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

Launched by BEIGENE · Nov 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called zanubrutinib for patients with Waldenström Macroglobulinemia (WM), a type of blood cancer. The study aims to gather information from a diverse group of participants, including those with specific genetic mutations and individuals from different racial and ethnic backgrounds. Researchers want to learn more about how well zanubrutinib works and its safety in treating WM.

To be eligible for this study, participants need to have a confirmed diagnosis of WM and measurable disease, indicated by a certain level of immunoglobulin M (IgM) in their blood. They should also have started treatment with zanubrutinib or plan to do so. However, individuals with certain other types of cancers or significant disease changes before starting zanubrutinib will not be included. Participants in the study will provide data about their experiences with the medication, which will help researchers understand its benefits and risks better.

Gender

ALL

Eligibility criteria

• 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

Trial Officials