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

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)

Trial Details

NCT ID

NCT06854003

Phase

PHASE2

Sponsor

Christine Ryan

Status

RECRUITING

Cancer Type

Non-Hodgkin Lymphoma Lymphoma

Interventions

Bendamustine
Rituximab
Cytarabine
Zanubrutinib
Sonrotoclax

Locations (sample)

Phoenix, Arizona, United States|33.44838,-112.07404
Boston, Massachusetts, United States|42.35843,-71.05977
Boston, Massachusetts, United States|42.35843,-71.05977
Boston, Massachusetts, United States|42.35843,-71.05977
Rochester, Minnesota, United States|44.02163,-92.4699

Key Eligibility Criteria

Histologically confirmed diagnosis of mantle cell lymphoma, with review of the diagnostic pathology specimen at one of the participating institutio…
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 also permitted. Short-course systemic corticosteroids is permissible for disease control…

For full eligibility, visit ClinicalTrials.gov.

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