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.
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.
Evidence of disease transformation at the time of study entry.
Central nervous system (CNS) involvement by WM. Patients with a history of CNS involvement must undergo magnetic resonance imaging (MRI) and cerebrospinal fluid cytology studies to document no evidence of CNS disease prior to study entry.
Evidence of disease transformation at the time of study entry.
Active cardiac ischemia (eg, cardiac chest pain) ≤ 28 days before first dose of study drug.