drugset / Trial / NCT05979948
A Phase 2 Clinical Trial to Evaluate Zanubrutinib Combined With BR (Bendamustine/Rituximab) Regimen in Subjects With Newly-diagnosed Waldenström's Macroglobulinemia
Phase 2
Unknown
60 enrolled
Shanghai Changzheng Hospital
Huadong Hospital · collabHuashan Hospital · collabRenJi Hospital · collabShanghai 6th People's Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
This was a single-arm, multicenter, Phase 2 study to evaluate the efficacy of zanubrutinib combined with BR (Bendamustine/Rituximab) regimen in Chinese participants with newly-diagnosed Waldenström's macroglobulinemia who exhibited one or more of the criteria for requiring treatment based on consensus guidelines from the 11th International Workshop on Waldenström's Macroglobulinemia (IWWM). The investigators propose this combination will improve the deep remission compared to single Zanubrutinib or BR regimen and can be a time-limited regimen which will reduce the life-time therapy and benefit the patients.
Timeline
- Start
- 2023-08-01
- Primary completion
- 2025-04-01
- Completion
- 2025-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |