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Alkylating agents

Zanubrutinib + Rituximab vs Bendamustine + Rituximab for Mantle Cell Lymphoma

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years

Awards & highlights

Study 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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 years

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Duration of response (DOR)

Occurrence and severity of treatment-emergent adverse events (safety and tolerability)

Overall response rate (ORR)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: zanubrutinib plus rituximabExperimental Treatment2 Interventions

Group II: bendamustine plus rituximabActive Control2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

rituximab

2000

Completed Phase 3

~2760

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor

175 Previous Clinical Trials

28,304 Total Patients Enrolled

Rebecca Elstrom, MDStudy DirectorBeiGene

7 Previous Clinical Trials

584 Total Patients Enrolled

Media Library

Bendamustine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04002297 — Phase 3

Mantle Cell Lymphoma Research Study Groups: bendamustine plus rituximab, zanubrutinib plus rituximab

Mantle Cell Lymphoma Clinical Trial 2023: Bendamustine Highlights & Side Effects. Trial Name: NCT04002297 — Phase 3

Bendamustine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04002297 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being enrolled in this clinical trial?

"The information available on clinicaltrials.gov appears to show that this trial is still looking for volunteers. This specific study was originally posted on 8/21/2019, and the most recent update was on 9/6/2022. They are hoping to enroll 500 patients from 18 different locations."

Answered by AI

How many individuals are currently being treated as part of this clinical research?

"500 individuals that fit the pre-determined inclusion criteria are required for this experiment. These participants can come from various hospitals, such as The Ottawa Hospital in Ottawa, Ontario or University of California Irvine Health in Orange, California."

Answered by AI

What is the zanubrutinib research landscape like?

"Zanubrutinib was first studied in 1993 at the National Institutes of Health Clinical Center. 893 studies have been completed to date, with 481 clinical trials currently active. A large volume of these studies are based in Ottawa, Ontario."

Answered by AI

Is this clinical trial only available in certain areas?

"To 18 different locations, this study is currently recruiting patients. The sites are based in cities including Ottawa, Orange, Orlando and others. If you wish to participate in this clinical trial, it would be best to select the site that is closest to you to limit travel."

Answered by AI

Is zanubrutinib a safe medication for consumers?

"Zanubrutinib's safety is highly likely, as it is a Phase 3 trial medication. This means that not only is there some evidence of the drug's efficacy, but also that it has undergone multiple rounds of safety testing."

Answered by AI

What are some of the main conditions that zanubrutinib has been shown to improve?

"Zanubrutinib is not only useful in the treatment of relapsed marginal zone lymphoma, but also in treating other blood disorders like diffuse large b-cell lymphoma (DLBCL), hodgkin disease, and various subtypes of B-cell lymphomas."

Answered by AI