drugset / Trial / NCT04075292
Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, multicenter, open-label, Phase 3 study to evaluate the efficacy and safety of Acalabrutinib versus Chlorambucil plus Rituximab in subjects with Previously Untreated Chronic Lymphocytic Leukemia.
Timeline
- Start
- 2020-01-20
- Primary completion
- 2024-01-03
- Completion
- 2027-01-01
Outcome
Met primary endpoint
registry analysis (superiority test); Acalabrutinib vs Chlorambucil Plus Rituximab; p <0.0001; Hazard Ratio (HR) 0.08 (95% CI 0.03 to 0.18); Log Rank NCT04075292 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acalabrutinib | Small molecule | 100 mg | Oral |
| Comparator | Chlorambucil | Other / unclassified | 0.5 mg/kg | Oral |
| Comparator | Rituximab | Monoclonal antibody | 500 mg/m2 | Intravenous |