Zanubrutinib + Rituximab vs Bendamustine + Rituximab for Mantle Cell Lymphoma

(MANGROVE Trial)

Recruiting at 318 trial locations

Overseen By BeiGene

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: BeiGene

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.

Research Team

Study Director

Principal Investigator

BeiGene

Eligibility Criteria

This trial is for people aged 70 or older, or those 60-69 with health issues preventing stem cell transplant. They must have untreated mantle cell lymphoma confirmed by tests, be able to perform daily activities (ECOG 0-2), and not have infections needing systemic treatment, CNS lymphoma involvement, plans for tumor debulking before a transplant, severe heart disease, bleeding disorders, or gastrointestinal problems affecting drug absorption.

Inclusion Criteria

I have not received any systemic treatments for my MCL.

I am 70 or older, or I am between 60 and 70 with health issues preventing a specific stem cell treatment.

My diagnosis of mantle cell lymphoma is confirmed by tissue analysis.

Exclusion Criteria

I am currently being treated for a serious infection.

I cannot swallow pills or have major digestive issues.

My treatment goal is to reduce my tumor size before a stem cell transplant.

Treatment Details

Interventions

• Bendamustine (Alkylating agents)
• Rituximab (Monoclonal Antibodies)
• Zanubrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)

Trial Overview The study compares two treatments: Zanubrutinib plus Rituximab versus Bendamustine plus Rituximab in patients who haven't been treated for mantle cell lymphoma and can't undergo stem cell transplantation. It's randomized so participants are put into groups by chance to see which treatment works better and is safer.

Participant Groups

Group I: Arm A: zanubrutinib plus rituximab Experimental Treatment 2 Interventions

Participants will receive zanubrutinib plus rituximab, followed by zanubrutinib monotherapy until Independent Review Committee (IRC)-confirmed disease progression.

Group II: Arm B: bendamustine plus rituximab Active Control 2 Interventions

Participants will receive bendamustine plus rituximab, followed by observation.

Bendamustine is already approved in Canada, Japan for the following indications:

Approved in Canada as Levact for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma

Approved in Japan as Bendamustine hydrochloride for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+