{"commentary":{"count":109,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":45,"podcast":38,"x_thread":26},"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\": \"NCT02348216\", \"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-1","nct_id":"NCT02348216","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=zuma-1-nct02348216. 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-1","arms":[{"description":"Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) will receive conditioning chemotherapy (fludarabine 30 mg/m\\^2 intravenously \\[IV\\] over 30 minutes and cyclophosphamide 500 mg/m\\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel chimeric antigen receptor (CAR) transduced autologous T cells administered IV at a target dose of 2 x 10\\^6 anti-CD19 CAR T cells/kg of body weight (BW) on Day 0.","label":"Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy","type":"EXPERIMENTAL"},{"description":"Participants with refractory DLBCL will receive conditioning chemotherapy (fludarabine 30 mg/m\\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\\^6 anti-CD19 CAR T cells/kg of BW on Day 0.","label":"Phase 2 (Pivotal Study): Cohort 1","type":"EXPERIMENTAL"},{"description":"Participants with refractory PMBCL or TFL will receive conditioning chemotherapy (fludarabine 30 mg/m\\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\\^6 anti-CD19 CAR T cells/kg of BW on Day 0.","label":"Phase 2 (Pivotal Study): Cohort 2","type":"EXPERIMENTAL"},{"description":"Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL will receive conditioning chemotherapy (fludarabine 30 mg/m\\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants will also receive a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).","label":"Phase 2 (Safety Management Study): Cohort 3","type":"EXPERIMENTAL"},{"description":"Participants with r/r DLBCL,PMBCL,TFL,or high-grade B-cell lymphoma(HGBCL)after 2 systemic lines of therapy will receive optional bridging therapy(dexamethasone 20mg to 40mg,eitherorally or IV daily for 1 to 4 days or 1g/m\\^2 of high-dose methylprednisolone(HDMP)for 3 days with rituximab at 375mg/m\\^2 weekly for 3 weeks or bendamustine 90 mg/m\\^2 on Days 1 and 2 and rituximab 375mg/m\\^2 on Day 1),conditioning chemotherapy(fludarabine 30mg/m\\^2 IV and cyclophosphamide 500mg/m\\^2 IV)on Days -5,-4, and -3;followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\\^6 anti-CD19 CAR T cells/kg of BW. Participants will receive a prophylactic regimen of levetiracetam(750 mg orally or IV twice daily(BID)starting on Day 0).Participants will receive tocilizumab(initiated on persistent Grade 1 cytokine release syndrome(CRS)for over 24 hours)and dexamethasone(persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).","label":"Phase 2 (Safety Management Study): Cohort 4","type":"EXPERIMENTAL"},{"description":"Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy will receive debulking therapy (R-CHOP:rituximab 375mg/m\\^2 D1,doxorubicin 50mg/m\\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\\^2 D1,vincristine 1.4 mg/m\\^2 D1 or R-ICE:rituximab 375mg/ m\\^2 D1,ifosfamide 5g/m\\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\\^2 D1,gemcitabine 1000mg/m\\^2 D2,oxaliplatin 100mg/m\\^2 D2 or R-GDP:rituximab 375mg/m\\^2 D1 or D8,gemcitabine 1g/m\\^2 D1 \\& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\\^2 IV and cyclophosphamide 500mg/m\\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants will also receive a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.","label":"Phase 2 (Safety Management Study): Cohort 5","type":"EXPERIMENTAL"},{"description":"Participants with r/r DLBCL,PMBCL,TFL orHGBCL after 2 systemic lines of therapy may receive bridging therapy(dexamethasone 20mg to 40mg,orally or IV daily for 1 to 4 days or 1g/m\\^2 HDMP for 3 days with rituximab at 375mg/m\\^2 weekly for 3 weeks or bendamustine 90 mg/m\\^2 on Days 1 and 2 and rituximab 375mg/m\\^2 on Day 1),conditioning chemotherapy(fludarabine 30mg/m\\^2 IV and cyclophosphamide 500mg/m\\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\\^6 anti-CD19 CAR T cells/kg of BW on Day 0.Participants will also receive a prophylactic regimen of levetiracetam 750 mg orally or IV twice daily(BID)starting on Day 0)and corticosteroids(dexamethasone, 10 mg once daily on Days 0, 1, and 2).Participants will receive tocilizumab(initiated on persistent Grade 1 