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NCT05640102
Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia
Conditions: Waldenstrom Macroglobulinemia
Sex: All
Ages: 18 Years – N/A
Enrollment: 111
Sponsor: BeiGene
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
Inclusion Criteria:Clinical and definitive histologic diagnosis of WMMeasurable disease, as defined by a serum immunoglobulin M (IgM) level > 0.5 g/dL at the time of zanubrutinib initiationStarted treatment with zanubrutinib, has been treated with zanubrutinib, or is planned to be prescribed zanubrutinib for the treatment of WMBone 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 metCohort 2: non-L265P MYD88 mutation(s) and MYD88WTExclusion Criteria:Evidence of disease transformation before the first dose of zanubrutinibEvidence of other non-Hodgkin Lymphoma (NHL) subtypesPrior 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 resultsConcurrent 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
Source: ClinicalTrials.gov (NCT05640102). StuddyBuddy aggregates publicly available trial information.