ICP-022 Versus Chlorambucil Combined With Rituximab in the Treatment of Untreated CLL/SLL
NCT ID: NCT04578613
Last Updated: 2023-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
218 participants
INTERVENTIONAL
2021-01-08
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ICP-022
ICP-022 will be orally administered until disease progression or unacceptable toxicity.
ICP-022
ICP-022 at a dose of 150mg, QD
Chlorambucil combined with Rituximab
Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles.
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Beijing InnoCare Pharma Tech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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 Municipality, China
The First Affiliated Hospital of Congqing Medical University
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Army Medical University
Chongqing, Chongqing Municipality, 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
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Affiliated Hospital of Guilin Medical College
Guilin, Guangxi, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
Hebei Medical University Second Hospital
Shijiazhuang, Hebei, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Affiliated Tumor Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The first Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Henan Province Hospital
Zhengzhou, Henan, China
Zhongnan Hospital of WuHan University
Wuhan, Hubei, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
Yichang First People's Hospital
Yichang, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Zhuzhou Central Hospital
Zhuzhou, 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
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
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University
Dalian, Liaoning, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Affiliated Hospital of Binzhou Medical College
Binzhou, Shandong, China
Shandong Cancer Hospita
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of Xi´an Jiaotong University
Xi’an, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Yibin Second People's Hospital
Yibin, Sichuan, China
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Hospital of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region, 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
The First Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, China
Jinhua Central Hospital
Jinhua, Zhejiang, China
Ningbo First Hospital
Ningbo, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Yanli Yang
Role: primary
Kaiyang Ding
Role: primary
Qingshu Zeng
Role: primary
Hang Su
Role: primary
Qing Xiao
Role: primary
Qin Wen
Role: primary
Bing Xu
Role: primary
Liansheng Zhang
Role: primary
Yirong Jiang
Role: primary
Zhongjun Xia
Role: primary
Qingshun Wang
Role: primary
Xinyou Zhang
Role: primary
Wenyuan Lin
Role: primary
Luoming Hua
Role: primary
Jinhai Ren
Role: primary
Lihong Liu
Role: primary
Qingyuan Zhang
Role: primary
Haiping Yang
Role: primary
Mingzhi Zhang
Role: primary
Keshu Zhou
Role: primary
Zunmin Zhu
Role: primary
Fuling Zhou
Role: primary
Guohui Cui
Role: primary
Jingming Guo
Role: primary
Kaibo Gao
Role: primary
Hongling Peng
Role: primary
Jing Liu
Role: primary
Guoyu Hu
Role: primary
Jianyong Li
Role: primary
Wei Xu
Role: backup
Zhengming Jing
Role: primary
Xin Zhou
Role: primary
Zhenyu Li
Role: primary
Jian Gu
Role: primary
Yijian Chen
Role: primary
Yuerong Shuang
Role: primary
Fei Li
Role: primary
Wei Yang
Role: primary
Yan Li
Role: primary
Wenzheng Yu
Role: primary
Zengjun Li
Role: primary
Xin Wang
Role: primary
Jianqing Mi
Role: primary
Aili, He
Role: primary
Xiaobing Huang
Role: primary
Ting Niu
Role: primary
Shihua Huang
Role: primary
Rong Fu
Role: primary
Lugui Qiu
Role: primary
Shuhua Yi
Role: backup
Lihua Qiu
Role: primary
Yafei Wang
Role: backup
Jianhua Qu
Role: primary
Yun Zeng
Role: primary
Gongqiang Wu
Role: primary
Jin Zhang
Role: primary
Jie Jin
Role: primary
Huixian Hu
Role: primary
Guifang Ouyang
Role: primary
Other Identifiers
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ICP-CL-00111
Identifier Type: -
Identifier Source: org_study_id
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