Actively Recruiting
Zanubrutinib, Bendamustine, Rituximab Prev. Untreated WM
Led by Massachusetts General Hospital · Updated on 2026-03-31
55
Participants Needed
5
Research Sites
153 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
B
BeiGene
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Zanubrutinib, Bendamustine, Rituximab Prev. Untreated WM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Waldenstr�f6m macroglobulinemia according to established criteria
- Any MYD88 and CXCR4 mutation status
- Meeting treatment criteria including symptoms like recurrent fever, night sweats, fatigue, weight loss, or clinical signs such as lymphadenopathy, splenomegaly, low hemoglobin or platelets, hyperviscosity syndrome, peripheral neuropathy, amyloidosis, renal insufficiency, or cryoglobulinemia
- No prior systemic therapy for Waldenstr�f6m macroglobulinemia
- Adults aged 18 years and older
- ECOG performance status 0 to 2
- Women of childbearing potential must use two reliable contraception methods or abstain from heterosexual intercourse during and after treatment
- Men must agree to use condoms during sexual contact with women of childbearing potential during and after treatment
- Adequate organ and marrow function including specific blood counts and liver and kidney function
- Ability to adhere to study schedule and provide informed consent
You will not qualify if you...
- Serious medical or psychiatric conditions preventing consent
- Pregnant or breastfeeding women
- Known central nervous system involvement of Waldenstr�f6m macroglobulinemia
- Known HIV infection
- Active hepatitis B or C infection
- Use of systemic immunosuppressants beyond low-dose steroids
- Active autoimmune anemia or thrombocytopenia
- Use of warfarin or derivatives
- Vaccination with live vaccines within 4 weeks before study drug
- Active uncontrolled infections or significant disease making participation unsafe
- Major surgery within 4 weeks before study drug
- Severe bleeding disorders or recent stroke
- Inability to swallow pills
- Inability to comply with treatment and monitoring
- Significant uncontrolled cardiovascular disease
- Known allergy to study drugs or their excipients
- History of non-compliance to medical treatments
- Recent malignancy within 3 years except certain skin or localized cancers
- Severe pulmonary disease
- Ongoing substance addiction or psychiatric conditions affecting compliance
- Use of strong CYP3A inducers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Colorado Blood Cancer Institute (CBCI)
Denver, Colorado, United States, 80218
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
A
Andrew Branagan, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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