Go to questions 116 Parkinson disease (733) - Go to questions 116 Spinal cord injury (734) - Go to questions 116 Cerebral palsy (753) - Go to questions 116 Congenital hydrocephalus (754) - Go to questions 116 Multiple sclerosis (602) - Go to questions 116 Myasthenia gravis (601) - Go to questions 116 Other neurologic disease (749) 47. Specify other neurologic disease: - Go to questions 116 CIBMTR Form 4000 revision 3 (page 6 of 19). Last Updated July, 2016.

7 Solid Tumor 48. Specify solid tumor classification: Breast cancer (250) - Go to questions 90 Lung, small cell (202) - Go to questions 90 Lung, non-small cell (203) - Go to questions 90 Lung, not otherwise specified (230) - Go to questions 90 Testicular (210) - Go to questions 90 Ovarian (epithelial) (214) - Go to questions 90 Germ cell tumor, extragonadal (225) - Go to questions 90 Bone sarcoma (excluding Ewing family tumors) (273) - Go to questions 90 Ewing family tumors of bone (including PNET) (275) - Go to questions 90 Ewing family tumors, extraosseous (including PNET) (276) - Go to questions 90 Fibrosarcoma (244) - Go to questions 90 Hemangiosarcoma (246) - Go to questions 90 Leiomyosarcoma (242) - Go to questions 90 Liposarcoma (243) - Go to questions 90 Lymphangio sarcoma (247) - Go to questions 90 Neurogenic sarcoma (248) - Go to questions 90 Rhabdomyosarcoma (232) - Go to questions 90 Synovial sarcoma (245) - Go to questions 90 Soft tissue sarcoma (excluding Ewing family tumors) (274) - Go to questions 90 Central nervous system tumor, including CNS PNET (220) - Go to questions 90 Medulloblastoma (226) - Go to questions 90 Neuroblastoma (222) - Go to questions 90 Head / neck (201) - Go to questions90 Mediastinal neoplasm (204) - Go to questions 90 Colorectal (228) - Go to questions 90 Gastric (229) - Go to questions 90 Pancreatic (206) - Go to questions 90 Hepatobiliary (207) - Go to questions 90 Prostate (209) - Go to questions 90 External genitalia (211) - Go to questions 90 Cervical (212) - Go to questions 90 Uterine (213) - Go to questions 90 Vaginal (215) - Go to questions 90 Melanoma (219) - Go to questions 90 Wilm tumor (221) - Go to questions 90 Retinoblastoma (223) - Go to questions 90 Thymoma (231) - Go to questions 90 Renal cell (208) - Go to questions 90 Other solid tumor (269) 49. Specify other solid tumor: - Go to questions 90 CIBMTR Form 4000 revision 3 (page 7 of 19). Last Updated July, 2016.

8 Malignant Hematologic Disorders 50. Specify the malignant hematologic disorder: Acute myelogenous leukemia (AML) (10) - Go to question 52 Acute lymphoblastic leukemia (ALL) (20) - Go to question 53 Other acute leukemia (80) - Go to question 54 Chronic myelogenous leukemia (CML) (40) - Go to question 56 Myelodysplastic (MDS) / myeloproliferative (MPN) diseases (50) (If recipient has transformed to AML, indicate AML as the primary disease) - Go to question 57 Chronic lymphocytic leukemia (71) - Go to question 58 Hodgkin lymphoma (150) - Go to question 59 n-hodgkin lymphoma (100) - Go to question 60 Multiple myeloma / plasma cell disorder (PCD) (170) - Go to question 62 Other malignant hematologic disorder (791) 51. Specify other malignant hematologic disorder: - Go to questions Specify the AML classification: - Go to question 90 AML with t(9;11) (p22;q23); MLLT 3-MLL (5) AML with t(6;9) (p23;q34); DEK-NUP214 (6) AML with inv(3) (q21;q26.2) or t(3;3) (q21;q26.2); RPN1-EVI1 (7) AML (megakaryoblastic) with t(1;22) (p13;q13); RBM15-MKL1 (8) AML with t(8;21); (q22; q22); RUNX1-RUNX1T1 (281) AML with inv(16); (p13;1q22) or t(16;16) (p13.1; q22); CBFB/MYH11 (282) APL with t(15;17); (q22;q12); PML-RARA (283) 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) Myeloid sarcoma (295) Blastic plasmacytoid dendritic cell neoplasm (296) AML or ANLL, not otherwise specified (280) AML, minimally differentiated (M0) (286) AML without maturation (M1) (287) AML with maturation (M2) (288) Acute myelomonocytic leukemia (M4) (289) Acute monoblastic / acute monocytic leukemia (M5) (290) Acute erythroid leukemia (erythroid / myeloid and pure erythroleukemia) (M6) (291) Acute megakaryoblastic leukemia (M7) (292) Acute basophilic leukemia (293) Acute panmyelosis with myelofibrosis (294) CIBMTR Form 4000 revision 3 (page 8 of 19). Last Updated July, 2016.

