Actively Recruiting
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
Led by Christine Ryan · Updated on 2026-02-20
60
Participants Needed
7
Research Sites
758 weeks
Total Duration
On this page
Sponsors
C
Christine Ryan
Lead Sponsor
B
BeiGene
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed mantle cell lymphoma diagnosis confirmed by participating institutions
- No previous anti-lymphoma therapy except prior radiotherapy for localized or urgent symptomatic disease
- At least one measurable disease lesion on PET, CT, or MRI that is FDG-avid
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Age 18 years or older and suitable for high-dose cytarabine as judged by the treating physician
- Adequate blood counts and organ function meeting specified laboratory thresholds
- Controlled HIV infection if present, with stable anti-retroviral therapy and no drug interactions
- Willingness to provide a pre-treatment tumor sample by biopsy or archival tissue within 90 days
- Willingness to use effective contraception or remain abstinent from screening until specified time after treatment
- Ability to understand and sign informed consent
You will not qualify if you...
- Known central nervous system involvement
- Active infection requiring systemic antimicrobial treatment at enrollment
- Major surgery or significant injury within 4 weeks before starting study drug
- Need for warfarin or vitamin K antagonist anticoagulation (other anticoagulants allowed)
- History of severe bleeding disorders or recent stroke or significant bleeding events
- Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia unless related to lymphoma
- Active hepatitis B or C infection without proper control or monitoring
- Prior malignancy unless treated with curative intent and disease-free for at least 3 years
- Certain heart conditions including severe heart failure, recent heart attack, unstable angina, uncontrolled arrhythmia, or significant conduction problems
- Baseline ECG showing QTcF greater than 480 msec
- Inability to swallow capsules or significant gastrointestinal dysfunction
- Use of strong CYP3A inducers
- Pregnancy, breastfeeding, or planning pregnancy
- Severe or uncontrolled medical conditions affecting study participation or adherence
- Inability to comply with study restrictions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Not Yet Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Active, Not Recruiting
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
Mayo Clinic
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
6
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
D
Dana-Farber Cancer Institute Clinical Trials
CONTACT
C
Clare Phinney
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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