A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naiv… (NCT07169331) | Clinical Trial Compass
RecruitingPhase 4
A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglobulinemia
China18 participantsStarted 2025-10-17
Plain-language 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 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participants must not have required blood transfusion or growth factor support ≤ 7 days before sample collection at screening for the following:
✓. 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).
Exclusion criteria
✕. 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.
âś•. 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.
What they're measuring
1
Percentage of Participants Achieving a Complete Response (CR) or Very Good Partial Response (VGPR) as Assessed by the Investigator