A Study of Axicabtagene Ciloleucel in Participants With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma

Summary

The goal of this study is to assess whether axicabtagene ciloleucel improves the clinical outcome in participants with relapsed or refractory indolent non-Hodgkin lymphoma (r/r) iNHL.

Timeline

Start

2017-06-06

Primary completion

2024-12-20

Completion

2024-12-20

Publications

• Background Jacobson CA, Chavez JC, Sehgal AR, et al. Interim analysis of ZUMA-5: A phase II study of axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory indolent non-Hodgkin lymphoma (R/R iNHL). Conference Proceedings of the American Society of Clinical Oncology 2020
• Background Jacobson CA, Chavez JC, Sehgal AR, et al. Interim analysis of ZUMA-5: A phase II study of axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory indolent non-Hodgkin lymphoma (R/R iNHL) [Abstract]. Conference Proceedings of the Society of Hematologic Oncology 2020.
• Background Jacobson CA, Chavez JC, Sehgal AR, et al. Interim analysis of ZUMA-5: A phase II study of axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory indolent non-Hodgkin lymphoma (R/R iNHL) [Abstract]. Clinical Lymphoma, Myeloma and Leukemia 2020;20 (1 Suppl):S278.
• Background Jacobson C, Chavez JC, Sehgal AR, et al. Primary analysis of Zuma-5: A phase 2 study of axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory (r/r) indolent non-Hodgkin lymphoma (iNHL). Blood 2020;136 (1 Suppl):40-41.
• Background Chavez JC, Jacobson CA, Sehgal AR, et al. Retreatment with axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory indolent non-Hodgkin lymphoma in ZUMA-5. Blood 2020;136 (1 Suppl):34.
• Background Jacobson CA, Chavez JC, Sehgal AR, William BM, Munoz J, Salles G, Munshi PN, Casulo C, Maloney DG, de Vos S, Reshef R, Leslie LA, Yakoub-Agha I, Oluwole OO, Fung HCH, Rosenblatt J, Rossi JM, Goyal L, Plaks V, Yang Y, Vezan R, Avanzi MP, Neelapu SS. Axicabtagene ciloleucel in relapsed or refractory indolent non-Hodgkin lymphoma (ZUMA-5): a single-arm, multicentre, phase 2 trial. Lancet Oncol. 2022 Jan;23(1):91-103. doi: 10.1016/S1470-2045(21)00591-X. Epub 2021 Dec 8.
• Background Chavez JC, Jacobson CA, Sehgal A, et al. Updated outcomes with axicabtagene ciloleucel (axi-cel) retreatment (reTx) in patients (pts) with relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5. J Clin Oncol 2021;39 (15 suppl):7548.
• Background Chavez JC, Jacobson CA, Sehgal AR, et al. Retreatment with axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory (r/r) indolent non-hodgkin lymphoma (iNHL) in ZUMA-5 [Oral abstract]. Transplantation and Cellular Therapy 2021;27 (Issue 3, Supplement):S43, ISSN 2666-6367
• Background Chavez JC, Jacobson CA, Sehgal AR, et al. Retreatment with axicabtagene ciloleucel in patients with relapsed/refractory indolent non-hodgkin lymphoma in ZUMA-5 [Oral abstract]. British Journal of Heamatology 2021;193. Abstract BSH2021-PO-149.
• Background Chavez JC, Jacobson CA, Sehgal AR, et al. Updated outcomes with axicabtagene ciloleucel (axi-cel) retreatment in patients with relapsed/refractory indolent non-Hodgkin lymphoma in ZUMA-5 [Abstract]. European Hematology Association (EHA) 2021:325549.
• Background Ghione P, Patel A, Bobillo S, et al. A comparison of clinical outcomes from Zuma-5 (axicabtagene ciloleucel) and the international scholar-5 external control cohort in relapsed/refractory follicular lymphoma (R/R/FL) [Abstract]. European Hematology Association (EHA) Virtual; 2021 09-17 June.
