drugset / Trial / NCT06854003
BRAZAN: A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Followed by Zanubrutinib/Rituximab +/- Sonrotoclax Maintenance in Treatment-Naïve Mantle Cell Lymphoma
RandomizedSequentialOpen-labelTreatment
Summary
This study aims to evaluate the efficacy and safety of an induction regimen combining Bendamustine, Rituximab, Cytarabine (AraC), and Zanubrutinib (BRAZAN), followed by maintenance therapy with Zanubrutinib and Rituximab with or without Sonrotoclax in participants with Mantle Cell Lymphoma (MCL). The names of the study drugs involved in this study are: * bendamustine (a type of alkylating agent) * rituximab (a type of monoclonal antibody) * cytarabine (a type of antineoplastic) * zanubrutinib (a type of kinase inhibitor) * sonrotoclax (a type of BCL2 inhibitor)
Timeline
- Start
- 2025-04-22
- Primary completion
- 2029-11-01
- Completion
- 2039-11-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bendamustine | Small molecule | — | Intravenous |
| Subject | Cytarabine | Small molecule | — | Intravenous |
| Subject | Rituximab | Monoclonal antibody | — | Intravenous |
| Subject | Sonrotoclax | Other / unclassified | — | Oral |
| Subject | Zanubrutinib | Small molecule | — | Oral |