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.
Single group
Zanubrutinib
DrugAdministered orally
Percentage of Participants Achieving a Complete Response (CR) or Very Good Partial Response (VGPR) as Assessed by the Investigator
The percentage of participants who achieve either a complete response or very good partial response (VGPR) as determined by the investigator using an adaptation of the response criteria updated at the Sixth International Workshop on Waldenström's macroglobulinemia (IWWM).
Major Response Rate (MRR) as Assessed by the Investigator
MRR is defined as the percentage of participants achieving CR, VGPR, or partial response (PR) as determined by the investigator per the modified IWWM criteria.
Duration of Major Response (DOMR) as Assessed by the Investigator
DOMR is defined as the time from first determination of response (CR, VGPR, or PR) (per modified IWWM criteria) until first documentation of disease progression (per modified IWWM criteria) or death, whichever comes first
Progression-free Survival (PFS) as Assessed by the Investigator
Progression-free survival (PFS) as assessed by the investigator, defined as time from start of treatment to the first documentation of disease progression (per modified IWWM criteria) or death, whichever occurs first.
Number of Participant with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, physical examination findings, and electrocardiogram results.
