drugset / Trial / NCT04578613

ICP-022 Versus Chlorambucil Combined With Rituximab in the Treatment of Untreated CLL/SLL

NCT04578613

Phase 3 Unknown 218 enrolled Beijing InnoCare Pharma Tech Co., Ltd.
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

EvaluationDrugModalityDoseRoute
Comparator Chlorambucil Other / unclassified 0.5 mg/kg Oral
Subject Orelabrutinib Small molecule 150 mg Oral
Comparator Rituximab Monoclonal antibody 500 mg/m2 Intravenous