NCT04578613

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

A Randomized, Controlled, Open, Multicenter Phase 3 Study to Evaluate ICP-022 Versus Chlorambucil Combined With Rituximab for Primary Treatment of Chronic Lymphocytic Leukemia(CLL)/ Small Lymphocytic Lymphoma(SLL)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 218 (estimated)
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
DRUG	ICP-022	ICP-022 at a dose of 150mg, QD
DRUG	Chlorambucil	0.5 mg/kg body weight orally on Day 1 and Day 15 of Cycles 1-6
DRUG	Rituximab	375 mg/m2 IV infusion on Day 1 of Cycle 1. 500 mg/m2 IV infusion on Day 1 for each of subsequent cycles (Cycles 2-6)

Timeline

• Start date: 2021-01-08
• Primary completion: 2024-12-30
• Completion: 2025-06-30
• First posted: 2020-10-08
• Last updated: 2023-06-05

Locations

56 sites across 1 country: China