NCT05640102

Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia

A Phase 4, Observational Study Evaluating the Efficacy and Safety of the Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib in Patients With Waldenström Macroglobulinemia

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 111 (estimated)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a hybrid (retrospective and prospective) non-interventional registry study to further describe the clinical profile of zanubrutinib in Waldenström macroglobulinemia (WM) participants with and without specific mutations and from racial and ethnic minority groups. Data collected from this registry study will be used to better understand the clinical benefit and safety of zanubrutinib for the treatment of participants in these populations.

Conditions

• Waldenstrom Macroglobulinemia

Interventions

Type	Name	Description
DRUG	Zanubrutinib	Dosing and treatment duration are at the discretion of the prescribing physician and in accordance with local labeling

Timeline

• Start date: 2023-03-03
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2022-12-07
• Last updated: 2026-03-04

Locations

8 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study