• Background Ghione P, Palomba ML, Ghesquieres H, Bobillo S, Patel AR, Nahas M, Kanters S, Deighton K, Hatswell A, Ma L, Limbrick-Oldfield EH, Snider JT, Wade SW, Riberio MT, Radford J, Beygi S, Gribben J. Treatment patterns and outcomes in relapsed/refractory follicular lymphoma: results from the international SCHOLAR-5 study. Haematologica. 2023 Mar 1;108(3):822-832. doi: 10.3324/haematol.2022.281421.
• Background Jacobson CA, Chavez JC, Sehgal A, et al. Outcomes in ZUMA-5 with axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) who had the high-risk feature of progression within 24 months from initiation of first anti-CD20-containing chemoimmunotherapy (POD24). J Clin Oncol 2021a;39 (15 Suppl):7515
• Background Jacobson CA, Chavez JC, Sehgal AR, et al. Outcomes in Zuma-5 with axicabtagene ciloleucel in patients with relapsed/refractory indolent non-Hodgkin lymphoma who had the high-risk feature of early progression after first chemoimmunotherapy [Abstract]. European Hematology Association (EHA) Virtual; 2021b 09-17 June.
• Background Jacobson CA, Chavez JC, Sehgal AR, et al. Primary analysis of ZUMA-5: A phase 2 study of axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory (r/r) indolent non-Hodgkin lymphoma (iNHL) [Oral abstract 69]. Transplantation and Cellular Therapy 2021; 27 (Issue 3, Supplement): S67-S68, ISSN 2666-6367
• Background Jacobson CA, Chavez JC, Sehgal AR, et al. Primary analysis of ZUMA-5: A phase 2 study of axicabtagene ciloleucel in patients with relapsed/refractory indolent non-hodgkin lymphoma [Oral abstract]. British Journal of Heamatology 2021, BSH2021-OR-036.
• Background Neelapu SS, Chavez JC, Sehgal AR, et al. Long-term follow-up analysis of ZUMA-5: A phase 2 study of axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) [Abstract 93]. Blood 2021;138 (1 Suppl)
• Background Plaks V, Chou J, Goyal L, et al. Axicabtagene ciloleucel (axi-cel) product attributes and immune biomarkers associated with clinical outcomes in patients (pts) with relapsed/refractory R/R) indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5 [Abstract CT036]. Cancer Res 2021;81 (13 Suppl).
• Background Kanters S, Ball G, Kahl B, Wiesinger A, Limbrick-Oldfield EH, Sudhindra A, Snider JT, Patel AR. Clinical outcomes in patients relapsed/refractory after >/=2 prior lines of therapy for follicular lymphoma: a systematic literature review and meta-analysis. BMC Cancer. 2023 Jan 23;23(1):74. doi: 10.1186/s12885-023-10546-6.
• Background Palomba ML, Ghione P, Patel AR, et al. A comparison of clinical outcomes from updated ZUMA-5 (axicabtagene ciloleucel) and the international scholar-5 external control cohort in relapsed/refractory follicular lymphoma (R/R FL) [Abstract PB1571]. Blood 2021;138 (1 Suppl):3543.
• Background Neelapu SS, Chavez JC, Sehgal AR, et al. Long-term follow-up analysis of Zuma-5: A phase 2 study of axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory (r/r) indolent non-Hodgkin lymphoma (iNHL) [Abstract 75]. Transplantation and Cellular Therapy 2022;28 (Issue 3, Supplement):S64-S65, ISSN 2666-6367.
• Background Neelapu SS, Chavez JC, Sehgal AR, et al. Long-term analysis of ZUMA-5 phase 2 study of axicabtagene ciloleucel in patients with indolent non-Hodgkin lymphoma [Oral presentation O3-5]. 2022 Japanese Society of Medical Oncology - 19th Scientific Meeting
• Background Hatswell AJ, Deighton K, Snider JT, Brookhart MA, Faghmous I, Patel AR. Approaches to Selecting "Time Zero" in External Control Arms with Multiple Potential Entry Points: A Simulation Study of 8 Approaches. Med Decis Making. 2022 Oct;42(7):893-905. doi: 10.1177/0272989X221096070. Epub 2022 May 6.
