{"commentary":{"count":27,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":12,"x_thread":8,"podcast":7},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02614066\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"ZUMA-3","nct_id":"NCT02614066","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=zuma-3-nct02614066. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1250,"size":"standard","size_rule":"Standard: 13–40 commentary sources"},"registry":{"acronym":"ZUMA-3","arms":[{"description":"Participants with relapsed or refractory B-precursor acute lymphoblastic leukemia (r/r B-ALL) will receive conditioning chemotherapy (fludarabine 25 mg/m\\^2 intravenously \\[IV\\] over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\\^2 IV over 60 minutes on Day -2) following a single IV infusion of brexucabtagene autoleucel (KTE-X19) chimeric antigen receptor (CAR) transduced autologous T cells at a target dose of 2 x 10\\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \\> 100 kg, a maximum flat dose of 2 x 10\\^8 anti-CD19 CAR T cells/kg of body weight will be administered.","label":"Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg","type":"EXPERIMENTAL"},{"description":"Participants with r/r B-ALL will receive conditioning chemotherapy (fludarabine 25 mg/m\\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\\^2 IV over 60 minutes on Day -2) following a single IV infusion of brexucabtagene autoleucel CAR transduced autologous T cells at a target dose of 1 x 10\\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \\> 100 kg, a maximum flat dose of 1 x 10\\^8 anti-CD19 CAR T cells/kg of body weight will be administered.","label":"Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg","type":"EXPERIMENTAL"},{"description":"Participants with r/r B-ALL will receive conditioning chemotherapy (fludarabine 25 mg/m\\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\\^2 IV over 60 minutes on Day -2) following a single IV infusion of brexucabtagene autoleucel CAR transduced autologous T cells at a target dose of 0.5 x 10\\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \\> 100 kg, a maximum flat dose of 0.5 x 10\\^8 anti-CD19 CAR T cells/kg of body weight will be administered.","label":"Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg","type":"EXPERIMENTAL"},{"description":"Participants with r/r B-ALL will receive conditioning chemotherapy (fludarabine 25 mg/m\\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\\^2 IV over 60 minutes on Day -2) following a single IV infusion of brexucabtagene autoleucel CAR transduced autologous T cells at a target dose of 1 x 10\\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \\> 100 kg, a maximum flat dose of 1 x 10\\^8 anti-CD19 CAR T cells/kg of body weight will be administered.","label":"Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2023-11-03","type":"ACTUAL"},"conditions":["Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia"],"enrollment":{"count":125,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"brexucabtagene autoleucel","type":"BIOLOGICAL"},{"name":"Cyclophosphamide","type":"DRUG"},{"name":"Fludarabine","type":"DRUG"}],"last_update":"2024-11-19","lead_sponsor":"Kite, A Gilead Company","official_title":"A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-3)","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2022-07-23","type":"ACTUAL"},"primary_outcomes":[{"measure":"Phase 1: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)","timeFrame":"First infusion date of brexucabtagene autoleucel up to 28 days. Participants were evaluated in specified period but GR4 hematologic toxicity (specified in description) having onset in this period were further observed for 30 days for confirmation"},{"measure":"Phase 2: Overall Complete Remission (OCR) Rate (Complete Remission [CR]+ Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed Per Independent