Zanubrutinib + Bendamustine + Rituximab for Waldenstrom Macroglobulinemia
(ZEBRA Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Andrew Branagan, MD, PhD | Mass General ...

Overseen byAndrew Branagan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

Ability to understand and sign a written informed consent document

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

My organ and bone marrow functions are within required levels.

+9 more

Exclusion Criteria

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

Pregnant, breastfeeding, planning pregnancy, or breastfeeding during the study

History of non-compliance to medical regimens

+18 more

Participant Groups

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.

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.

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

🇺🇸 Approved in United States as Treanda for: