drugset / Trial / NCT04002401
Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in combination with rituximab, as measured by assessment of response rates in adult participants with relapsed/refractory large B-cell lymphoma.
Timeline
- Start
- 2019-11-05
- Primary completion
- 2023-01-30
- Completion
- 2023-01-30
Publications
- Strati P, Leslie L, Shiraz P, Budde LE, Oluwole OO, Ulrickson M, Ramakrishnan A, Zhang T, Sun J, Milletti F, Kanska J, Shen R, Neumann F, Xu H, Patel K. Axicabtagene ciloleucel in combination with rituximab for refractory large B cell lymphoma: the phase 2, single-arm ZUMA-14 trial. Nat Cancer. 2026 Feb;7(2):304-315. doi: 10.1038/s43018-025-01102-1. Epub 2026 Jan 5.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Axicabtagene Ciloleucel | Cell therapy | 2e+06 cells/kg | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 500 mg/m2 | — |
| Background | Fludarabine | Small molecule | 30 mg/m2 | — |