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

Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Study ID
NCT04578613
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ICP-022 — DRUG
    ICP-022 at a dose of 150mg, QD
  • Chlorambucil — DRUG
    0.5 mg/kg body weight orally on Day 1 and Day 15 of Cycles 1-6
  • Rituximab — DRUG
    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)

Study Details

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.

Key Dates

Start date
Jan 8, 2021
Status verified
May 2023
Primary completion
Dec 30, 2024
Completion
Jun 30, 2025

Study Design

Enrollment
218 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ICP-022
    ICP-022 will be orally administered until disease progression or unacceptable toxicity.
  • Active Comparator: Chlorambucil combined with Rituximab
    Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]

Central Contacts

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