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)

Beijing InnoCare Pharma Tech Co., Ltd.56 sites in 1 country218 target enrollmentJanuary 8, 2021

ConditionsChronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

InterventionsICP-022 Chlorambucil Rituximab

DrugsICP-022 Chlorambucil Rituximab

Overview

Phase: Phase 3
Intervention: ICP-022
Conditions: Chronic Lymphocytic Leukemia
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Enrollment: 218
Locations: 56
Primary Endpoint: Progression Free Survival (PFS)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 8, 2021

End Date

June 30, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female, age ≥65 years old or age \>18 years old or \<65 years old, age \>18 years old or \<65 years old shall meet any of the following criteria simultaneously: A.Disease accumulation score (CIRS) \> 6;B. Creatinine clearance at 30-69 mL/ min (Cockcroft-Gault assessment)
•Enhanced computed tomography/magnetic resonance imaging (CT/MRI) detection had measurable lesions: at least one lymph node had a maximum axis of more than 1.5 cm and had a measurable vertical dimension
•ECOG physical strength score is 0-
•Expected survival time \>6 months.
•Voluntary written informed consent prior to screening.

Exclusion Criteria

•Patients with stroke or intracranial hemorrhage in the first 6 months were randomly assigned.
•Hypersensitivity to ICP-022, nitrogen mustard benzoate, rituximab or any other component of the applicable study drug.
•Any mental or cognitive impairment that may limit their understanding of the informed consent, their implementation and their compliance with the study.
•Pregnant and lactating women, or subjects of childbearing age who do not want to use contraception within 180 days from the end of the study period to the end of the study period.
•Conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator.
•Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Arms & Interventions

ICP-022

ICP-022 will be orally administered until disease progression or unacceptable toxicity.

Intervention: ICP-022

Chlorambucil combined with Rituximab

Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles.

Intervention: Chlorambucil

Chlorambucil combined with Rituximab

Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles.

Intervention: Rituximab

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

Time Frame: Up to 5 years

Progress-free survival (PFS) was evaluated by the independent review board (IRC) against the IWCLL2018 criteria (Hallek et al., 2018) and the revised lymphoma mitigation assessment criteria (Cheson et al., 2014).