Status:
RECRUITING
A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglobulinemia
Lead Sponsor:
BeiGene
Conditions:
Waldenström's Macroglobulinemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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:
- 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.
- Creatinine clearance of ≥ 30 ml/min as estimated by the Cockcroft-Gault formula.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN).
- Serum total bilirubin ≤ 2 x ULN (total bilirubin must be \< 3 x ULN for participants with Gilbert syndrome).
- Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for at least 1 month after the last dose of zanubrutinib. They must also have a negative urine or serum pregnancy test result ≤ 7 days before the first dose of study treatment.
Exclusion
- 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.
- Participants with any of the following cardiovascular risk factors:
- Active cardiac ischemia (eg, cardiac chest pain) ≤ 28 days before first dose of study drug.
- Any history of acute myocardial infarction ≤ 6 months before the first dose of study drug.
- Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV (Appendix 7)≤ 6 months before the first dose of study drug.
- Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before the first dose of study drug.
- Active, clinically significant second-degree atrioventricular block Mobitz II, or third degree atrioventricular block.
- Any history of cerebrovascular accident ≤ 6 months before the first dose of study drug.
- Uncontrolled hypertension that cannot be managed by standard antihypertension medications ≤ 28 days before the first dose of study drug.
- Any episode of syncope or seizure ≤ 28 days before first dose of study drug.
- At the time of study entry, participants taking warfarin or other vitamin K antagonists.
- Participants requiring ongoing therapy with strong or moderate cytochrome CYP3A inducers
- Corticosteroids given with antineoplastic intent within 7 days, or chemotherapy, targeted therapy, or radiation therapy within 4 weeks, or antibody-based therapy within 4 weeks before the start of study drug.
- Major surgical procedure within 4 weeks before the start of study treatment (bone marrow aspirate and biopsy procedures are not considered major surgical procedures).
- Note: Other protocol defined criteria may apply
Key Trial Info
Start Date :
October 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2028
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT07169331
Start Date
October 17 2025
End Date
October 31 2028
Last Update
December 19 2025
Active Locations (8)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
2
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
3
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
4
Affiliated Hospital of Hebei University
Baoding, Hebei, China, 071000