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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

NCT06854003 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-20

No results posted yet for this study

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)

Conditions

Interventions

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.

Sponsors & Collaborators

  • BeiGene

    collaborator INDUSTRY

  • Christine Ryan

    lead OTHER

Principal Investigators

  • Christine Ryan, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-22
Primary Completion
2029-11-01
Completion
2039-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06854003 on ClinicalTrials.gov