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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

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

Clinicopathological diagnosis of waldenström macroglobulinemia (WM) per the second international workshop on waldenström macroglobulinemia (IWWM2) criteria

Must not have

Concurrent systemic immunosuppressant therapy, except for permitted doses of systemic steroids

Recent live, attenuated vaccination

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to 5 years post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see how many participants with Waldenström macroglobulinemia (a type of blood cancer) achieve a very good partial response or better. The study involves using three drugs

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 below

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My cancer has a specific genetic mutation (MYD88 or CXCR4).

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I have been diagnosed with Waldenström macroglobulinemia according to IWWM2 criteria.

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I have not received any treatment for Waldenstrom macroglobulinemia (WM).

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I will undergo a procedure to remove excess plasma from my blood if needed before starting treatment.

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I can care for myself but may not be able to do active work.

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I will use condoms during sex with women who can become pregnant.

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I have symptoms or conditions like fever, weight loss, or low blood counts that require treatment.

Exclusion Criteria

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

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I am not on any immune-suppressing drugs, except for low-dose steroids.

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I have recently received a live vaccine.

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I do not have any uncontrolled infections or serious illnesses.

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I cannot swallow pills.

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

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I have an active hepatitis B or C infection.

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I have a known history of HIV.

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I have an active autoimmune condition affecting my red blood cells or platelets.

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I am currently taking warfarin.

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I do not have severe bleeding disorders, recent stroke, or brain bleeding.

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I have serious heart problems that are not well-managed.

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I have severe lung disease.

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My brain or spinal cord is affected by Waldenstrom macroglobulinemia.

Timeline

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to 5 years post treatment for reporting.

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 more

Awards & Highlights

No Placebo-Only Group

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

Trial 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

Zanubrutinib

2017

Completed Phase 3

~2160

Bendamustine

2015

Completed Phase 3

~3230