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