A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglobulinemia
Trial Parameters
Brief Summary
The purpose of this study is to measure the efficacy and safety with zanubrutinib in adults with Treatment-Naive (TN) Waldenström Macroglobulinemia (WM). The main objective of this Phase 4 study is to further characterize the efficacy of zanubrutinib in Chinese participants with TN WM in order to fulfill the post-marketing requirements from the National Medical Products Administration (NMPA). Safety data will be collected and evaluated in this study as well.
Eligibility Criteria
Inclusion Criteria: * Clinical and definitive histologic diagnosis of WM. Participant must be treatment-naive. * Participant must meet at least 1 criterion for treatment according to consensus panel criteria from the Seventh International Workshop on Waldenström's macroglobulinemia (IWWM). * Participant must have measurable disease, as defined by serum immunoglobulin M (IgM) level \> 0.5 g/dL. * Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. * Participants must have adequate organ function as indicated by the following laboratory values ≤ 7 days before the first dose of study treatment: 1. Participants must not have required blood transfusion or growth factor support ≤ 7 days before sample collection at screening for the following: * Absolute neutrophil count (ANC) ≥ 0.75 x 10\^9/L. * Platelets ≥ 50 x 10\^9/L. 2. Creatinine clearance of ≥ 30 ml/min as estimated by the Cockcroft-Gault formula. 3. Aspartate aminotransferase (AST) and alanin