BRAZAN Trial for Initial Treatment of Mantle Cell Lymphoma (MCL)

Sponsor: Christine Ryan

Sponsor score: 0

ClinicalTrials ID:NCT06854003

Provider View

This clinical trial is testing a new combination of drugs to see if they can effectively treat Mantle Cell Lymphoma (MCL) and prevent it from returning. The study involves an initial treatment phase followed by a maintenance phase, using a mix of chemotherapy and immunotherapy drugs.

Patient Parameters

Program Overview

The study is exploring a new treatment plan for Mantle Cell Lymphoma (MCL) that combines several drugs: Bendamustine, Rituximab, Cytarabine, and Zanubrutinib (BRAZAN). After the initial treatment, participants will continue with maintenance therapy using Zanubrutinib and Rituximab, with or without an additional drug called Sonrotoclax. The goal is to see if these treatments can help control MCL and delay its return.

Description

This Phase 2 study is being conducted at multiple centers and involves randomly assigning participants to different treatment groups. The initial treatment phase includes a combination of Bendamustine, Rituximab, Cytarabine, and Zanubrutinib. After this phase, participants will be divided into two groups for maintenance therapy: one group will receive Zanubrutinib and Rituximab, while the other group will receive Zanubrutinib, Rituximab, and Sonrotoclax. The study aims to determine if these treatments can extend the time before MCL returns after initial therapy.

The drugs Bendamustine, Cytarabine, Rituximab, and Zanubrutinib are already approved by the FDA for treating other types of lymphomas and blood cancers. Rituximab and Zanubrutinib are approved for MCL, but Sonrotoclax is not yet approved for MCL, although it works similarly to another drug used for blood cancers.

Participants will undergo various procedures, including eligibility screening, treatment visits, heart and imaging tests, and biopsies. The initial treatment phase will last about 5 months, followed by up to 2 years of maintenance therapy. Approximately 60 people are expected to participate in this study, which is supported by BeiGene, Ltd., a pharmaceutical company providing some of the study drugs.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of Mantle Cell Lymphoma (MCL).
  • No previous treatment for MCL, except for certain types of radiotherapy or short-term steroids.
  • Measurable disease with specific size criteria for tumors.
  • Good overall health with an ECOG performance status of 0-2.
  • Age 18 or older and suitable for high-dose cytarabine treatment.
  • Adequate blood cell counts and organ function.
  • Controlled HIV infection, if applicable.
  • Willingness to provide a tumor sample for testing.
  • Agreement to use effective birth control during and after treatment for specified periods.
  • Ability to understand and sign a consent form.

Exclusion Criteria

  • Cancer spread to the brain or central nervous system.
  • Active infection requiring treatment at the start of the trial.
  • Recent major surgery or injury.
  • Need for certain blood thinners like warfarin.
  • History of severe bleeding disorders or recent significant bleeding events.
  • Recent stroke or brain bleeding.
  • Uncontrolled autoimmune blood disorders.
  • Active hepatitis C or B infections, unless controlled.
  • History of other cancers unless treated and disease-free for 3 years.
  • Certain heart conditions or uncontrolled high blood pressure.
  • Inability to swallow pills or digestive issues affecting medication absorption.
  • Use of certain medications that interact with the study drugs.
  • Pregnancy, breastfeeding, or plans to become pregnant.
  • Severe medical conditions affecting study participation.
  • Inability to follow study requirements.

Locations

FACILITYZIPCITYSTATE
Brigham and Women's Hospital02215BostonMassachusetts
Dana-Farber Cancer Institute02215BostonMassachusetts

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