CRS for over 24 hours)and dexamethasone(persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).","label":"Phase 2 (Safety Management Study): Cohort 6","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2023-07-27","type":"ACTUAL"},"conditions":["Refractory Diffuse Large B Cell Lymphoma (DLBCL)","Relapsed Diffuse Large B-Cell Lymphoma","Transformed Follicular Lymphoma (TFL)","Primary Mediastinal B-cell Lymphoma (PMBCL)","High Grade B-cell Lymphoma (HGBCL)"],"enrollment":{"count":307,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Axicabtagene Ciloleucel","type":"BIOLOGICAL"},{"name":"Fludarabine","type":"DRUG"},{"name":"Cyclophosphamide","type":"DRUG"},{"name":"Levetiracetam","type":"DRUG"},{"name":"Tocilizumab","type":"DRUG"},{"name":"Dexamethasone","type":"DRUG"},{"name":"High-dose methylprednisolone","type":"DRUG"},{"name":"Bendamustine","type":"DRUG"},{"name":"Rituximab","type":"DRUG"},{"name":"Doxorubicin","type":"DRUG"},{"name":"Prednisone","type":"DRUG"},{"name":"Vincristine","type":"DRUG"},{"name":"Ifosfamide","type":"DRUG"},{"name":"Carboplatin","type":"DRUG"},{"name":"Etoposide","type":"DRUG"},{"name":"Gemcitabine","type":"DRUG"},{"name":"Oxaliplatin","type":"DRUG"},{"name":"Cisplatin","type":"DRUG"},{"name":"Methylprednisolone","type":"DRUG"}],"last_update":"2024-06-04","lead_sponsor":"Kite, A Gilead Company","official_title":"A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-C19 in Adults With Refractory Aggressive Non-Hodgkin Lymphoma","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2023-07-27","type":"ACTUAL"},"primary_outcomes":[{"measure":"Phase 1 Study: Number of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs)","timeFrame":"First infusion date of axicabtagene ciloleucel up to 30 days"},{"measure":"Phase 2 Pivotal Study (Cohorts 1 and 2): Overall Response Rate (ORR) as Assessed by Investigator Per Revised International Working Group (IWG) Response Criteria for Malignant Lymphoma","timeFrame":"First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 7.7 years)"},{"measure":"Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades","timeFrame":"First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 6.8 years)"},{"measure":"Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades","timeFrame":"First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 5.4 years)"},{"measure":"Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades","timeFrame":"First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 4.4 years)"},{"measure":"Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades","timeFrame":"First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 4.1 years)"}],"references":[{"citation":"Topp MS, van Meerten T, Wermke M et al. Preliminary Results of Earlier Steroid Use with Axicabtagene Ciloleucel in Patients With Relapsed/Refractory Large B Cell Lymphoma. Poster presented at the American Society of Presented at: American Society of Clinical Oncology Annual Meeting. May 31-June 4, 2019; Chicago, Illinois; Abstract 7558.","pmid":null,"type":"RESULT"},{"citation":"Topp, M, van Meerten T, Houot R, et al. (2019). Earlier Steroid Use with Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory Large B Cell Lymphoma. Blood (ASH Annual Meeting Abstracts) 134(Suppl 1): 243. Abstract 626.","pmid":null,"type":"RESULT"},{"citation":"Abstract: Oluwole OO, et al. Prophylactic corticosteroid use with axicabtagene ciloleucel in patients with relapsed/refractory large B-cell lymphoma. Transplantation and Cellular Therapy 2021.","pmid":null,"type":"RESULT"},{"citation":"Oluwole OO, Bouabdallah K, Munoz J, De Guibert S, Vose JM, Bartlett NL, Lin Y, Deol A, McSweeney PA, Goy AH, Kersten MJ, Jacobson CA, Farooq U, Minnema MC, Thieblemont C, Timmerman JM, Stiff P, Avivi I, Tzachanis D, Kim JJ, Bashir Z, McLeroy J, Zheng Y, Rossi JM, Johnson L, Goyal L, van Meerten T. Prophylactic corticosteroid use in patients receiving axicabtagene ciloleucel for large B-cell lymphoma. Br J Haematol. 