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)
Who is this study for? Adult patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
What treatments are being studied? ICP-022
Status: Unknown
Location: See all (56) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Affiliated Hospital of Hebei University
NOT_YET_RECRUITING
Baoding
The Fifth Medical Center of PLA General Hospital
NOT_YET_RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical College
NOT_YET_RECRUITING
Bengbu
Affiliated Hospital of Binzhou Medical College
RECRUITING
Binzhou
The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
The Third Xiangya Hospital of Central South University
RECRUITING
Changsha
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
The First Affiliated Hospital of Congqing Medical University
NOT_YET_RECRUITING
Chongqing
The Second Affiliated Hospital of Army Medical University
NOT_YET_RECRUITING
Chongqing
Shengjing Hospital of China Medical University
RECRUITING
Dalian
Dongguan People's Hospital
NOT_YET_RECRUITING
Dongguan
Dongyang People's Hospital
NOT_YET_RECRUITING
Dongyang
The First Affiliated Hospital of Gannan Medical College
NOT_YET_RECRUITING
Ganzhou
Cancer Prevention and Treatment Center, Sun Yat-sen University
RECRUITING
Guangzhou
Guangzhou First People's Hospital
RECRUITING
Guangzhou
Affiliated Hospital of Guilin Medical College
NOT_YET_RECRUITING
Guilin
Shaoyifu Hospital Affiliated to Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital of Zhejiang University Medical College
RECRUITING
Hangzhou
Affiliated Tumor Hospital of Harbin Medical University
NOT_YET_RECRUITING
Harbin
Anhui Provincial Cancer Hospital
NOT_YET_RECRUITING
Hefei
The First Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITING
Hefei
Shandong Cancer Hospita
NOT_YET_RECRUITING
Jinan
Shandong Provincial Hospital
RECRUITING
Jinan
Jinhua Central Hospital
NOT_YET_RECRUITING
Jinhua
The first Affiliated Hospital of Kunming Medical University
NOT_YET_RECRUITING
Kunming
Lanzhou University Second Hospital
NOT_YET_RECRUITING
Lanzhou
The first Affiliated Hospital of Henan University of Science and Technology
NOT_YET_RECRUITING
Luoyang
Jiangxi Cancer Hospital
RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Jiangsu Province Hospital
RECRUITING
Nanjing
Ningbo First Hospital
NOT_YET_RECRUITING
Ningbo
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
The First Affiliated Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Shenzhen People's Hospital
NOT_YET_RECRUITING
Shenzhen
Hebei Medical University Second Hospital
RECRUITING
Shijiazhuang
The Fourth Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
The First Affiliated Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
General Hospital of Tianjin Medical University
RECRUITING
Tianjin
Hospital of Hematology, Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Tianjin Cancer Hospital
RECRUITING
Tianjin
The First Affiliated Hospital of Xinjiang Medical University
NOT_YET_RECRUITING
Ürümqi
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
Wuhan
Zhongnan Hospital of WuHan University
NOT_YET_RECRUITING
Wuhan
Wuxi People's Hospital
NOT_YET_RECRUITING
Wuxi
The Second Affiliated Hospital of Xi´an Jiaotong University
NOT_YET_RECRUITING
Xi’an
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Affiliated Hospital of Xuzhou Medical University
NOT_YET_RECRUITING
Xuzhou
Subei People's Hospital
NOT_YET_RECRUITING
Yangzhou
Yibin Second People's Hospital
RECRUITING
Yibin
Yichang Central People's Hospital
RECRUITING
Yichang
Yichang First People's Hospital
RECRUITING
Yichang
First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Henan Cancer Hospital
RECRUITING
Zhengzhou
Henan Province Hospital
RECRUITING
Zhengzhou
Zhuzhou Central Hospital
NOT_YET_RECRUITING
Zhuzhou
Contact Information
Primary
April Huang
April.huang@innocarepharma.com
010-66609723
Time Frame
Start Date: 2021-01-08
Completion Date: 2025-06-30
Participants
Target number of participants: 218
Treatments
Experimental: ICP-022
ICP-022 will be orally administered until disease progression or unacceptable toxicity.
Active_comparator: Chlorambucil combined with Rituximab
Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles.
Related Therapeutic Areas
Sponsors
Leads: Beijing InnoCare Pharma Tech Co., Ltd.