9 53. Specify ALL classification: - Go to question 90 t(9;22)(q34;q11.2); BCR/ABL1 (192) t(v;11q23); MLL rearranged (193) t(1;19)(q23;p13.3) E2A-PBX1 (194) t(12;21) (p13;q22); TEL-AML1 (195) t(5;14) (q31;q32); IL3-IGH (81) Hyperdiploidy (51-65 chromosomes) (82) Hypodiploidy (<45 chromosomes) (83) B-cell ALL, NOS (L1/L2) (191) T-cell lymphoblastic leukemia / lymphoma (Precursor T-cell ALL) (196) ALL, NOS (190) 54. Specify other acute leukemia classification: Acute undifferentiated leukemia (31) - Go to question 90 Biphenotypic, bilineage or hybrid leukemia (32) - Go to question 90 Acute mast cell leukemia (33) - Go to question 90 Other acute leukemia (89) 55. Specify other acute leukemia: - Go to question Specify CML classification: - Go to question 90 Ph+ / bcr+ (41) Ph+ / bcr- (42) Ph+ / bcr unknown (43) Ph- / bcr+ (44) Ph unknown / bcr+ (47) 57. What was the MDS / MPN subtype? - Go to question 90 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 anemia with excess blasts-2 (RAEB-2) (62) 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) Myelodysplastic syndrome (MDS), unclassifiable (50) Chronic neutrophilic leukemia (165) Chronic eosinophilic leukemia, NOS (166) Essential thrombocythemia (includes primary thrombocytosis, idiopathic thrombocytosis, hemorrhagic thrombocythemia) (58) CIBMTR Form 4000 revision 3 (page 9 of 19). Last Updated July, 2016.

10 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) Atypical chronic myeloid leukemia, Ph-/bcr/abl- {CML, NOS} (45) Atypical chronic myeloid leukemia, Ph-/bcr unknown {CML, NOS} (46) Atypical chronic myeloid leukemia, Ph unknown/bcr- {CML, NOS} (48) Atypical chronic myeloid leukemia, Ph unknown/bcr unknown {CML, NOS} (49) Myelodysplastic / myeloproliferative neoplasm, unclassifiable (69) 58. Specify the CLL classification: Chronic lymphocytic leukemia (CLL), NOS (34) - Go to question 90 Chronic lymphocytic leukemia (CLL), B-cell / small lymphocytic lymphoma (SLL) (71) - Go to question Specify Hodgkin lymphoma classification: - Go to question 90 dular lymphocyte predominant Hodgkin lymphoma (155) Lymphocyte-rich (151) dular sclerosis (152) Mixed cellularity (153) Lymphocyte depleted (154) Hodgkin lymphoma, NOS (150) 60. 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) dal 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) CIBMTR Form 4000 revision 3 (page 10 of 19). Last Updated July, 2016.

11 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 61 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 Specify other lymphoma: - Go to question Specify the multiple myeloma/plasma cell disorder (PCD) classification: Multiple myeloma-lgg (181) - Go to questions 90 Multiple myeloma-lga (182) - Go to questions 90 Multiple myeloma-lgd (183) - Go to questions 90 Multiple myeloma-lge (184) - Go to question 90 Multiple myeloma-lgm (not Waldenstrom macroglobulinemia) (185) - Go to questions 90 Multiple myeloma-light chain only (186) - Go to questions 90 Multiple myeloma-non-secretory (187) - Go to questions 90 Plasma cell leukemia (172) - Go to question 90 Solitary plasmacytoma (no evidence of myeloma) (175) - Go to question 90 Amyloidosis (174) - Go to question 90 Osteosclerotic myeloma / POEMS syndrome (176) - Go to questions 90 Light chain deposition disease (177) - Go to questions 90 CIBMTR Form 4000 revision 3 (page 11 of 19). Last Updated July, 2016.

