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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Christine Ryan
Study ID
NCT06854003
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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)

Key Dates

Start date
Apr 22, 2025
Status verified
Feb 2026
Primary completion
Nov 1, 2029
Completion
Nov 1, 2039

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Induction Therapy (All Patients)
    Enrolled participants will complete: * Baseline visit with PET/CT, lymph node biopsy, and bone marrow biopsy * Cycles 1 through 3 (28-day cycles): * Days 1 - 28: Predetermined dose of Zanubrutinib 2x daily * Days 1 and 2: Predetermined dose of Bendamustine 1x daily * Day 1: Predetermined dose of Rituximab 1x daily * PET/CT scan * Cycles 4 through 6 (21-day cycles): * Day 1: Predetermined dose of Rituximab 1x daily * Days 1 and 2: Predetermined dose of Cytarabine 2x daily * PET/CT scan Participants without disease progression will proceed to randomization to either Arm A or Arm B for maintenance therapy.
  • Experimental: Maintenance Arm A: Zanubrutinib + Rituximab
    Following randomization participants with a complete response to induction therapy will complete: * Cycles 1 - 24 (28-day cycles): * Days 1 through 28: Predetermined dose of Zanubrutinib 2x daily * Day 1 every other cycle: Predetermined dose of Rituximab 1x daily * PET/CT on Cycles 7, 12, 19, and at end of treatment * Post-treatment follow up: every 6 months. PET/CT every 12 months
  • Experimental: Maintenance Arm B: Zanubrutinib + Rituximab + Sonrotoclax
    Following randomization participants with a complete response to induction therapy will complete: * Cycles 1 - 24 (28-day cycles): * Days 1 through 28: Predetermined dose of Zanubrutinib 2x daily * Days 1 through 28: Predetermined dose of Sonrotoclax 1x daily * Day 1 every other cycle: Predetermined dose of Rituximab 1x daily * PET/CT on Cycles 7, 12, 19, and at end of treatment * Post-treatment follow up: every 6 months. PET/CT every 12 months
  • Experimental: Maintenance Arm B with Sonrotoclax Ramp-Up: Zanubrutinib + Rituximab + Sonrotoclax
    Following randomization participants with an incomplete response to induction therapy will require a ramp-up initiation of sonrotoclax and will complete: * Cycles 1 - 24 (28-day cycles): * Days 1 through 28: Predetermined dose of Zanubrutinib 2x daily * Days 1 through 28: Predetermined dose of Sonrotoclax 1x daily \*\*Cycles 1 and 2: Predetermined dose of Sonrotoclax 1x daily will be increased weekly. * Day 1 every other cycle: Predetermined dose of Rituximab 1x daily * PET/CT on Cycles 7, 12, 19, and at end of treatment * Post-treatment follow up: every 6 months. PET/CT every 12 months

Primary Outcome Measure

Complete Response Rate (CRR) after 1-year of Maintenance Treatment [ Time Frame: Up to 125 weeks ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona85054
Javier L Munoz, MD MBA
[email protected]
480-515-6296
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Michael Leukam, MD
[email protected]
617-667-9920
Brigham and Women's HospitalBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215
Dana-Farber Cancer Institute Clinical Trials
[email protected]
877-DF-TRIAL (877-338-7425)
Clare Phinney
[email protected]
Christine Ryan, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Yucai Wang, MD
[email protected]
507-538-3270
Washington UniversitySt LouisMissouri63110
Brad Kahl, MD
[email protected]
314-454-8330
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Anita Kumar, MD
[email protected]
800-525-2225

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By research site
Mayo Clinic Arizona· Phoenix, AZBeth Israel Deaconess Medical Center· Boston, MABrigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MAMayo Clinic· Rochester, MNWashington University· St Louis, MO

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