RecruitingPhase 2NCT06854003

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


Sponsor

Christine Ryan

Enrollment

60 participants

Start Date

Apr 22, 2025

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new treatment combination called BRAZAN — bendamustine, rituximab, cytarabine, and zanubrutinib (a targeted oral drug) — followed by maintenance therapy with or without another drug (sonrotoclax), for people newly diagnosed with mantle cell lymphoma, a type of blood cancer. **You may be eligible if:** - You are 18 years or older - You have been newly diagnosed with mantle cell lymphoma confirmed by biopsy - You have not had prior treatment for lymphoma (with very limited exceptions) - You have measurable disease on imaging - You have adequate blood counts and organ function - You are a candidate for high-dose cytarabine chemotherapy in your doctor's judgment **You may NOT be eligible if:** - The cancer has spread to your brain or spinal fluid - You have an active serious infection - You have had a major surgery within 4 weeks - You need warfarin for blood thinning (other blood thinners are okay) - You have a serious bleeding disorder - You had a stroke or brain bleed within 6 months - You have significant heart disease (e.g., recent heart attack, heart failure, uncontrolled arrhythmia) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBendamustine

An Alkylating agent, multi-dose vial, via intravenous (into the vein) infusion per institutional standard of care.

DRUGRituximab

An Anti-CD20 antibody, single-use vials, via intravenous infusion per institutional standard of care.

DRUGCytarabine

An Antineoplastic, single dose vial via intravenous infusion per institutional standard of care.

DRUGZanubrutinib

A BTK inhibitor, capsule taken orally per protocol.

DRUGSonrotoclax

A BCL 2 Protein Inhibitor, immediate release tablet, taken orally per protocol.


Locations(7)

Mayo Clinic Arizona

Phoenix, Arizona, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06854003


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