A Phase 2 Study of Bendamustine, Rituximab, Cytarabine, and Zanubrutinib With or Without Sonrotoclax in People With Mantle Cell Lymphoma

Full Title

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

Purpose

This clinical trial explores a novel approach to treating mantle cell lymphoma (MCL). Researchers are integrating targeted agents into standard induction and maintenance chemoimmunotherapy.  The people in this study have MCL that has not yet been treated.

Patients receive zanubrutinib, a BTK inhibitor, during both the induction and maintenance phases. They may also receive sonrotoclax, a BCL2 inhibitor, during maintenance therapy. These drugs are oral medicines that target survival pathways of MCL cells. During the maintenance phase, 2 different treatment approaches are being studied. 

If you take part in this study, you will first get initial treatment with zanubrutinib, bendamustine, rituximab, and cytarabine. You will then be randomly assigned to one of these maintenance therapies:

• Zanubrutinib and rituximab
• Zanubrutinib, rituximab, and sonrotoclax

Maintenance therapy is given to keep MCL from coming back or getting worse. All of these medications are given intravenously (by vein), except for zanubrutinib and sonrotoclax, which are taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

• Be newly diagnosed with MCL that has not yet been treated.
• Be able to walk and do routine activities for more than half the time you are awake.
• Be age 18 or older.

Contact

For more information about this study or to see if you can join, please call Dr. Anita Kumar’s office at 646-608-3780.