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 (Jun 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
Treatments studied
Targeted therapy
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.
Frequently asked questions
Is NCT07169331 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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