• Background Ghione P, Palomba ML, Patel AR, Bobillo S, Deighton K, Jacobson CA, Nahas M, Hatswell AJ, Jung AS, Kanters S, Snider JT, Neelapu SS, Ribeiro MT, Brookhart MA, Ghesquieres H, Radford J, Gribben JG. Comparative effectiveness of ZUMA-5 (axi-cel) vs SCHOLAR-5 external control in relapsed/refractory follicular lymphoma. Blood. 2022 Aug 25;140(8):851-860. doi: 10.1182/blood.2021014375.
• Background Neelapu SS, Chavez JC, Sehgal AR, et al. 3-Year follow-up analysis of ZUMA-5: A phase 2 study of axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory (r/r) indolent non-Hodgkin lymphoma (iNHL). Blood 2022;140 (1 Suppl):10380-10383.
• Background Oluwole OO, Ray MD, Rosettie KL, Ball G, Jacob J, Bilir SP, Patel AR, Jacobson CA. Cost-Effectiveness of Axicabtagene Ciloleucel for Adult Patients With Relapsed or Refractory Follicular Lymphoma in the United States. Value Health. 2024 Aug;27(8):1030-1038. doi: 10.1016/j.jval.2024.04.003. Epub 2024 Apr 17.
• Background Ghione P, Palomba ML, Ray MD, et al. A 3-year follow-up comparison of clinical outcomes from Zuma-5 (axicabtagene ciloleucel) and the international Scholar-5 external control cohort in relapsed/refractory follicular lymphoma (R/R FL). Blood 2022;140 (1 Suppl):4676-4677.
• Background Neelapu SS, Chavez JC, Sehgal AR, et al. 3-Year follow-up analysis of Zuma-5: A phase 2 study of axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory (r/r) indolent non-Hodgkin lymphoma (iNHL) [Abstract 500]. Transplantation and Cellular Therapy 2023;29 (Issue 2, Supplement):S374, ISSN 2666-6367
• Background Palomba ML, Ghione P, Patel AR, Nahas M, Beygi S, Hatswell AJ, Kanters S, Limbrick-Oldfield EH, Wade SW, Ray MD, Owen J, Neelapu SS, Gribben J, Radford J, Bobillo S. A 24-month updated analysis of the comparative effectiveness of ZUMA-5 (axi-cel) vs. SCHOLAR-5 external control in relapsed/refractory follicular lymphoma. Expert Rev Anticancer Ther. 2023 Feb;23(2):199-206. doi: 10.1080/14737140.2023.2171994. Epub 2023 Feb 10.
• Background Patel AR, Limbrick-Oldfield EH, Kanters S, et al., The prognostic value of progressing within 24 months of frontline chemoimmunotherapy (POD24) in relapsed/refractory (R/R) follicular lymphoma (FL)-a SCHOLAR-5 analysis. Hematological Oncology 2023;41:376-377.
• Background Ray MD, Kanters S, Beygi S, et al. Matching-adjusted indirect comparison of axicabtagene ciloleucel versus mosunetuzumab in relapsed/refractory follicular lymphoma patients after 2 prior systemic treatments. Hematological Oncology 2023;41:522-523
• Background Neelapu SS, Chavez JC, Sehgal AR, et al. Axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory indolent non-Hodgkin lymphoma: 4-year follow-up from the phase 2 ZUMA-5 trial. Blood 2023;142 (1 Suppl):4868.
• Background Bachy E, Neelapu SS, Chavez JC, et al. A retrospective intra-patient analysis from ZUMA-5: Axicabtagene ciloleucel (axi-cel) compared with prior standard-of-care therapy in patients with relapsed/refractory follicular lymphoma. Blood 2023;142 (1 Suppl):4865.
• Background Gribben JG, Ghione P, Palomba ML, et al. An updated comparison of clinical outcomes from 4-year follow-up of Zuma-5 (axicabtagene ciloleucel) and the international Scholar-5 external control cohort in relapsed/refractory follicular lymphoma. Blood 2023;142 (1 Suppl):4869.
• Background Eklund O, Hedlöf Kanje V, Doble B, et al. EE536 Cost-effectiveness of axicabtagene ciloleucel (axi-cel) vs standard of care for adult patients with relapsed or refractory follicular lymphoma as 4TH or later line treatment in Sweden. Value in Health 2023;26 (Issue 12, Supplement):S155, ISSN 1098-3015.
