drugset / Trial / NCT04578613
ICP-022 Versus Chlorambucil Combined With Rituximab in the Treatment of Untreated CLL/SLL
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, multicenter, open-label, Phase 3 study to evaluate the efficacy and safety of ICP-022 versus Chlorambucil plus Rituximab in subjects with Previously Untreated Chronic Lymphocytic Leukemia.
Timeline
- Start
- 2021-01-08
- Primary completion
- 2024-12-30
- Completion
- 2025-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Chlorambucil | Other / unclassified | 0.5 mg/kg | Oral |
| Subject | Orelabrutinib | Small molecule | 150 mg | Oral |
| Comparator | Rituximab | Monoclonal antibody | 500 mg/m2 | Intravenous |