NCT06942507

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

A Multicenter Study on the First-line Treatment of Waldenström's Macroglobulinemia With Zanubrutinib in Combination With Rituximab and Bendamustine

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Waldenström's Macroglobulinemia (WM)

Interventions

Type	Name	Description
DRUG	Zanubrutinib	zanubrutinib 160mg po bid d1-28
DRUG	Bendamustine + Rituximab	bendamustine 70-90mg/m2 ivgtt d1-2, rituximab 375mg/m2 ivgtt d1

Timeline

• Start date: 2025-05-01
• Primary completion: 2027-04-30
• Completion: 2029-04-30
• First posted: 2025-04-24
• Last updated: 2025-04-30

Locations

1 site across 1 country: China