12 Other plasma cell disorder (179) 63. Specify other plasma cell disorder: Non-Malignant Disorders 64. Specify the non-malignant disorder: Severe aplastic anemia (300)(If the recipient developed MDS or AML, indicate MDS or AML as the primary disease) - Go to question 65 Inherited abnormalities of erythrocyte differentiation or function (310) - Go to question 67 Disorders of the immune system (400) - Go to question 70 Inherited abnormalities of platelets (500) - Go to question 73 Inherited disorders of metabolism (520) - Go to question 75 Histiocytic disorders (570) - Go to question 77 Hemophilia A (740) - Go to question 116 Hemophilia B (741) - Go to question 116 Other non-malignant disorder (792) - Go to question 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) 66. Specify other acquired cytopenic syndrome: - Go to question Specify the inherited abnormalities of erythrocyte differentiation or function classification: Paroxysmal nocturnal hemoglobinuria (PNH) (56) Shwachman-Diamond (305) Diamond-Blackfan anemia (pure red cell aplasia) (312) Other constitutional anemia (319) 68. Specify other constitutional anemia: - Go to question 116 Fanconi anemia (311) (If the recipient developed MDS or AML, indicate MDS or AML as the primary disease). Sickle thalassemia (355) CIBMTR Form 4000 revision 3 (page 12 of 19). Last Updated July, 2016.

13 Sickle cell disease (356) Beta thalassemia major (357) Other hemoglobinopathy (359) 69. Specify other hemoglobinopathy: - Go to question 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) 71. Specify other SCID: - Go to question 116 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) Cartilage-hair hypoplasia (462) CD40 ligand deficiency (464) Other immunodeficiencies (479) 72. Specify other immunodeficiency: - Go to question 116 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) CIBMTR Form 4000 revision 3 (page 13 of 19). Last Updated July, 2016.

14 73. Specify inherited abnormalities of platelets classification: Congenital amegakaryocytosis / congenital thrombocytopenia (501) Glanzmann thrombasthenia (502) Other inherited platelet abnormality (509) 74. Specify other inherited platelet abnormality: - Go to question Specify inherited disorders of metabolism classification: Osteopetrosis (malignant infantile osteopetrosis) (521) Metachromatic leukodystrophy (MLD) (542) Adrenoleukodystrophy (ALD) (543) Krabbe disease (globoid leukodystrophy) (544) Lesch-Nyhan (HGPRT deficiency) (522) Neuronal ceroid lipofuscinosis (Batten disease) (523) 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) Gaucher disease (541) Niemann-Pick disease (545) I-cell disease (546) Wolman disease (547) Glucose storage disease (548) Mucolipidoses, not otherwise specified (540) Aspartyl glucosaminidase (561) Fucosidosis (562) Mannosidosis (563) Polysaccharide hydrolase abnormality, not otherwise specified (560) Other inherited metabolic disorder (529) 76. Specify other inherited metabolic disorder: - Go to question 116 Inherited metabolic disorder, not otherwise specified (520) CIBMTR Form 4000 revision 3 (page 14 of 19). Last Updated July, 2016.

15 77. Specify histiocytic disorder classification: 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 Specify other histiocytic disorder: - Go to question 116 Histiocytic disorder, not otherwise specified (570) 79. Specify other non-malignant disorder: - Go to question 116 Ocular 80. Specify ocular disease: - Go to question 116 Pulmonary 81. Specify pulmonary disease: - Go to question 116 Other 82. Specify other indication: - Go to question 116 Infection Questions: Specify organism code(s): Specify other organism: - Go to question Aspergillus, NOS 211 Aspergillus flavus 212 Aspergillus fumigatus 213 Aspergillus niger 215 Aspergillus terreus 214 Aspergillus ustus 270 Blastomyces (dermatitidis) 201 Candida albicans 208 Candida non-albicans 271 Coccidioides (all species) 222 Cryptococcus gattii 221 Cryptococcus neoformans 230 Fusarium (all species) CIBMTR Form 4000 revision 3 (page 15 of 19). Last Updated July, 2016.

