A Phase 4, Observational Study Evaluating the Efficacy and Safety of the Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib in Patients With Waldenström Macroglobulinemia
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. Coh…
Interventions
- DrugZanubrutinib
Dosing and treatment duration are at the discretion of the prescribing physician and in accordance with local labeling
Locations (8)
- Clearview Cancer InstituteHuntsville, Alabama
- South Alabama Medical Science Foundation Mitchell Cancer InstituteMobile, Alabama
- City of Hope National Medical CenterDuarte, California
- Los Angeles Cancer Network (Lacn)Glendale, California
- Eisenhower Medical Center, Lucy Curci Cancer CenterRancho Mirage, California
- Hattiesburg Hematology and Oncology ClinicHattiesburg, Mississippi