RecruitingWaldenstrom Macroglobulinemia
Zanubrutinib, Bendamustine, Rituximab Prev. Untreated WM
Eligible age
18+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Massachusetts General Hospital
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent the participant from signing the informed consent form
- ✕ Female participants who are pregnant, breastfeeding, or planning to become pregnant or breastfeed while enrolled in this study
- ✕ Participants with known CNS involvement by WM
- ✕ Participants with known history of Human Immunodeficiency Virus (HIV)
- ✕ Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below:
- ✕ Hepatitis B virus (HBV): Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (antiHBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation before enrollment. Patients who are hepatitis B PCR positive will be excluded.
- ✕ Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before enrollment. Patients who are hepatitis C RNA positive will be excluded.
- ✕ Concurrent systemic immunosuppressant therapy. Systemic steroids at doses \<20mg prednisone per day are permitted.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06561347 · last updated 2026-06-08