• Background Ghione P, Palomba ML, Ray MD, Limbrick-Oldfield EH, Owen J, Kanters S, Bobillo S, Ribiero MT, Jacobson CA, Neelapu SS, Ghesquieres H, Nahas M, Beygi S, Patel AR, Gribben JG. A Comparison of 3-Year Follow-up of ZUMA-5 (Axicabtagene Ciloleucel) With SCHOLAR-5 in Relapsed/Refractory Follicular Lymphoma. Clin Lymphoma Myeloma Leuk. 2024 May;24(5):e191-e195.e6. doi: 10.1016/j.clml.2024.01.011. Epub 2024 Jan 24.
• Background Neelapu SS, Chavez JC, Sehgal AR, Epperla N, Ulrickson M, Bachy E, Munshi PN, Casulo C, Maloney DG, de Vos S, Reshef R, Leslie LA, Oluwole OO, Yakoub-Agha I, Khanal R, Rosenblatt J, Korn R, Peng W, Lui C, Wulff J, Shen R, Poddar S, Jung AS, Miao H, Beygi S, Jacobson CA. Three-year follow-up analysis of axicabtagene ciloleucel in relapsed/refractory indolent non-Hodgkin lymphoma (ZUMA-5). Blood. 2024 Feb 8;143(6):496-506. doi: 10.1182/blood.2023021243.
• Background Oluwole OO, Ray MD, Zur RM, Ferrufino CP, Doble B, Patel AR, Bilir SP. Cost-effectiveness of treating relapsed or refractory 3L+ follicular lymphoma with axicabtagene ciloleucel vs mosunetuzumab in the United States. Front Immunol. 2024 May 24;15:1393939. doi: 10.3389/fimmu.2024.1393939. eCollection 2024.
• Background Ray MD, Kanters S, Beygi S, Best T, Wulff J, Limbrick-Oldfield E, Patel AR, Oluwole OO. Matching-Adjusted Indirect Comparisons of Axicabtagene Ciloleucel to Mosunetuzumab for the Treatment of Relapsed/Refractory Follicular Lymphoma. Transplant Cell Ther. 2024 Sep;30(9):885.e1-885.e11. doi: 10.1016/j.jtct.2024.06.016. Epub 2024 Jun 19.
• Background Neelapu SS, Chavez JC, Sehgal AR, et al. 5-year follow-up analysis from ZUMA-5: A phase 2 trial of axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory indolent non-Hodgkin lymphoma. Blood 2024;144 (1 Suppl):864.
• Background Poddar S, Yan J, Tiwari G, et al. Impact of inflammation, tumor and product attributes on clinical outcomes in patients with relapsed/refractory follicular lymphoma treated with axicabtagene ciloleucel. Blood 2024;144 (1 Suppl):4368
• Background Limbrick-Oldfield EH, Kanters S, Ray MD, Best T, Palivela M, Beygi S, Patel AR, Gribben JG, Ghione P. The prognostic value of POD24 in relapsed/refractory follicular lymphoma-A SCHOLAR-5 analysis. EJHaem. 2025 Feb 6;6(1):e1104. doi: 10.1002/jha2.1104. eCollection 2025 Feb.
• Neelapu SS, Chavez JC, Sehgal AR, Epperla N, Ulrickson ML, Bachy E, Munshi PN, Casulo C, Maloney DG, de Vos S, Reshef R, Leslie LA, Oluwole OO, Yakoub-Agha I, Khanal R, Rosenblatt JD, Wulff J, Shen RR, Zhang W, Poddar S, Miao H, Nikolajeva O, Jacobson CA. Five-Year Follow-Up Analysis of ZUMA-5: Axicabtagene Ciloleucel in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma. J Clin Oncol. 2025 Nov 20;43(33):3573-3577. doi: 10.1200/JCO-25-00668. Epub 2025 Oct 16.
• Poddar S, Yan J, Tiwari G, Rinchai D, Budka J, Zhang W, Peng W, Salunkhe S, Davis M, Song Q, Beygi S, Miao H, Mattie M, Shen RS, Jacobson CA, Bedognetti D, Filosto S, Neelapu SS. Clinical, tumor, and product features associated with outcomes after axicabtagene ciloleucel therapy in follicular lymphoma. J Clin Invest. 2025 Aug 15;135(16):e181893. doi: 10.1172/JCI181893. eCollection 2025 Aug 15.
• Chartier M, Filosto S, Peyret T, Chiney M, Milletti F, Budka J, Ndi A, Dong J, Vardhanabhuti S, Mao D, Duffull S, Dodds M, Shen R. Investigating the Influence of Covariates on Axicabtagene Ciloleucel (axi-cel) Kinetics in Patients with Non-Hodgkin's Lymphoma. Clin Pharmacokinet. 2024 Sep;63(9):1283-1299. doi: 10.1007/s40262-024-01413-z. Epub 2024 Sep 6.

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