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
Christine Ryan
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)
Description
This Phase 2, multi-center, randomized study is 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 MCL. These specific maintenance therapy combinations are investigational and are being evaluated to see if the therapies may lengthen the time before MCL returns after initial therapy. After completing induction therapy, participants will be randomized into one of two groups: Arm A: zanubrutinib…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically confirmed diagnosis of mantle cell lymphoma, with review of the diagnostic pathology specimen at one of the participating institutions. Whenever possible, the Ki67 fraction should be reported or evaluated, cytogenetics should be performed, and TP53 status should be assessed (preferably by next-generation sequencing; immunohistochemical staining would be next-preferred). * No prior anti-lymphoma therapy, with the following exceptions: * Prior radiotherapy for localized disease is permitted. * A course of radiotherapy for urgent symptomatic disease is a…
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 ArizonaPhoenix, Arizona
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Brigham and Women's HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Mayo ClinicRochester, Minnesota
- Washington UniversitySt Louis, Missouri