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NCT05640102Recruiting

Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia

BeiGene

Start Date

3/3/2023

Completion Date

12/1/2027

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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: 1. 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 2. Cohort 2: non-L265P MYD88 mutation(s) and MYD88WT Exclusion Criteria: * 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

Interventions

DRUG

Zanubrutinib

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Conditions

Waldenstrom Macroglobulinemia

Locations

Clearview Cancer Institute

Huntsville, Alabama 35805-2606

United States

South Alabama Medical Science Foundation Mitchell Cancer Institute

Mobile, Alabama 36604-1405

United States

City of Hope National Medical Center

Duarte, California 91010-3012

United States

Los Angeles Cancer Network (Lacn)

Glendale, California 91204-3640

United States

Eisenhower Medical Center, Lucy Curci Cancer Center

Rancho Mirage, California 92270-3221

United States

Hattiesburg Hematology and Oncology Clinic

Hattiesburg, Mississippi 39401-7233

United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada 89169-3321

United States

Pan American Oncology Trials, Llc

Rio Piedras, 00935

Puerto Rico