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Alkylating agents

Zanubrutinib + Rituximab vs Bendamustine + Rituximab for Mantle Cell Lymphoma (MANGROVE Trial)

Brest, France

Phase 3

Waitlist Available

Research Sponsored by BeiGene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior systemic treatments for MCL

Histologically confirmed diagnosis of MCL

Must not have

Active fungal, bacterial and/or viral infection requiring systemic therapy

Unable to swallow capsules or disease significantly affecting gastrointestinal function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 7 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare two treatments for mantle cell lymphoma in people who are not eligible for stem cell transplantation. One treatment is zanubrutinib plus rituximab, and the other is bendamustine plus rituximab. The trial will compare how well each treatment works and how safe each is.

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Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects include reactions at the infusion site from rituximab; zanubrutinib may cause bruising, diarrhea, muscle pain; bendamustine can lead to low blood counts increasing infection risk, nausea. Side effects vary based on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not received any systemic treatments for my MCL.

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

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I can take care of myself and am up and about more than half of my waking hours.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for a serious infection.

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I cannot swallow pills or have major digestive issues.

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

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I have a serious heart condition.

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My lymphoma has spread to my brain or spinal cord.

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I have a history of severe bleeding problems.

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I am currently on medication that strongly affects liver enzyme activity.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS) determined by independent central review

Secondary study objectives

Duration of response (DOR)

Number of participants with adverse events and serious adverse events

Overall response rate (ORR)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A: zanubrutinib plus rituximabExperimental Treatment2 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 rituximabActive Control2 Interventions

Participants will receive bendamustine plus rituximab, followed by observation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

rituximab

2000

Completed Phase 3

~2760

0 / 10Eligibility criteria met