ICP-248 in Combination with Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Registration Number
- NCT06378138
- Lead Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Brief Summary
Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 226
- Age ≥ 18 and ≤ 80 years.
- 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):
- Having an indication for treatment that meets the criteria for iwCLL 2018
- Subjects must have measurable lesion according to the Lugano 2014 Assessment Criteria.
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2 and a life expectancy of ≥ 6 months.
- Adequate hematologic function
- Patients with basically normal coagulation function
- Patients with adequate hepatic, renal, pulmonary and cardiac functions
- Subjects are able to communicate with the investigator well and to complete the study as specified in the study.
- 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).
- Central nervous system involvement.
- Concomitant Richter transformation.
- Prior systemic treatment, excluding emergency pretreatment to reduce white blood cells and relieve leukostasis.
- Requireing continuous glucocorticoid support or glucocorticoid therapy within 5 days.
- History of allogeneic stem cell transplantation.
- 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.
- Presence of active infection that requires intravenous anti-infective therapy.
- Hepatitis B or C virus infection.
- History of immunodeficiency disease or Significant cardiovascular disease
- Central nervous system disorders or Severe bleeding disorder
- Alcohol or drug dependence.
- Mental disorders or poor compliance.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ICP-248 in combination with Orelabrutinib ICP-248 - ICP-248 in combination with Orelabrutinib Orelabrutinib -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (50)
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
Gansu Provincial People's Hospital
🇨🇳Lanzhou, Gansu, 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 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
Yichang Central People's Hospital
🇨🇳Yichang, Hubei, China
Changzhou First People's Hospital
🇨🇳Changzhou, Jiangsu, China
Huai'an First People's Hospital
🇨🇳Huai'an, Jiangsu, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Jining First People's Hospital
🇨🇳Jining, Shandong, China
The Second Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Shanxi Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
Shaanxi Provincial People's Hospital
🇨🇳Xi'an, Shanxi, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Blood Diseases Hospital of Chinese Academy of Medical Sciences
🇨🇳Tianjin, Tianjin, China
The People's Hospital Affiliated to Ningbo University
🇨🇳Ningbo, Zhejiang, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, 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
The Second Xiangya Hospital, Central South University
🇨🇳Changsha, Hunan, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, 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
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
Linyi City Cancer Hospital
🇨🇳Linyi, Shandong, China
Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical University
🇨🇳Chongqing, Chongqing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Huashan Hospital
🇨🇳Shanghai, Shanghai, China
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
Yibin Second People's Hospital
🇨🇳Yibin, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
The Affiliated Cancer Hospital of Xinjiang Medical University
🇨🇳Urumqi, 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