Actively Recruiting
Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia
Led by BeiGene · Updated on 2026-03-04
111
Participants Needed
8
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a hybrid (retrospective and prospective) non-interventional registry study to further describe the clinical profile of zanubrutinib in Waldenström macroglobulinemia (WM) participants with and without specific mutations and from racial and ethnic minority groups. Data collected from this registry study will be used to better understand the clinical benefit and safety of zanubrutinib for the treatment of participants in these populations.
CONDITIONS
Official Title
Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical and definitive histologic diagnosis of WM
- Measurable disease with serum immunoglobulin M (IgM) level > 0.5 g/dL at zanubrutinib start
- Started, currently treated, or planned to be treated with zanubrutinib for WM
- Bone marrow specimens with central MYD88 test results for:
- Cohort 1: MYD88 L265P mutation; enrollment of treatment-naive participants will stop when required numbers per racial and ethnic group are met
- Cohort 2: non-L265P MYD88 mutations or MYD88 wild-type
You will not qualify if you...
- Evidence of disease transformation before first zanubrutinib dose
- Evidence of other non-Hodgkin lymphoma subtypes
- Prior or concurrent active malignancy within 2 years before first zanubrutinib dose, except if deemed not to affect safety or efficacy interpretation
- Concurrent participation in another therapeutic clinical study while receiving zanubrutinib unless approved by Medical Monitor
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805-2606
Actively Recruiting
2
South Alabama Medical Science Foundation Mitchell Cancer Institute
Mobile, Alabama, United States, 36604-1405
Actively Recruiting
3
City of Hope National Medical Center
Duarte, California, United States, 91010-3012
Actively Recruiting
4
Los Angeles Cancer Network (Lacn)
Glendale, California, United States, 91204-3640
Actively Recruiting
5
Eisenhower Medical Center, Lucy Curci Cancer Center
Rancho Mirage, California, United States, 92270-3221
Actively Recruiting
6
Hattiesburg Hematology and Oncology Clinic
Hattiesburg, Mississippi, United States, 39401-7233
Actively Recruiting
7
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169-3321
Actively Recruiting
8
Pan American Oncology Trials, Llc
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
Research Team
S
Study Director
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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