A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglobulinemia
NCT ID: NCT07169331
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
18 participants
INTERVENTIONAL
2025-10-17
2028-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Zanubrutinib
Participants will receive 160 mg zanubrutinib orally twice a day until progressive disease, unacceptable toxicity or death, withdrawal of consent, loss to follow-up, or study termination by the sponsor for any reason.
Zanubrutinib
Administered orally
Interventions
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Zanubrutinib
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN).
4. 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 Criteria
* 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:
1. Active cardiac ischemia (eg, cardiac chest pain) ≤ 28 days before first dose of study drug.
2. Any history of acute myocardial infarction ≤ 6 months before the first dose of study drug.
3. 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.
4. Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before the first dose of study drug.
5. Active, clinically significant second-degree atrioventricular block Mobitz II, or third degree atrioventricular block.
6. Any history of cerebrovascular accident ≤ 6 months before the first dose of study drug.
7. Uncontrolled hypertension that cannot be managed by standard antihypertension medications ≤ 28 days before the first dose of study drug.
8. 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
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Yichang Central Peoples Hospital
Yichang, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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BGB-3111-404
Identifier Type: -
Identifier Source: org_study_id