Zanubrutinib + Rituximab vs Bendamustine + Rituximab for Mantle Cell Lymphoma

(MANGROVE Trial)

Recruiting at 318 trial locations

Overseen By BeiGene

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: BeiGene

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 7 years

510 Participants Needed

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either zanubrutinib plus rituximab or bendamustine plus rituximab. Zanubrutinib monotherapy continues until disease progression for Arm A, while Arm B is followed by observation.

Up to approximately 7 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 7 years

Treatment Details

Interventions

• Bendamustine
• Rituximab
• Zanubrutinib

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 United States, European Union, Canada, Japan for the following indications:

Approved in United States as Treanda for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma

Approved in European Union as Ribomustin for:

• Chronic lymphocytic leukemia
• Non-Hodgkin lymphoma
• Multiple myeloma

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+