16 261 Histoplasma (capsulatum) 241 Mucorales (all species) 260 Pneumocystis (PCP / PJP) 242 Rhizopus (all species) 272 Scedosporium (all species) 240 Zygomycetes, NOS 503 Suspected fungal infection 304 Adenovirus 341 BK Virus 344 Coronavirus 303 Cytomegalovirus (CMV) 347 Chikaugunya virus 346 Dengue Virus 325 Enterovirus (ECHO, Coxsackie) 327 Enterovirus D68 (EV-D68) 326 Enterovirus (polio) 328 Enterovirus NOS 318 Epstein-Barr Virus (EBV) 306 Hepatitis A Virus 307 Hepatitis B Virus 308 Hepatitis C Virus 340 Hepatitis E 301 Herpes Simplex Virus (HSV) 317 Human herpesvirus 6 (HHV-6) 309 Human Immunodeficiency Virus 1 or Human metapneumovirus 322 Human Papillomavirus (HPV) 349 Human T-lymphotropic Virus 1 or Influenza, NOS 323 Influenza A Virus 324 Influenza B Virus 342 JC Virus (Progressive Multifocal Leukoencephalopathy (PML)) 311 Measles Virus (Rubeola) 312 Mumps Virus 345 Norovirus 316 Human Parainfluenza Virus (all species) 314 Respiratory Syncytial Virus (RSV) 321 Rhinovirus (all species) 320 Rotavirus (all species) 315 Rubella Virus 302 Varicella Virus 348 West Nile Virus (WNV) 777 Other organism CIBMTR Form 4000 revision 3 (page 16 of 19). Last Updated July, 2016.

17 Disease assessment at Last Evaluation Prior to Cellular Therapy Questions: Specify the method(s) of disease detection below. For each method used, if the result was positive report the first date the disease was detected; if the result was negative report the last date the method was used prior to cellular therapy. 90. Was the disease assessed prior to the cellular therapy? 91. Was the disease status assessed by molecular testing (e.g. PCR)? t applicable 92. Date sample collected: / / 93. Was disease detected? 94. Was the status considered a disease relapse or progression? 95. Was the disease status assessed via flow cytometry? (immunophenotyping) t applicable 96. Date sample collected: / / 97. Was disease detected? 98. Was the status considered a disease relapse or progression? 99. Was the disease status assessed by cytogenetic testing (karyotyping or FISH)? t applicable 100. Was the disease status assessed via karyotyping? t applicable 101. Date sample collected: / / 102. Was disease detected? 103. Was the status considered a disease relapse or progression? CIBMTR Form 4000 revision 3 (page 17 of 19). Last Updated July, 2016.

18 104. Was the disease status assessed via FISH? t applicable 105. Date sample collected: / / 106. Was disease detected? 107. Was the status considered a disease relapse or progression? 108. Was the disease status assessed by radiological assessment? (e.g. PET, MRI, CT) t applicable 109. Date assessed: / / 110. Was disease detected? 111. Was the disease status assessed by clinical / hematologic assessment? 112. Date assessed: / / 113. Was disease detected? 114. What was the recipient s disease status immediately prior to the cellular therapy? Complete remission (CR) t in complete remission 115. Date assessed: / / 116. Was systemic therapy given immediately prior to cellular therapy as part of the cellular therapy protocol? Therapy Prior to Cellular Therapy Questions: Date started: / / 118. Specify the reason for which the systemic therapy was given per protocol: Lympho-depleting therapy Go to question 120 Reduction of tumor burden Go to question 120 Other reason 119. Specify other reason: CIBMTR Form 4000 revision 3 (page 18 of 19). Last Updated July, 2016.

19 Functional Status Questions: Specify the functional status of the recipient immediately prior to the cellular therapy: 120. What scale was used to determine the recipient s functional status prior to the cellular therapy: Karnofsky (recipient age 16 years) 121. Karnofsky Scale (recipient age 16 years): 100 Normal; no complaints; no evidence of disease - Go to First Name 90 Able to carry on normal activity - Go to First Name 80 Normal activity with effort - Go to First Name 70 Cares for self; unable to carry on normal activity or to do active work - Go to First Name 60 Requires occasional assistance but is able to care for most needs - Go to First Name 50 Requires considerable assistance and frequent medical care - Go to First Name 40 Disabled; requires special care and assistance - Go to First Name 30 Severely disabled; hospitalization indicated, although death not imminent - Go to First Name 20 Very sick; hospitalization necessary - Go to First Name 10 Moribund; fatal process progressing rapidly - Go to First Name Lansky (recipient age 1 year and < 16 years) 122. Lansky Scale (recipient are 1 year and < 16 years): 100 Fully active 90 Minor restriction in physically strenuous play 80 Restricted in strenuous play, tires more easily, otherwise active 70 Both greater restrictions of, and less time spent in, active play 60 Ambulatory up to 50% of time, limited active play with assistance / supervision 50 Considerable assistance required for any active play; fully able to engage in quiet play 40 Able to initiate quiet activities 30 Needs considerable assistance for quiet activity 20 Limited to very passive activity initiated by others (e.g., TV) 10 Completely disabled, not even passive play First Name: Last Name: address: Date: / / CIBMTR Form 4000 revision 3 (page 19 of 19). Last Updated July, 2016.