A Phase 2 Multicenter Study of the Combination Zanubrutinib, Bendamustine, and Rituximab in Previously Untreated Waldenström Macroglobulinemia (ZEBRA Trial)
Massachusetts General Hospital
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.
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 combinati…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Meeting criteria for treatment per IWWM2 criteria. At least one of the following: * Constitutional Symptoms (at least one of the following) * Recurrent fever * Night sweats * Fatigue * Weight loss * Progressive or symptomatic lympha…
Interventions
- DrugZanubrutinib
A potent, specific, and irreversible Bruton tyrosine kinase (BTK) inhibitor
- DrugBendamustine
Alkylating agent
- DrugRituximab
Monoclonal antibody
Locations (5)
- Colorado Blood Cancer Institute (CBCI)Denver, Colorado
- Massachusetts General HospitalBoston, Massachusetts
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts
- University of Texas Southwestern Medical CenterDallas, Texas