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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04578613
• Other study ID #: ICP-CL-00111
• Status: Recruiting
• Phase: Phase 3
• Start date: January 8, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2023
• Source: Beijing InnoCare Pharma Tech Co., Ltd.
• Contact: April Huang
• Phone: 010-66609723
• Email: April.huang[@]innocarepharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 218
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Small Lymphocytic Lymphoma

Intervention

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

Locations

Country	Name	City	State
China	Affiliated Hospital of Hebei University	Baoding	Hebei
China	The Fifth Medical Center of PLA General Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Affiliated Hospital of Binzhou Medical College	Binzhou	Shandong
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Congqing Medical University	Chongqing	Chongqing
China	The Second Affiliated Hospital of Army Medical University	Chongqing	Chongqing
China	Shengjing Hospital of China Medical University	Dalian	Liaoning
China	Dongguan People's Hospital	Dongguan	Guangdong
China	Dongyang People's Hospital	Dongyang	Zhejiang
China	The First Affiliated Hospital of Gannan Medical College	Ganzhou	Jiangxi
China	Cancer Prevention and Treatment Center, Sun Yat-sen University	Guangzhou	Guangdong
China	Guangzhou First People's Hospital	Guangzhou	Guangdong
China	Affiliated Hospital of Guilin Medical College	Guilin	Guangxi Zhuang Autonomous Region
China	Affiliated Tumor Hospital of Harbin Medical University	Ha'erbin	Heilongjiang
China	Shaoyifu Hospital Affiliated to Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Zhejiang University Medical College	Hangzhou	Zhejiang
China	Anhui Provincial Cancer Hospital	Hefei	Anhui
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Shandong Cancer Hospita	Jinan	Shandong
China	Shandong Provincial Hospital	Jinan	Shandong
China	Jinhua Central Hospital	Jinhua	Zhejiang
China	The first Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	The first Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan
China	Jiangxi Cancer Hospital	Nanchang	Jiangxi
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Ningbo First Hospital	Ningbo	Zhejiang
China	Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	Hebei Medical University Second Hospital	Shijiazhuang	Hebei
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	General Hospital of Tianjin Medical University	Tianjin	Tianjin
China	Hospital of Hematology, Chinese Academy of Medical Sciences	Tianjin	Tianjin
China	Tianjin Cancer Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang Uygur Autonomous Region
China	Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	Zhongnan Hospital of WuHan University	Wuhan	Hubei
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	The Second Affiliated Hospital of Xi´an Jiaotong University	Xi'an	Shanxi
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Subei People's Hospital	Yangzhou	Jiangsu
China	Yibin Second People's Hospital	Yibin	Sichuan
China	Yichang Central People's Hospital	Yichang	Hubei
China	Yichang First People's Hospital	Yichang	Hubei
China	First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Henan Cancer Hospital	Zhengzhou	Henan
China	Henan Province Hospital	Zhengzhou	Henan
China	Zhuzhou Central Hospital	Zhuzhou	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing InnoCare Pharma Tech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	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).	Up to 5 years
Secondary	Objective Response Rate (ORR)		Up to 5 years
Secondary	Duration Of Response (DOR)		Up to 5 years
Secondary	Overall Survival (OS)		Up to 5 years