Review","timeFrame":"First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years"}],"references":[{"citation":"Oluwole OO, Shah BD, Baer MR, Bishop MR, Holmes H, Schiller GJ, et al. Outcomes of Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia Treated with Prior Blinatumomab in ZUMA-3, a Study of KTE-C19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy [Abstract S1569]. The 23rd European Hematology Association (EHA) Congress 2018 14-17 June; Stockholm, Sweden.","pmid":null,"type":"RESULT"},{"citation":"Sabatino M, Choi K, Chiruvolu V, Better M. Production of Anti-CD19 CAR T Cells for ZUMA-3 and -4: Phase 1/2 Multicenter Studies Evaluating KTE-C19 in Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (R/R ALL) [Abstract 711]. Blood 2016;128 (22):1227.","pmid":null,"type":"RESULT"},{"citation":"Shah B, Castro J, Gokbuget N, Kersten MJ, Hagenbeek T, Wierda W, et al. ZUMA-3: A Phase 1/2 Multi-center Study Evaluating the Safety and Efficacy of KTE-C19 Anti-CD19 CAR T Cells in Adult Subjects with Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia (r/r ALL). European Society for Medical Oncology (ESMO) Congress 2016;Abstract 3713.","pmid":null,"type":"RESULT"},{"citation":"Shah B, Huynh V, Sender LS, Lee DW, Castro JE, Wierda WG, et al. High Rates of Minimal Residual Disease-Negative (MRD-) Complete Responses (CR) in Adult and Pediatric and Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (R/R ALL) Treated With KTE-C19 (Anti-CD19 Chimeric Antigen Receptor [CAR] T Cells): Preliminary Results of the ZUMA-3 and ZUMA-4 Trials. Blood 2016;128 (22):2803.","pmid":null,"type":"RESULT"},{"citation":"Shah B, Stock W, Wierda W, Topp M, Kersten MJ, Houot R, et al. KTE-C19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T cell Therapy in Adult Patients (Pts) With Relapsed/ Refractory Acute Lymphoblastic Leukemia (R/R ALL) in the ZUMA-3 Trial: Preliminary Results of Novel Safety Interventions [Abstract ALL-025]. Clinical lymphoma, myeloma & leukemia 2017;17:S253.","pmid":null,"type":"RESULT"},{"citation":"Shah B, Stock W, Wierda W, Topp MS, Kersten MJ, Houot R, et al. Preliminary Results of Novel Safety Interventions in Adult Patients (Pts) With Relapsed/Refractory Acute Lymphoblastic Leukemia (R/R ALL) in the ZUMA-3 Trial. European Society for Medical Oncology (ESMO) Congress 2017.","pmid":null,"type":"RESULT"},{"citation":"Shah B, Wierda WG, Schiller GJ, Bishop MR, Castro JE, Sabatino M, et al. KTE-C19 Chimeric Antigen Receptor (CAR) T Cell Therapy in Adults with High-Burden Relapsed/Refractory Acute Lymphoblastic Leukemia (R/R ALL): Updated Results from Phase 1/2 of ZUMA-3 [Abstract P523]. The 22nd European Hematology Association (EHA) Congress 2017 22-25 June; Madrid, Spain.","pmid":null,"type":"RESULT"},{"citation":"Shah BD, Bishop MR, Oluwole OO, Logan A, Baer MR, Donnellan WB, et al. End of Phase I Results of ZUMA-3, A Phase 1/2 Study of KTE-X19, Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, in Adult Patients (pts) with Relapsed/Refractory (R/R) Acute Lymphoblastic Leukemia (ALL) [Abstract]. J Clin Oncol 2019;37 (15):7006.","pmid":null,"type":"RESULT"},{"citation":"Shah BD, Bishop MR, Oluwole OO, Logan AC, Baer MR, Donnellan WB, et al. KTE-X19, an Anti-CD19 Chimeric Antigen Receptor T Cell Therapy, in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia: End of Phase 1 Results of ZUMA-3 [Abstract PS945]. HemaSphere 2019;3 (S1):426.","pmid":null,"type":"RESULT"},{"citation":"Shah BD, Oluwole OO, Baer MR, Bishop MR, Holmes H, Schiller GJ, et al. KTE-C19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, in Adult Patients with Relapsed/ Refractory Acute Lymphoblastic Leukemia (R/R ALL): Outcomes in Patients Who Were Treated with Prior Blinatumomab in ZUMA-3 [Abstract ALL-128]. Clinical lymphoma, myeloma & leukemia 2018;18 (Supplement 1):S184.","pmid":null,"type":"RESULT"},{"citation":"Shah BD, Oluwole OO, Baer MR, Bishop MR, Holmes H, Schiller GJ, et al. Outcomes of Patients