ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03)
NCT ID: NCT06378138
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
226 participants
INTERVENTIONAL
2024-05-15
2031-07-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ICP-248 in combination with Orelabrutinib
ICP-248
Eligible patients will receive ICP-248 orally as per the protocol，once daily for every 28 days as one treatment cycle
Orelabrutinib
Eligible patients will receive Orelabrutinib orally as per the protocol，once daily for every 28 days as one treatment cycle
Interventions
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ICP-248
Eligible patients will receive ICP-248 orally as per the protocol，once daily for every 28 days as one treatment cycle
Orelabrutinib
Eligible patients will receive Orelabrutinib orally as per the protocol，once daily for every 28 days as one treatment cycle
Eligibility Criteria
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Inclusion Criteria
2. CLL/SLL is diagnosed by histopathology and/or flow cytometry according to the 2016 World Health Organization (WHO) classification criteria for lymphohematopoietic neoplasms or meeting the criteria of 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL 2018):
3. Having an indication for treatment that meets the criteria for iwCLL 2018
4. Subjects must have measurable lesion according to the Lugano 2014 Assessment Criteria.
5. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2 and a life expectancy of ≥ 6 months.
6. Adequate hematologic function
7. Patients with basically normal coagulation function
8. Patients with adequate hepatic, renal, pulmonary and cardiac functions
9. Subjects are able to communicate with the investigator well and to complete the study as specified in the study.
10. Before the trial, the subjects shall understand the nature, significance, possible benefits, inconveniences and potential risks, as well as the study procedures of the trial in detail and voluntarily sign the written Informed Consent Form (ICF).
Exclusion Criteria
2. Concomitant Richter transformation.
3. Prior systemic treatment, excluding emergency pretreatment to reduce white blood cells and relieve leukostasis.
4. Requireing continuous glucocorticoid support or glucocorticoid therapy within 5 days.
5. History of allogeneic stem cell transplantation.
6. Major organ surgery (excluding aspiration biopsy) or significant trauma within 28 days prior to the first dose of the investigational drug or require elective surgery during the trial.
7. Presence of active infection that requires intravenous anti-infective therapy.
8. Hepatitis B or C virus infection.
9. History of immunodeficiency disease or Significant cardiovascular disease
10. Central nervous system disorders or Severe bleeding disorder
11. Alcohol or drug dependence.
12. Mental disorders or poor compliance.
18 Years
80 Years
ALL
No
Sponsors
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Beijing InnoCare Pharma Tech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Anhui Provincial Hospital (The First Affiliated Hospital of University of Science and Technology of China)
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical University
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Gansu Provincial People's Hospital
Lanzhou, Gansu, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Guangdong General Hospital
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Affiliated Hospital of North China University of Science and Technology
Tangshan, Hebei, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Nanyang City Center Hospital
Nanyang, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Henan Cancer Hospital
Zhenzhou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
The Second Xiangya Hospital, Central South University
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Changzhou First People's Hospital
Changzhou, Jiangsu, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Bethune First Hospital of Jilin University
Changchun, Jilin, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
Shandong Cancer Hospital
Jinan, Shandong, China
Jining First People's Hospital
Jining, Shandong, China
Linyi City Cancer Hospital
Linyi, Shandong, China
Huashan Hospital
Shanghai, Shanghai Municipality, China
Shanghai Huashan Hospital
Shanghai, Shanghai Municipality, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Shaanxi Provincial People's Hospital
Xi’an, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Yibin Second People's Hospital
Yibin, Sichuan, China
Blood Diseases Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
The Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The People's Hospital Affiliated to Ningbo University
Ningbo, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Yanli Yang
Role: primary
Xingbing Wang
Role: primary
Jian Ge
Role: primary
Hongmei Jing
Role: primary
Xiaoqiong Tang
Role: primary
Xixi Xiang
Role: primary
Zhenshu Xu
Role: primary
Bing Xu
Role: primary
Qike Zhang
Role: primary
Yang Liang
Role: primary
Wenyu Li
Role: primary
Xutao Guo
Role: primary
Jun Luo
Role: primary
Mingqiang Ren
Role: primary
Lihong Liu
Role: primary
Zhenyu 063000 Yan
Role: primary
Ling Qin
Role: primary
Chao Li
Role: primary
Zunmin Zhu
Role: primary
Keshu Zhou
Role: primary
Xiaoxi Zhou
Role: primary
Guohui Cui
Role: primary
Huili Cai
Role: primary
Hongling Peng
Role: primary
Fang Zhou
Role: primary
Weiying Gu
Role: primary
Chunling Wang
Role: primary
Wei Xu
Role: primary
Fei Li
Role: primary
Ou Bai
Role: primary
Xiuhua Sun
Role: primary
Aijun Liao
Role: primary
Ming Hou
Role: primary
Xiaosheng Fang
Role: primary
Ji Ma
Role: primary
Tongfeng Zhao
Role: primary
Meifang Zheng
Role: primary
Yan Yuan
Role: primary
Yan Yuan
Role: primary
Zhuanzhen Zheng
Role: primary
Liping Su
Role: primary
Jianli Wang
Role: primary
Yi Wang
Role: primary
Kai Shen
Role: primary
Xiaobing Huang
Role: primary
Shihua Huang
Role: primary
Tingyu Wang
Role: primary
Xingli Zhao
Role: primary
Lihua Qiu
Role: primary
Shujuan Wen
Role: primary
Mingxia Shi
Role: primary
Wenjuan Yu
Role: primary
Ying Lu
Role: primary
Other Identifiers
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ICP-CL-01203
Identifier Type: -
Identifier Source: org_study_id
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