ICP-022 Versus Chlorambucil Combined With Rituximab in the Treatment of Untreated CLL/SLL
- Conditions
- Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
- Interventions
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 218
- 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 0-2.
- Expected survival time >6 months.
- Voluntary written informed consent prior to screening.
Key
- 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.
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 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
The Fifth Medical Center of PLA General Hospital
🇨🇳Beijing, Beijing, 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
Shenzhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
Affiliated Hospital of Guilin Medical College
🇨🇳Guilin, Guangxi Zhuang Autonomous Region, China
Hebei Medical University Second Hospital
🇨🇳Shijiazhuang, Hebei, China
Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Affiliated Tumor Hospital of Harbin Medical University
🇨🇳Ha'erbin, Heilongjiang, China
The first Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Henan Province Hospital
🇨🇳Zhengzhou, Henan, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Zhuzhou Central Hospital
🇨🇳Zhuzhou, Hunan, China
Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Subei People's Hospital
🇨🇳Yangzhou, Jiangsu, China
The First Affiliated Hospital of Gannan Medical College
🇨🇳Ganzhou, Jiangxi, China
Zhongnan Hospital of WuHan University
🇨🇳Wuhan, Hubei, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University
🇨🇳Dalian, Liaoning, China
Affiliated Hospital of Binzhou Medical College
🇨🇳Binzhou, Shandong, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
The Second Affiliated Hospital of Xi´an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Yibin Second People's Hospital
🇨🇳Yibin, Sichuan, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Ürümqi, Xinjiang Uygur Autonomous Region, China
The First Affiliated Hospital of Zhejiang University Medical College
🇨🇳Hangzhou, Zhejiang, China
Affiliated Hospital of Hebei University
🇨🇳Baoding, Hebei, China
First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Yichang First People's Hospital
🇨🇳Yichang, Hubei, China
Yichang Central People's Hospital
🇨🇳Yichang, Hubei, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
Jiangxi Cancer Hospital
🇨🇳Nanchang, Jiangxi, China
The First Affiliated Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Shandong Cancer Hospita
🇨🇳Jinan, Shandong, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, 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 Kunming Medical University
🇨🇳Kunming, Yunnan, China
Dongyang People's Hospital
🇨🇳Dongyang, Zhejiang, China
Shaoyifu Hospital Affiliated to Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Jinhua Central Hospital
🇨🇳Jinhua, Zhejiang, China
Ningbo First Hospital
🇨🇳Ningbo, Zhejiang, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China