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
Christine Ryan
60 participants
Apr 22, 2025
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
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Interventions
An Alkylating agent, multi-dose vial, via intravenous (into the vein) infusion per institutional standard of care.
An Anti-CD20 antibody, single-use vials, via intravenous infusion per institutional standard of care.
An Antineoplastic, single dose vial via intravenous infusion per institutional standard of care.
A BTK inhibitor, capsule taken orally per protocol.
A BCL 2 Protein Inhibitor, immediate release tablet, taken orally per protocol.
Locations(7)
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NCT06854003