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

Phase 3

Recruiting

• Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
• Interventions: Drug: Chlorambucil; Drug: ICP-022; Drug: Rituximab

• Registration Number: NCT04578613
• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-01
• Study First Submitted QC: 2020-10-01
• Study First Posted: 2020-10-08
• Study Start: 2021-01-08
• Status Verified: 2023-05
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-05
• Primary Completion: 2024-12-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

1. 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)
2. 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
3. ECOG physical strength score is 0-2.
4. Expected survival time >6 months.
5. Voluntary written informed consent prior to screening.

Key

Exclusion Criteria

1. Patients with stroke or intracranial hemorrhage in the first 6 months were randomly assigned.
2. Hypersensitivity to ICP-022, nitrogen mustard benzoate, rituximab or any other component of the applicable study drug.
3. Any mental or cognitive impairment that may limit their understanding of the informed consent, their implementation and their compliance with the study.
4. 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.
5. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorambucil combined with Rituximab	Chlorambucil	Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles.
Chlorambucil combined with Rituximab	Rituximab	Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles.
ICP-022	ICP-022	ICP-022 will be orally administered until disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	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).

Secondary Outcome Measures

Name	Time	Method
Duration Of Response (DOR)	Up to 5 years
Overall Survival (OS)	Up to 5 years
Objective Response Rate (ORR)	Up to 5 years

Trial Locations

Locations (56)

The First Affiliated Hospital of Bengbu Medical College; 🇨🇳 Bengbu, Anhui, China

Anhui Provincial Cancer Hospital; 🇨🇳 Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

The Fifth Medical Center of PLA General Hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Congqing Medical University; 🇨🇳 Chongqing, Chongqing, China

The Second Affiliated Hospital of Army Medical University; 🇨🇳 Chongqing, Chongqing, China

The First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China

Lanzhou University Second Hospital; 🇨🇳 Lanzhou, Gansu, China

Dongguan People's Hospital; 🇨🇳 Dongguan, Guangdong, China

Cancer Prevention and Treatment Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

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