drugset / Trial / NCT03570892
Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma
RandomizedParallel-groupSingle-blindTreatment
Summary
This is a randomized, open label, multicenter phase III trial comparing the efficacy, safety, and tolerability of tisagenlecleucel to Standard Of Care in adult patients with aggressive B-cell Non-Hodgkin Lymphoma after failure of rituximab and anthracycline containing frontline immunochemotherapy.
Timeline
- Start
- 2019-05-09
- Primary completion
- 2021-05-06
- Completion
- 2026-02-03
Outcome
Missed primary endpoint
paper The median event-free survival in both groups was 3.0 months PMID 34904798 ↗
paper Tisagenlecleucel was not superior to standard salvage therapy in this trial. PMID 34904798 ↗
release “Phase III BELINDA study did not meet primary endpoint of event-free survival for patients with aggressive B-cell non-Hodgkin lymphoma” novartis.com ↗
Publications
- Bishop MR, Dickinson M, Purtill D, Barba P, Santoro A, Hamad N, Kato K, Sureda A, Greil R, Thieblemont C, Morschhauser F, Janz M, Flinn I, Rabitsch W, Kwong YL, Kersten MJ, Minnema MC, Holte H, Chan EHL, Martinez-Lopez J, Muller AMS, Maziarz RT, McGuirk JP, Bachy E, Le Gouill S, Dreyling M, Harigae H, Bond D, Andreadis C, McSweeney P, Kharfan-Dabaja M, Newsome S, Degtyarev E, Awasthi R, Del Corral C, Andreola G, Masood A, Schuster SJ, Jager U, Borchmann P, Westin JR. Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma. N Engl J Med. 2022 Feb 17;386(7):629-639. doi: 10.1056/NEJMoa2116596. Epub 2021 Dec 14.
- 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.
- Thiruvengadam SK, Hunter B, Varnavski A, Fakhri B, Kaplan L, Ai WZ, Pampaloni M, Huang CY, Martin T 3rd, Damon L, Andreadis CB. Ofatumumab, Etoposide, and Cytarabine Intensive Mobilization Regimen in Patients with High-risk Relapsed/Refractory Diffuse Large B-Cell Lymphoma Undergoing Autologous Stem Cell Transplantation. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):246-256.e2. doi: 10.1016/j.clml.2020.11.005. Epub 2020 Nov 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tisagenlecleucel | Cell therapy | — | — |
| Background | Bendamustine | Small molecule | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |
| Comparator | Ibrutinib | Small molecule | — | — |
| Comparator | Lenalidomide | Other / unclassified | — | — |