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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Christine Ryan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This Phase 2, multi-center, randomized study is 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 MCL. These specific maintenance therapy combinations are investigational and are being evaluated to see if the therapies may lengthen the time before MCL returns after initial therapy. After completing induction therapy, participants will be randomized into one of two groups: Arm A: zanubrutinib + rituximab or Arm B: zanubrutinib + rituximab + sonrotoclax. Randomization means a participant is placed into a study group by chance. The U.S. Food and Drug Administration (FDA) has approved bendamustine, cytarabine, rituximab, and zanubrutinib for the treatment of other lymphomas and/or blood cancers. The FDA has approved rituximab as a treatment option for Mantle Cell Lymphoma (MCL). The FDA has also approved zanubrutinib for mantle cell lymphoma, but only after trying other therapies first. The FDA has not approved sonrotoclax as a treatment for Mantle Cell Lymphoma (MCL). However sonrotoclax works similarly to a drug called venetoclax, which is also sometimes used to treat mantle cell lymphoma. The U.S. Food and Drug Administration (FDA) has approved venetoclax for the treatment of other blood cancers. The research study procedures include screening for eligibility, in-clinic treatment visits, electrocardiograms (ECGs), Positron Emission Tomography (PET) scans, Computerized Tomography CT) scans, blood tests, urine tests, lymph node biopsies, and bone marrow biopsies. It is expected that about 60 people will take part in this research study. The induction therapy will be 6 "cycles", or rounds of treatment, which will last for up to a little over 5 months. The maintenance therapy will last for up to 2 years. * Induction phase: * Bendamustine/Rituximab + Zanubrutinib for 3 cycles * Rituximab/Cytarabine for 3 cycles * Maintenance phase - either: * A) Zanubrutinib + Rituximab, or * B) Zanubrutinib + Sonrotoclax + Rituximab BeiGene, Ltd., a pharmaceutical company, is also supporting this research study by providing the drugs zanubrutinib and sonrotoclax and other funding support.

Conditions

• Mantle Cell Lymphoma
• Lymphoma

Interventions

Type	Name	Description
DRUG	Bendamustine	An Alkylating agent, multi-dose vial, via intravenous (into the vein) infusion per institutional standard of care.
DRUG	Rituximab	An Anti-CD20 antibody, single-use vials, via intravenous infusion per institutional standard of care.
DRUG	Cytarabine	An Antineoplastic, single dose vial via intravenous infusion per institutional standard of care.
DRUG	Zanubrutinib	A BTK inhibitor, capsule taken orally per protocol.
DRUG	Sonrotoclax	A BCL 2 Protein Inhibitor, immediate release tablet, taken orally per protocol.

Timeline

• Start date: 2025-04-22
• Primary completion: 2029-11-01
• Completion: 2039-11-01
• First posted: 2025-03-03
• Last updated: 2026-02-20

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study