2021 Aug;194(4):690-700. doi: 10.1111/bjh.17527. Epub 2021 Jul 22.","pmid":"34296427","type":"RESULT"},{"citation":"Santa Monica, Calif. New Four-Year Data Show Long-Term Survival in Patients With Large B-Cell Lymphoma Treated With Yescarta® in ZUMA-1 Trial. Data presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition. December 5, 2020; Abstract 1187","pmid":null,"type":"RESULT"},{"citation":"Max S. Topp, Tom van Meerten, Martin Wermke, Pieternella J. Lugtenburg, Monique C. Minnema, Kevin W. Song, Catherine Thieblemont, Yizhou Jiang, Vicki Plaks, Anne Kerber, Marie José Kersten. Preliminary Results of Earlier Steroid Use With Axicabtagene Ciloleucel in Patients With Relapsed/ Refractory Large B Cell Lymphoma. Poster presented at ASCO 2019 Annual Meeting. June 3, 2019; Abstract 7558","pmid":null,"type":"RESULT"},{"citation":"Sattva S. Neelapu, Caron A. Jacobson, Olalekan O. Oluwole, Javier Munoz, Abhinav Deol, David B. Miklos, Nancy L. Bartlett, Ira Braunschweig, Yizhou Jiang, Jenny J. Kim, Lianqing Zheng, John M. Rossi, Frederick L. Locke. Axicabtagene Ciloleucel (Axi-Cel) In Refractory Large B Cell Lymphoma: Outcomes in Patients ≥ or < 65 Years of Age in the Pivotal Phase 1/2 ZUMA-1 Study. Poster presented at EHA 2019. June 15, 2019; Abstract 1066","pmid":null,"type":"RESULT"},{"citation":"Max S. Topp, Tom van Meerten, Martin Wermke, Pieternella J. Lugtenburg, Monique C. Minnema, Kevin W. Song, Catherine Thieblemont, Yizhou Jiang, Vicki Plaks, Anne Kerber, Marie José Kersten. Axicabtagene Ciloleucel (Axi-Cel) in Patients With Relapsed/Refractory Large B Cell Lymphoma: Preliminary Results of Earlier Steroid Use. Poster presented at EHA 2019. June 15, 2019; Abstract 1067","pmid":null,"type":"RESULT"},{"citation":"Sattva S. Neelapu, John M. Rossi, Caron A. Jacobson, Frederick L. Locke, David B. Miklos, Patrick M. Reagan, Scott Rodig, Lazaros J. Lekakis, Ian W. Flinn, Lianqing Zheng, Francesca Milletti, Edmund Chang, Allen Xue, Vicki Plaks, Jenny J. Kim, Adrian Bot. CD19-Loss With Preservation of Other B Cell Lineage Features in Patients With Large B Cell Lymphoma Who Relapsed Post-Axi-Cel. Blood (ASH Annual Meeting Abstracts) 134(Suppl 1): 203. Abstract 704.","pmid":null,"type":"RESULT"},{"citation":"Sattva S. Neelapu, Frederick L. Locke, Nancy L. Bartlett, Lazaros J. Lekakis, Patrick Reagan, David B. Miklos, Caron A. 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Five-year follow-up of ZUMA-1 supports the curative potential of axicabtagene ciloleucel in refractory large B-cell lymphoma. Blood. 2023 May 11;141(19):2307-2315. doi: 10.1182/blood.2022018893.","pmid":"36821768","type":"DERIVED"},{"citation":"Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.","pmid":"34515338","type":"DERIVED"},{"citation":"Maloney DG, Kuruvilla J, Liu FF, Kostic A, Kim Y, Bonner A, Zhang Y, Fox CP, Cartron G. Matching-adjusted indirect treatment comparison of liso-cel versus axi-cel in relapsed or refractory large B cell lymphoma. 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Epub 2020 Dec 17.","pmid":"33334730","type":"DERIVED"},{"citation":"Locke FL, Rossi JM, Neelapu SS, Jacobson CA, Miklos DB, Ghobadi A, Oluwole OO, Reagan PM, Lekakis LJ, Lin Y, Sherman M, Better M, Go WY, Wiezorek JS, Xue A, Bot A. Tumor burden, inflammation, and product attributes determine outcomes of axicabtagene ciloleucel in large B-cell lymphoma. Blood Adv. 2020 Oct 13;4(19):4898-4911. doi: 10.1182/bloodadvances.2020002394.","pmid":"33035333","type":"DERIVED"},{"citation":"Locke FL, Ghobadi A, Jacobson CA, Miklos DB, Lekakis LJ, Oluwole OO, Lin Y, Braunschweig I, Hill BT, Timmerman JM, Deol A, Reagan PM, Stiff P, Flinn IW, Farooq U, Goy A, McSweeney PA, Munoz J, Siddiqi T, Chavez JC, Herrera AF, Bartlett NL, Wiezorek JS, Navale L, Xue A, Jiang Y, Bot A, Rossi JM, Kim JJ, Go WY, Neelapu SS. Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial. Lancet Oncol. 2019 Jan;20(1):31-42. doi: 10.1016/S1470-2045(18)30864-7. Epub 2018 Dec 2.","pmid":"30518502","type":"DERIVED"},{"citation":"Neelapu SS, Locke FL, Bartlett NL, Lekakis LJ, Miklos DB, Jacobson CA, Braunschweig I, Oluwole OO, Siddiqi T, Lin Y, Timmerman JM, Stiff PJ, Friedberg JW, Flinn IW, Goy A, Hill BT, Smith MR, Deol A, Farooq U, McSweeney P, Munoz J, Avivi I, Castro JE, Westin JR, Chavez JC, Ghobadi A, Komanduri KV, Levy R, Jacobsen ED, Witzig TE, Reagan P, Bot A, Rossi J, Navale L, Jiang Y, Aycock J, Elias M, Chang D, Wiezorek J, Go WY. Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma. N Engl J Med. 2017 Dec 28;377(26):2531-2544. doi: 10.1056/NEJMoa1707447. Epub 2017 Dec 10.","pmid":"29226797","type":"DERIVED"}],"start_date":{"date":"2015-04-21","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma","url":"https://clinicaltrials.gov/study/NCT02348216"},"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-1-nct02348216"}