Actively Recruiting
A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglobulinemia
Led by BeiGene · Updated on 2025-12-19
18
Participants Needed
8
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglobulinemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical and definitive histologic diagnosis of Waldenström Macroglobulinemia (WM) with no prior treatment.
- Must meet at least one treatment initiation criterion according to the Seventh International Workshop on Waldenström Macroglobulinemia.
- Measurable disease with serum immunoglobulin M (IgM) level greater than 0.5 g/dL.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- Adequate organ function confirmed by laboratory tests within 7 days before first dose, including: no blood transfusion or growth factor support within 7 days before sample collection; absolute neutrophil count ≥ 0.75 x 10^9/L; platelets ≥ 50 x 10^9/L; creatinine clearance ≥ 30 ml/min; AST and ALT ≤ 3 times upper limit of normal; total bilirubin ≤ 2 times upper limit of normal (or < 3 times for Gilbert syndrome).
- Female participants of childbearing potential must use highly effective birth control, avoid egg donation during the study and for at least one month after last dose, and have a negative pregnancy test within 7 days before first dose.
You will not qualify if you...
- Evidence of disease transformation at study entry.
- Central nervous system involvement by WM, unless confirmed absent by MRI and cerebrospinal fluid studies.
- Cardiovascular risk factors including: active cardiac ischemia within 28 days; acute myocardial infarction within 6 months; heart failure classified as NYHA III or IV within 6 months; ventricular arrhythmia ≥ Grade 2 within 6 months; certain types of atrioventricular block; cerebrovascular accident within 6 months; uncontrolled hypertension within 28 days; recent syncope or seizure within 28 days.
- Current use of warfarin or other vitamin K antagonists.
- Need for ongoing therapy with strong or moderate CYP3A inducers.
- Recent corticosteroids with antineoplastic intent within 7 days; chemotherapy, targeted therapy, or radiation therapy within 4 weeks; antibody-based therapy within 4 weeks before study drug start.
- Major surgery within 4 weeks before study treatment (excluding bone marrow aspirate and biopsy).
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
2
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
3
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
4
Affiliated Hospital of Hebei University
Baoding, Hebei, China, 071000
Actively Recruiting
5
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
6
Yichang Central Peoples Hospital
Yichang, Hubei, China, 443003
Actively Recruiting
7
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410008
Actively Recruiting
8
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
S
Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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