NCT06561347

Zanubrutinib, Bendamustine, Rituximab Prev. Untreated WM

A Phase 2 Multicenter Study of the Combination Zanubrutinib, Bendamustine, and Rituximab in Previously Untreated Waldenström Macroglobulinemia (ZEBRA Trial)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is multi-center phase 2 of zanubrutinib, bendamustine, and rituximab (ZBR) in previously untreated Waldenström macroglobulinemia (WM). A phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved bendamustine and rituximab for your specific disease, but it has been approved for other uses. The U.S. FDA has approved zanubrutinib as a treatment option for your disease. The combination of zanubrutinib, bendamustine, and rituximab is not approved regimen for Waldenström macroglobulinemia (WM) and is investigational in this study. Participation is expected for a maximum of 15 cycles and follow-up for up to 5 years. It is expected that about 50 people will take part in this research study.

Conditions

• Waldenstrom Macroglobulinemia

Interventions

Type	Name	Description
DRUG	Zanubrutinib	A potent, specific, and irreversible Bruton tyrosine kinase (BTK) inhibitor
DRUG	Bendamustine	Alkylating agent
DRUG	Rituximab	Monoclonal antibody

Timeline

• Start date: 2024-12-20
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2024-08-20
• Last updated: 2026-03-31

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study