510 Participants Needed

Zanubrutinib + Rituximab vs Bendamustine + Rituximab for Mantle Cell Lymphoma

(MANGROVE Trial)

Recruiting at 318 trial locations
B
Overseen ByBeiGene
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

SD

Study Director

Principal Investigator

BeiGene

Are You a Good Fit for This Trial?

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.
See 3 more

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.
See 4 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: zanubrutinib plus rituximabExperimental Treatment2 Interventions
Group II: Arm B: bendamustine plus rituximabActive Control2 Interventions

Bendamustine is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Treanda for:
🇪🇺
Approved in European Union as Ribomustin for:
🇨🇦
Approved in Canada as Levact for:
🇯🇵
Approved in Japan as Bendamustine hydrochloride for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials
216
Recruited
32,500+
Unbiased ResultsWe believe in providing patients with all the options.
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