Treated With Prior Blinatumomab in ZUMA-3, a Study of KTE-C19, an Anti-CD19 Chimeric Antigen Receptor T Cell Therapy, in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia. ASCO; 2018 01-05 June; Chicago, IL.","pmid":null,"type":"RESULT"},{"citation":"Shah BD, Stock W, Wierda WG, Oluwole O, Holmes H, Schiller GJ, et al. Phase 1 Results of ZUMA-3: KTE-C19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia (R/R ALL) [Abstract 612]. Blood 2017;130 (Supplement 1):888.","pmid":null,"type":"RESULT"},{"citation":"Shah BD, Wierda WG, Schiller GJ, Bishop MR, Castro JE, Sabatino M, et al. Updated results from ZUMA- 3, a phase 1/2 study of KTE-C19 chimeric antigen receptor (CAR) T cell therapy, in adults with high-burden relapsed/refractory acute lymphoblastic leukemia (R/R ALL) [Abstract 3024]. American Society of Clinical Oncology (ASCO) Annual Meeting; 2017 02-06 June; Chicago, Illinois.","pmid":null,"type":"RESULT"},{"citation":"Wierda WG, Bishop MR, Oluwole O, Logan AC, Baer MR, Donnellan WB, et al. Updated Phase 1 Results of Zuma-3: Kte-X19, an Anti-CD19 Chimeric Antigen Receptor T Cell Therapy, in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia [Abstract 256]. Biol Blood Marrow Transplant 2019;25 (3):S185.","pmid":null,"type":"RESULT"},{"citation":"Wierda WG, Bishop MR, Oluwole OO, Logan AC, Baer MR, Donnellan WB, et al. Updated Phase 1 Results of Zuma-3: Kte-C19, an Anti-CD19 Chimeric Antigen Receptor T Cell Therapy, in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia [Abstract]. Blood 2018;132 (Supplement 1):897.","pmid":null,"type":"RESULT"},{"citation":"Shah BD, Bishop MR, Oluwole OO, Logan AC, Baer MR, Donnellan WB, O'Dwyer KM, Holmes H, Arellano ML, Ghobadi A, Pagel JM, Lin Y, Cassaday RD, Park JH, Abedi M, Castro JE, DeAngelo DJ, Malone AK, Mawad R, Schiller GJ, Rossi JM, Bot A, Shen T, Goyal L, Jain RK, Vezan R, Wierda WG. KTE-X19 anti-CD19 CAR T-cell therapy in adult relapsed/refractory acute lymphoblastic leukemia: ZUMA-3 phase 1 results. Blood. 2021 Jul 8;138(1):11-22. doi: 10.1182/blood.2020009098.","pmid":"33827116","type":"RESULT"},{"citation":"Shah BD, Ghobadi A, Oluwole OO, Logan AC, Boissel N, Cassaday RD, Leguay T, Bishop MR, Topp MS, Tzachanis D, O'Dwyer KM, Arellano ML, Lin Y, Baer MR, Schiller GJ, Park JH, Subklewe M, Abedi M, Minnema MC, Wierda WG, DeAngelo DJ, Stiff P, Jeyakumar D, Feng C, Dong J, Shen T, Milletti F, Rossi JM, Vezan R, Masouleh BK, Houot R. KTE-X19 for relapsed or refractory adult B-cell acute lymphoblastic leukaemia: phase 2 results of the single-arm, open-label, multicentre ZUMA-3 study. Lancet. 2021 Aug 7;398(10299):491-502. doi: 10.1016/S0140-6736(21)01222-8. Epub 2021 Jun 4.","pmid":"34097852","type":"RESULT"},{"citation":"Shah BD, Ghobadi A, Oluwole OO, Logan AC, Boissel N, Cassaday RD, Leguay T, Bishop MR, Topp MS, Tzachanis D, O'Dwyer KM, Arellano ML, Lin Y, Baer MR, Schiller GJ, Park JH, Subklewe M, Abedi M, Minnema MC, Wierda WG, DeAngelo DJ, Stiff P, Jeyakumar D, Dong J, Adhikary S, Zhou L, Schuberth PC, Faghmous I, Masouleh BK, Houot R. Two-year follow-up of KTE-X19 in patients with relapsed or refractory adult B-cell acute lymphoblastic leukemia in ZUMA-3 and its contextualization with SCHOLAR-3, an external historical control study. J Hematol Oncol. 2022 Dec 10;15(1):170. doi: 10.1186/s13045-022-01379-0.","pmid":"36494725","type":"DERIVED"},{"citation":"Shah BD, Smith NJ, Feng C, Jeyakumar S, Castaigne JG, Faghmous I, Masouleh BK, Malone DC, Bishop MR. Cost-Effectiveness of KTE-X19 for Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia in the United States. Adv Ther. 2022 Aug;39(8):3678-3695. doi: 10.1007/s12325-022-02201-6. Epub 2022 Jun 21.","pmid":"35727476","type":"DERIVED"}],"start_date":{"date":"2016-03-07","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3)","url":"https://clinicaltrials.gov/study/NCT02614066"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/zuma-3-nct02614066"}