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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
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 5 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.
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.
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.
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 belowSelect...
I have not received any systemic treatments for my MCL.
Select...
My diagnosis of mantle cell lymphoma is confirmed by tissue analysis.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently being treated for a serious infection.
Select...
I cannot swallow pills or have major digestive issues.
Select...
My treatment goal is to reduce my tumor size before a stem cell transplant.
Select...
I have a serious heart condition.
Select...
My lymphoma has spread to my brain or spinal cord.
Select...
I have a history of severe bleeding problems.
Select...
I am currently on medication that strongly affects liver enzyme activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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: 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
Find a Location
Who is running the clinical trial?
BeiGeneLead Sponsor
197 Previous Clinical Trials
30,226 Total Patients Enrolled
34 Trials studying Lymphoma
4,909 Patients Enrolled for Lymphoma
Rebecca Elstrom, MDStudy DirectorBeiGene
7 Previous Clinical Trials
242 Total Patients Enrolled
5 Trials studying Lymphoma
186 Patients Enrolled for Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently being treated for a serious infection.I cannot swallow pills or have major digestive issues.I have not received any systemic treatments for my MCL.My treatment goal is to reduce my tumor size before a stem cell transplant.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.I have a serious heart condition.I can take care of myself and am up and about more than half of my waking hours.My lymphoma has spread to my brain or spinal cord.I have a history of severe bleeding problems.My blood and organs are working well.I am currently on medication that strongly affects liver enzyme activity.
Research Study Groups:
This trial has the following groups:- Group 1: bendamustine plus rituximab
- Group 2: zanubrutinib plus rituximab
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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