OncoMatch/Clinical Trials/NCT07169331
A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglobulinemia
Is NCT07169331 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies Zanubrutinib for waldenström's macroglobulinemia.
Treatment: Zanubrutinib — 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.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: corticosteroids (antineoplastic intent)
Corticosteroids given with antineoplastic intent within 7 days
Cannot have received: chemotherapy
chemotherapy...within 4 weeks before the start of study drug
Cannot have received: targeted therapy
targeted therapy...within 4 weeks before the start of study drug
Cannot have received: radiation therapy
radiation therapy within 4 weeks before the start of study drug
Cannot have received: antibody-based therapy
antibody-based therapy within 4 weeks before the start of study drug
Lab requirements
Blood counts
ANC ≥ 0.75 x 10^9/L; Platelets ≥ 50 x 10^9/L; no blood transfusion or growth factor support ≤ 7 days before sample collection
Kidney function
Creatinine clearance of ≥ 30 ml/min as estimated by the Cockcroft-Gault formula
Liver function
AST and ALT ≤ 3 x ULN; serum total bilirubin ≤ 2 x ULN (total bilirubin must be < 3 x ULN for participants with Gilbert syndrome)
Participants must have adequate organ function as indicated by the following laboratory values ≤ 7 days before the first dose of study treatment: ANC ≥ 0.75 x 10^9/L; Platelets ≥ 50 x 10^9/L; Creatinine clearance of ≥ 30 ml/min; AST and ALT ≤ 3 x ULN; Serum total bilirubin ≤ 2 x ULN (total bilirubin must be < 3 x ULN for participants with Gilbert syndrome)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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