drugset / Trial / NCT06942507

Zanubrutinib Combined With BR in the First-line Treatment of Waldenström's Macroglobulinemia

NCT06942507

Not yet recruiting 104 enrolled Peking Union Medical College Hospital
NaSingle-groupOpen-labelTreatment

Summary

Current retrospective studies have demonstrated that achieving deep remission following treatment for Waldenström's macroglobulinemia (WM) correlates with prolonged survival. While the bendamustine-rituximab (BR) regimen or single-agent zanubrutinib are currently recommended as first-line therapies, neither achieves optimal deep remission. Additionally, prolonged zanubrutinib monotherapy may lead to cumulative adverse effects. Therefore, this study aims to evaluate the efficacy and safety of the bendamustine-rituximab-zanubrutinib combination regimen as a first-line treatment option for MYD88-mutated WM patients.

Timeline

Start
2025-05-01
Primary completion
2027-04-30
Completion
2029-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bendamustine Small molecule 70 mg/m2 Intravenous
Subject Bendamustine Small molecule 90 mg/m2 Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Zanubrutinib Small molecule 160 mg Oral