Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia
Recruiting now
Conditions studied: Waldenstrom Macroglobulinemia
In brief
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.
Key facts
- Study ID
- NCT05640102
- Run by
- BeiGene
- People needed
- 111
- Starts
- 2023-03-03
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-08-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Clinical and definitive histologic diagnosis of WM
- Measurable disease, as defined by a serum immunoglobulin M (IgM) level > 0.5 g/dL at the time of zanubrutinib initiation
- Started treatment with zanubrutinib, has been treated with zanubrutinib, or is planned to be prescribed zanubrutinib for the treatment of WM
- Bone marrow specimens with central MYD88 test results of:
- Cohort 1: MYD88 L265P mutation; enrollment of TN participants will be stopped in each racial and ethnic participant group when the required numbers of participants in the group are met
- Cohort 2: non-L265P MYD88 mutation(s) and MYD88WT
You may not qualify if…
- Evidence of disease transformation before the first dose of zanubrutinib
- Evidence of other non-Hodgkin Lymphoma (NHL) subtypes
- Prior or concurrent active malignancy ≤ 2 years before the first dose of zanubrutinib, except for malignancies that, in the investigator's opinion, will not obscure the interpretation of safety or efficacy results
- Concurrent participation in another therapeutic clinical study while receiving zanubrutinib, although the participant may be eligible depending on the status of the interventional study after discussion with the Medical Monitor or designee on an individual basis
Where it is running
- Clearview Cancer Institute — Huntsville, Alabama, United States (enrolling)
- South Alabama Medical Science Foundation Mitchell Cancer Institute — Mobile, Alabama, United States (enrolling)
- City of Hope National Medical Center — Duarte, California, United States (enrolling)
- Los Angeles Cancer Network (Lacn) — Glendale, California, United States (enrolling)
- Eisenhower Medical Center, Lucy Curci Cancer Center — Rancho Mirage, California, United States (enrolling)
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States (enrolling)
- Pan American Oncology Trials, Llc — Rio Piedras, Puerto Rico
- Hattiesburg Hematology and Oncology Clinic — Hattiesburg, Mississippi, United States
Full record on ClinicalTrials.gov
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