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Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICP-248 in combination with Orelabrutinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICP-248 | Drug | Eligible patients will receive ICP-248 orally as per the protocol,once daily for every 28 days as one treatment cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) and serious adverse events (SAEs) evaluation according to CTCAE V5.0 or iwCLL 2018 criteria | Up to 6 years | |
| Changes from baseline in pulse. | Up to 6 years | |
| Changes from baseline in blood pressure. | Up to 6 years | |
| Changes from baseline in ECG QRS interval. | Up to 6 years | |
| Changes from baseline in ECG QT interval. | Up to 6 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexia Lu | Contact | 010-66609745 | CO_HGRAC@innocarepharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Recruiting | Bengbu | Anhui | 233004 | China |
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| Orelabrutinib | Drug | Eligible patients will receive Orelabrutinib orally as per the protocol,once daily for every 28 days as one treatment cycle |
|
| Anhui Provincial Hospital (The First Affiliated Hospital of University of Science and Technology of China) | Recruiting | Hefei | Anhui | 230001 | China |
|
| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | 230022 | China |
|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
|
| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400016 | China |
|
| Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical University | Recruiting | Chongqing | Chongqing Municipality | 400037 | China |
|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
|
| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | Fujian | 361003 | China |
|
| Gansu Provincial People's Hospital | Recruiting | Lanzhou | Gansu | 730000 | China |
|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510055 | China |
|
| Guangdong General Hospital | Not yet recruiting | Guangzhou | Guangdong | 510080 | China |
|
| Nanfang Hospital of Southern Medical University | Not yet recruiting | Guangzhou | Guangdong | 510515 | China |
|
| The First Affiliated Hospital of Guangxi Medical University | Not yet recruiting | Nanning | Guangxi | 530021 | China |
|
| The Affiliated Hospital of Zunyi Medical University | Not yet recruiting | Zunyi | Guizhou | 563003 | China |
|
| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050010 | China |
|
| The Affiliated Hospital of North China University of Science and Technology | Recruiting | Tangshan | Hebei | 063000 | China |
|
| The First Affiliated Hospital of Henan University of Science and Technology | Recruiting | Luoyang | Henan | 471003 | China |
|
| Nanyang City Center Hospital | Recruiting | Nanyang | Henan | 473005 | China |
|
| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | 463599 | China |
|
| Henan Cancer Hospital | Recruiting | Zhenzhou | Henan | 450003 | China |
|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430011 | China |
|
| Union Hospital Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430022 | China |
|
| Yichang Central People's Hospital | Recruiting | Yichang | Hubei | 443003 | China |
|
| The Second Xiangya Hospital, Central South University | Recruiting | Changsha | Hunan | 410012 | China |
|
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410031 | China |
|
| Changzhou First People's Hospital | Not yet recruiting | Changzhou | Jiangsu | 213003 | China |
|
| Huai'an First People's Hospital | Recruiting | Huai'an | Jiangsu | 223300 | China |
|
| Jiangsu Province Hospital | Recruiting | Nanjing | Jiangsu | 210029 | China |
|
| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
|
| Bethune First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130061 | China |
|
| The Second Hospital of Dalian Medical University | Recruiting | Dalian | Liaoning | 116023 | China |
|
| Shengjing Hospital affiliated to China Medical University | Recruiting | Shenyang | Liaoning | Liaoning | China |
|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
|
| Shandong Provincial Hospital | Recruiting | Jinan | Shandong | 250021 | China |
|
| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250117 | China |
|
| Jining First People's Hospital | Recruiting | Jining | Shandong | 272011 | China |
|
| Linyi City Cancer Hospital | Recruiting | Linyi | Shandong | 276002 | China |
|
| Huashan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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| Shanghai Huashan Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 201108 | China |
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| The Second Hospital of Shanxi Medical University | Not yet recruiting | Taiyuan | Shanxi | 030001 | China |
|
| Shanxi Cancer Hospital | Not yet recruiting | Taiyuan | Shanxi | 030013 | China |
|
| The Second Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi’an | Shanxi | 710004 | China |
|
| Shaanxi Provincial People's Hospital | Recruiting | Xi’an | Shanxi | 710068 | China |
|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
|
| Sichuan Provincial People's Hospital | Recruiting | Chengdu | Sichuan | 610072 | China |
|
| Yibin Second People's Hospital | Recruiting | Yibin | Sichuan | 644002 | China |
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| Blood Diseases Hospital of Chinese Academy of Medical Sciences | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
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| Tianjin People's Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300120 | China |
|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300181 | China |
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| The Affiliated Cancer Hospital of Xinjiang Medical University | Recruiting | Ürümqi | Xinjiang Uygur Autonomous Region | 830000 | China |
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| The First Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | 650032 | China |
|
| The First Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310003 | China |
|
| The People's Hospital Affiliated to Ningbo University | Recruiting | Ningbo | Zhejiang | 315040 | China |
|
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000729508 | orelabrutinib |
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