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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICP-022 | Experimental | ICP-022 will be orally administered until disease progression or unacceptable toxicity. |
|
| Chlorambucil combined with Rituximab | Active Comparator | Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICP-022 | Drug | ICP-022 at a dose of 150mg, QD |
| |
| Chlorambucil |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Up to 5 years | |
| Duration Of Response (DOR) | Up to 5 years | |
| Overall Survival (OS) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| April Huang | Contact | 010-66609723 | April.huang@innocarepharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Not yet recruiting | Bengbu | Anhui | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42402625 | Derived | Li F, Zhou K, Xu W, Cui G, Yi S, Jin J, Zhu Z, He A, Mi J, Xia Z, Huang X, Zhou X, Yu W, Guo J, Zeng Q, Huang S, Shuang Y, Peng H, Qiu L, Xu B, Li Y, Yang Y, Zhou F, Wang Y, Liu L, Ren J, Li Y, Yang W, Gu J, Ouyang G, Hua L, Zhang J, Xiao Q, Wang S, Zhang Q, Liu J, Ding K, Zhang L, Zeng Y, Li Z, Wen Q, Gao K, Yang H, Jiang Y, Chen Y, Li Z, Tang X, Wang W, Zhao R, Qiu L, Li J. Orelabrutinib versus chemoimmunotherapy in treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma: a randomized, phase 3 trial. Signal Transduct Target Ther. 2026 Jul 6;11(1):261. doi: 10.1038/s41392-026-02818-x. |
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| Drug |
0.5 mg/kg body weight orally on Day 1 and Day 15 of Cycles 1-6 |
|
| Rituximab | Drug | 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) |
|
| Up to 5 years |
| Anhui Provincial Cancer Hospital | Not yet recruiting | Hefei | Anhui | China |
|
| The First Affiliated Hospital of Anhui Medical University | Not yet recruiting | Hefei | Anhui | China |
|
| The Fifth Medical Center of PLA General Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
|
| The First Affiliated Hospital of Congqing Medical University | Not yet recruiting | Chongqing | Chongqing Municipality | 400000 | China |
|
| The Second Affiliated Hospital of Army Medical University | Not yet recruiting | Chongqing | Chongqing Municipality | China |
|
| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | Fujian | China |
|
| Lanzhou University Second Hospital | Not yet recruiting | Lanzhou | Gansu | China |
|
| Dongguan People's Hospital | Not yet recruiting | Dongguan | Guangdong | 523058 | China |
|
| Cancer Prevention and Treatment Center, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
|
| Guangzhou First People's Hospital | Recruiting | Guangzhou | Guangdong | China |
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| Shenzhen People's Hospital | Not yet recruiting | Shenzhen | Guangdong | China |
|
| Affiliated Hospital of Guilin Medical College | Not yet recruiting | Guilin | Guangxi | 541000 | China |
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| Affiliated Hospital of Hebei University | Not yet recruiting | Baoding | Hebei | China |
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| Hebei Medical University Second Hospital | Recruiting | Shijiazhuang | Hebei | h | China |
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| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | China |
|
| Affiliated Tumor Hospital of Harbin Medical University | Not yet recruiting | Harbin | Heilongjiang | China |
|
| The first Affiliated Hospital of Henan University of Science and Technology | Not yet recruiting | Luoyang | Henan | China |
|
| First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | China |
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| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | China |
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| Henan Province Hospital | Recruiting | Zhengzhou | Henan | China |
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| Zhongnan Hospital of WuHan University | Not yet recruiting | Wuhan | Hubei | 430071 | China |
|
| Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
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| Yichang Central People's Hospital | Recruiting | Yichang | Hubei | China |
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| Yichang First People's Hospital | Recruiting | Yichang | Hubei | China |
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| The Second Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | 410000 | China |
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| The Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
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| Zhuzhou Central Hospital | Not yet recruiting | Zhuzhou | Hunan | 412007 | China |
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| Jiangsu Province Hospital | Recruiting | Nanjing | Jiangsu | China |
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| The First Affiliated Hospital of Soochow University | Not yet recruiting | Suzhou | Jiangsu | China |
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| Wuxi People's Hospital | Not yet recruiting | Wuxi | Jiangsu | China |
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| Affiliated Hospital of Xuzhou Medical University | Not yet recruiting | Xuzhou | Jiangsu | China |
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| Subei People's Hospital | Not yet recruiting | Yangzhou | Jiangsu | China |
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| The First Affiliated Hospital of Gannan Medical College | Not yet recruiting | Ganzhou | Jiangxi | 341004 | China |
|
| Jiangxi Cancer Hospital | Recruiting | Nanchang | Jiangxi | China |
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| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | China |
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| Shengjing Hospital of China Medical University | Recruiting | Dalian | Liaoning | China |
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| The First Affiliated Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | China |
|
| Affiliated Hospital of Binzhou Medical College | Recruiting | Binzhou | Shandong | China |
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| Shandong Cancer Hospita | Not yet recruiting | Jinan | Shandong | 250117 | China |
|
| Shandong Provincial Hospital | Recruiting | Jinan | Shandong | China |
|
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | 200025 | China |
|
| The Second Affiliated Hospital of Xi´an Jiaotong University | Not yet recruiting | Xi’an | Shanxi | 710000 | China |
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| Sichuan Provincial People's Hospital | Recruiting | Chengdu | Sichuan | China |
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| West China Hospital of Sichuan University | Not yet recruiting | Chengdu | Sichuan | China |
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| Yibin Second People's Hospital | Recruiting | Yibin | Sichuan | China |
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| General Hospital of Tianjin Medical University | Recruiting | Tianjin | Tianjin Municipality | China |
|
| Hospital of Hematology, Chinese Academy of Medical Sciences | Recruiting | Tianjin | Tianjin Municipality | China |
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| Tianjin Cancer Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
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| The First Affiliated Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang Uygur Autonomous Region | 830011 | China |
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| The first Affiliated Hospital of Kunming Medical University | Not yet recruiting | Kunming | Yunnan | China |
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| Dongyang People's Hospital | Not yet recruiting | Dongyang | Zhejiang | 322199 | China |
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| Shaoyifu Hospital Affiliated to Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 310026 | China |
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| The First Affiliated Hospital of Zhejiang University Medical College | Recruiting | Hangzhou | Zhejiang | China |
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| Jinhua Central Hospital | Not yet recruiting | Jinhua | Zhejiang | 321000 | China |
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| Ningbo First Hospital | Not yet recruiting | Ningbo | Zhejiang | China |
|
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002699 | Chlorambucil |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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