{"commentary":{"count":50,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":21,"podcast":19,"x_thread":10},"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\": \"NCT03761056\", \"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-12","nct_id":"NCT03761056","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=zuma-12-nct03761056. 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":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":"ZUMA-12","arms":[{"description":"Participants will receive cyclophosphamide 500 mg/m\\^2/day intravenously (IV) and fludarabine 30 mg/m\\^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\\^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10\\^8 anti-CD19 CAR T cells will be administered.\n\nParticipants who achieve partial response or complete response and subsequently experience disease progression will have an option to receive second course of conditioning chemotherapy therapy and axicabtagene ciloleucel. Participants will receive the same axicabtagene ciloleucel regimen as the original target dose anytime during the study.","label":"Axicabtagene Ciloleucel","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2023-10-12","type":"ACTUAL"},"conditions":["B-cell Lymphoma"],"enrollment":{"count":42,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Axicabtagene Ciloleucel","type":"BIOLOGICAL"},{"name":"Fludarabine","type":"DRUG"},{"name":"Cyclophosphamide","type":"DRUG"}],"last_update":"2024-12-04","lead_sponsor":"Kite, A Gilead Company","official_title":"A Phase 2 Multicenter Study Evaluating the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Subjects With High-Risk Large B-Cell Lymphoma (ZUMA-12)","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2023-10-12","type":"ACTUAL"},"primary_outcomes":[{"measure":"Complete Response (CR) Rate Per the Lugano Classification as Determined by Study Investigators","timeFrame":"Up to 4 years"}],"references":[{"citation":"Neelapu SS, Dickinson M, Munoz J, Ulrickson ML, Thieblemont C, Oluwole OO, et al. 739 Primary Analysis of ZUMA-12: A Phase 2 Study of Axicabtagene Ciloleucel (Axi-Cel) As First-Line Therapy in Patients with High-Risk Large B-Cell Lymphoma (LBCL) [Abstract]. 63rd American Society of Hematology (ASH) Annual Meeting and Exposition; 2021 11-14 December.","pmid":null,"type":"BACKGROUND"},{"citation":"Neelapu SS, Dickinson M, Ulrickson ML, Oluwole OO, Herrera AF, Thieblemont C, et al. 405 Interim Analysis of ZUMA-12: A Phase 2 Study of Axicabtagene Ciloleucel (Axi-Cel) as First-Line Therapy in Patients (Pts) With High-Risk Large B-Cell Lymphoma (LBCL) [Abstract]. 62nd American Society of Hematology (ASH) Annual Meeting and Exposition Virtual; 2020 05-08 December.","pmid":null,"type":"BACKGROUND"},{"citation":"Neelapu SS, Chavez JC, Lin Y, Munoz J, Ujjani CS, Riedell P, et al. ZUMA-12: A Phase 2 Multicenter Study of Axicabtagene Ciloleucel (Axi-Cel) as a First-Line Therapy in Patients (Pts) with High-Risk Large B-Cell Lymphoma (LBCL) [Abstract]. J Clin Oncol 2019;37 (15).","pmid":null,"type":"BACKGROUND"},{"citation":"Neelapu SS, Dickinson M, Munoz J, Ulrickson ML, Thieblemont C, Oluwole OO, Herrera AF, Ujjani CS, Lin Y, Riedell PA, Kekre N, de Vos S, Lui C, Milletti F, Dong J, Xu H, Chavez JC. Axicabtagene ciloleucel as first-line therapy in high-risk large B-cell lymphoma: the phase 2 ZUMA-12 trial. Nat Med. 2022 Apr;28(4):735-742. doi: 10.1038/s41591-022-01731-4. Epub 2022 Mar 21.","pmid":"35314842","type":"BACKGROUND"},{"citation":"Chavez JC, Dickinson M, Munoz JL, Ulrickson ML, Thieblemont C, Oluwole OO, et al. 3-Year Analysis of ZUMA-12: A Phase 2 Study of Axicabtagene Ciloleucel (Axi-Cel) As First-Line Therapy in Patients with High-Risk Large B-Cell Lymphoma (LBCL). Blood 2023;142 (Supplement 1):894-7","pmid":null,"type":"BACKGROUND"},{"citation":"Chavez JC, Dickinson M, Munoz J, Ulrickson ML, Thieblemont C, Oluwole OO, Herrera AF, Ujjani CS, Lin Y, Riedell PA, Kekre N, de Vos S, Wulff J, Williams CM, Winters J, Kloos I, Xu H, Neelapu SS. Three-year follow-up analysis of first-line axicabtagene ciloleucel for high-risk large B-cell lymphoma: the ZUMA-12 study. Blood. 2025 May 15;145(20):2303-2311. doi: 10.1182/blood.2024027347.","pmid":"39938019","type":"DERIVED"}],"start_date":{"date":"2019-01-29","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Participants With High-Risk Large B-Cell Lymphoma","url":"https://clinicaltrials.gov/study/NCT03761056"},"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-12-nct03761056"}