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Alkylating agents
Zanubrutinib + Bendamustine + Rituximab for Waldenstrom Macroglobulinemia (ZEBRA Trial)
Phase 2
Waitlist Available
Led By Andrew Branagan, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Clinicopathological diagnosis of waldenström macroglobulinemia (WM) per the second international workshop on waldenström macroglobulinemia (IWWM2) criteria
* Presence of any MYD88 and CXCR4 mutation status, including MYD88 L265P mutation plus CXCR4 wild type, MYD88 L265P mutation plus CXCR4 mutation, or MYD88 wild type
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to 5 years post treatment
Awards & highlights
Summary
The purpose of this study is to determine the very good partial response (VGPR) or better rate in participants with Waldenström macroglobulinemia (WM). The names of the study drugs involved in this study are as follows: zanubrutinib, bendamustine, and rituximab.
Who is the study for?
This trial is for individuals with Waldenstrom Macroglobulinemia, a type of cancer that affects white blood cells and can cause anemia, thickened blood, and other issues. The study is seeking participants who have not been treated before.
What is being tested?
The study aims to evaluate the effectiveness of a combination treatment using zanubrutinib, bendamustine, and rituximab in achieving a very good partial response or better in patients with WM.
What are the potential side effects?
Potential side effects may include nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, allergic reactions during infusion treatments, and possibly others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to 5 years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to 5 years post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Very Good Partial Response (VGPR) or Better Response Rate
Secondary study objectives
Complete Response Rate
Major Response Rate
Median Time to Major Response
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Zanubrutinib + Bendamustine + RituximabExperimental Treatment3 Interventions
Zanubrutinib will be taken orally once daily on days 1-28 of cycles 1-15.
Bendamustine will be given by intravenous infusion over about 10 to 60 minutes on days 1 and 2 of cycles 1 to 4.
Rituximab will be given by intravenous infusion over about 30 minutes on day 1 of cycles 1 to 4.
Drug diaries will be provided to participants to document information about the study treatment being taken.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bendamustine
2015
Completed Phase 3
~3240
Rituximab
1999
Completed Phase 4
~2200
Zanubrutinib
2017
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,979 Previous Clinical Trials
13,220,245 Total Patients Enrolled
4 Trials studying Waldenstrom Macroglobulinemia
262 Patients Enrolled for Waldenstrom Macroglobulinemia
BeiGeneIndustry Sponsor
185 Previous Clinical Trials
29,431 Total Patients Enrolled
9 Trials studying Waldenstrom Macroglobulinemia
1,051 Patients Enrolled for Waldenstrom Macroglobulinemia
Andrew Branagan, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
160 Total Patients Enrolled
1 Trials studying Waldenstrom Macroglobulinemia
160 Patients Enrolled for Waldenstrom Macroglobulinemia
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