A Phase II/III Study of ICP-248 in Combination with Orelabrutinib in Patients with Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Status: Recruiting
Location: See all (50) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
China
Peking University Third Hospital
RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical College
NOT_YET_RECRUITING
Bengbu
Bethune First Hospital of Jilin University
RECRUITING
Changchun
Hunan Cancer Hospital
RECRUITING
Changsha
The Second Xiangya Hospital, Central South University
RECRUITING
Changsha
Changzhou First People's Hospital
NOT_YET_RECRUITING
Changzhou
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical University
RECRUITING
Chongqing
The Second Hospital of Dalian Medical University
RECRUITING
Dalian
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Nanfang Hospital of Southern Medical University
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
The First Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Anhui Provincial Hospital (The First Affiliated Hospital of University of Science and Technology of China)
NOT_YET_RECRUITING
Hefei
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
Huai'an First People's Hospital
NOT_YET_RECRUITING
Huai'an
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
Shandong Cancer Hospital
RECRUITING
Jinan
Shandong Provincial Hospital
NOT_YET_RECRUITING
Jinan
Jining First People's Hospital
NOT_YET_RECRUITING
Jining
The First Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
Gansu Provincial People's Hospital
NOT_YET_RECRUITING
Lanzhou
Linyi City Cancer Hospital
RECRUITING
Linyi
The First Affiliated Hospital of Henan University of Science and Technology
NOT_YET_RECRUITING
Luoyang
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Jiangsu Province Hospital
RECRUITING
Nanjing
The First Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITING
Nanning
Nanyang City Center Hospital
RECRUITING
Nanyang
The People's Hospital Affiliated to Ningbo University
NOT_YET_RECRUITING
Ningbo
Huashan Hospital
RECRUITING
Shanghai
Shengjing Hospital affiliated to China Medical University
RECRUITING
Shenyang
The Fourth Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Shanxi Cancer Hospital
NOT_YET_RECRUITING
Taiyuan
The Second Hospital of Shanxi Medical University
NOT_YET_RECRUITING
Taiyuan
The Affiliated Hospital of North China University of Science and Technology
NOT_YET_RECRUITING
Tangshan
Blood Diseases Hospital of Chinese Academy of Medical Sciences
NOT_YET_RECRUITING
Tianjin
Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
The Affiliated Cancer Hospital of Xinjiang Medical University
RECRUITING
Ürümqi
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Shaanxi Provincial People's Hospital
NOT_YET_RECRUITING
Xi’an
The Second Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi’an
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Yibin Second People's Hospital
RECRUITING
Yibin
Yichang Central People's Hospital
NOT_YET_RECRUITING
Yichang
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
Henan Cancer Hospital
RECRUITING
Zhenzhou
The Affiliated Hospital of Zunyi Medical University
NOT_YET_RECRUITING
Zunyi
Contact Information
Primary
Alexia Lu
CO_HGRAC@innocarepharma.com
010-66609745
Time Frame
Start Date: 2024-05-15
Estimated Completion Date: 2031-07-25
Participants
Target number of participants: 226
Treatments
Experimental: ICP-248 in combination with Orelabrutinib
Sponsors
Leads: Beijing InnoCare Pharma Tech Co., Ltd.

This content was sourced from clinicaltrials.gov