nctId: NCT06378138 id: ICP-CL-01203 briefTitle: ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2030-11-25 date: 2031-07-25 date: 2024-04-22 date: 2024-04-22 name: Beijing InnoCare Pharma Tech Co., Ltd. class: INDUSTRY briefSummary: Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma conditions: Hematologic Malignancies studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 226 type: ESTIMATED name: ICP-248 name: Orelabrutinib measure: Adverse events (AEs) and serious adverse events (SAEs) evaluation according to CTCAE V5.0 or iwCLL 2018 criteria measure: Changes from baseline in pulse. measure: Changes from baseline in blood pressure. measure: Changes from baseline in ECG QRS interval. measure: Changes from baseline in ECG QT interval. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Anhui Medical University city: Hefei state: Anhui zip: 230022 country: China name: Jian Ge role: CONTACT lat: 31.86389 lon: 117.28083 facility: Peking University Third Hospital city: Beijing state: Beijing zip: 100191 country: China name: Hongmei Jing role: CONTACT lat: 39.9075 lon: 116.39723 facility: The First Affiliated Hospital of Chongqing Medical University city: Chongqing state: Chongqing zip: 400016 country: China name: Xiaoqiong Tang role: CONTACT lat: 29.56278 lon: 106.55278 facility: Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical University city: Chongqing state: Chongqing zip: 400037 country: China name: Xixi Xiang role: CONTACT lat: 29.56278 lon: 106.55278 facility: Fujian Medical University Union Hospital city: Fuzhou state: Fujian zip: 350001 country: China name: Zhenshu Xu role: CONTACT lat: 26.06139 lon: 119.30611 facility: The First Affiliated Hospital of Xiamen University city: Xiamen state: Fujian zip: 361003 country: China name: Bing Xu role: CONTACT lat: 24.47979 lon: 118.08187 facility: Sun Yat-sen University Cancer Center city: Guangzhou state: Guangdong zip: 510055 country: China name: Yang Liang role: CONTACT lat: 23.11667 lon: 113.25 facility: The Fourth Hospital of Hebei Medical University city: Shijiazhuang state: Hebei zip: 050010 country: China name: Lihong Liu role: CONTACT lat: 38.04139 lon: 114.47861 facility: Nanyang City Center Hospital city: Nanyang state: Henan zip: 473005 country: China name: Chao Li role: CONTACT lat: 32.99472 lon: 112.53278 facility: Henan Provincial People's Hospital city: Zhengzhou state: Henan zip: 463599 country: China name: Zunmin Zhu role: CONTACT lat: 34.75778 lon: 113.64861 facility: Henan Cancer Hospital city: Zhenzhou state: Henan zip: 450003 country: China name: Keshu Zhou role: CONTACT lat: 32.28034 lon: 119.16999 facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430011 country: China name: Xiaoxi Zhou role: CONTACT lat: 30.58333 lon: 114.26667 facility: Union Hospital Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430022 country: China name: Guohui Cui role: CONTACT lat: 30.58333 lon: 114.26667 facility: The Second Xiangya Hospital, Central South University city: Changsha state: Hunan zip: 410012 country: China name: Hongling Peng role: CONTACT lat: 28.19874 lon: 112.97087 facility: Hunan Cancer Hospital city: Changsha state: Hunan zip: 410031 country: China name: Fang Zhou role: CONTACT lat: 28.19874 lon: 112.97087 facility: Jiangsu Province Hospital city: Nanjing state: Jiangsu zip: 210029 country: China name: Wei Xu role: CONTACT lat: 32.06167 lon: 118.77778 facility: The First Affiliated Hospital of Nanchang University city: Nanchang state: Jiangxi zip: 330006 country: China name: Fei Li role: CONTACT lat: 28.68396 lon: 115.85306 facility: Bethune First Hospital of Jilin University city: Changchun state: Jilin zip: 130061 country: China name: Ou Bai role: CONTACT lat: 43.88 lon: 125.32278 facility: The Second Hospital of Dalian Medical University city: Dalian state: Liaoning zip: 116023 country: China name: Xiuhua Sun role: CONTACT lat: 38.91222 lon: 121.60222 facility: Shengjing Hospital affiliated to China Medical University city: Shenyang state: Liaoning zip: Liaoning country: China name: Aijun Liao role: CONTACT lat: 41.79222 lon: 123.43278 facility: Shandong Cancer Hospital city: Jinan state: Shandong zip: 250117 country: China name: Ji Ma role: CONTACT lat: 36.66833 lon: 116.99722 facility: Linyi City Cancer Hospital city: Linyi state: Shandong zip: 276002 country: China name: Meifang Zheng role: CONTACT lat: 35.06306 lon: 118.34278 facility: Huashan Hospital city: Shanghai state: Shanghai zip: 200040 country: China name: Tong Chen role: CONTACT lat: 31.22222 lon: 121.45806 facility: The Second Affiliated Hospital of Xi'an Jiaotong University city: Xi'an state: Shanxi zip: 710004 country: China name: Jianli Wang role: CONTACT lat: 34.25833 lon: 108.92861 facility: Sichuan Provincial People's Hospital city: Chengdu state: Sichuan zip: 610072 country: China name: Xiaobing Huang role: CONTACT lat: 30.66667 lon: 104.06667 facility: Yibin Second People's Hospital city: Yibin state: Sichuan zip: 644002 country: China name: Shihua Huang role: CONTACT lat: 28.76667 lon: 104.62383 facility: Tianjin Medical University Cancer Institute and Hospital city: Tianjin state: Tianjin zip: 300181 country: China name: Lihua Qiu role: CONTACT lat: 39.14222 lon: 117.17667 facility: The Affiliated Cancer Hospital of Xinjiang Medical University city: Urumqi state: Xinjiang Uygur Autonomous Region zip: 830000 country: China name: Shujuan Wen role: CONTACT lat: 43.80096 lon: 87.60046 facility: The First Affiliated Hospital of Kunming Medical University city: Kunming state: Yunnan zip: 650032 country: China name: Mingxia Shi role: CONTACT lat: 25.03889 lon: 102.71833 facility: The First Affiliated Hospital of Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310003 country: China name: Wenjuan Yu role: CONTACT lat: 30.29365 lon: 120.16142 hasResults: False