Spots Global Cancer Trial Database for A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic Phase
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Trial Identification
Brief Title: A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic Phase
Official Title: A Phase 2, Randomized, Open Label, Pivotal Study to Evaluate the Efficacy and Safety of HQP1351 in CML CP Patients Who Are Resistant and/or Intolerant to First- and Second-Generation Tyrosine Kinase Inhibitors
Study ID: NCT04126681
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy of HQP1351 in patients with chronic myeloid leukemia in chronic phase (CML-CP) who are resistant and/or intolerant to first- and second-generation tyrosine kinase inhibitors. The efficacy of HQP1351 is determined by evaluating the subjects' event free survival (EFS).
Detailed Description: This is a phase 2, randomized, open label, pivotal study to evaluate the efficacy and safety of HQP1351 in CML CP patients who are resistant and/or intolerant to first- and second-generation TKIs in China. A total of 141 CML CP patients will be included in this study. After screening, eligible subjects will be randomized by 2:1 ratio to enter HQP1351 therapy cohort and best available therapy (BAT) cohort. When the subjects in the two cohorts reach EFS assessment, they can crossover to contralateral cohort if the investigator and Sponsor think they could be clinically benefited. During treatment, each subject will be assessed regularly for hematological, cytogenetic and molecular responses. At the same time, safety information also will be evaluated.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Peking University People's Hospital, Beijing, Beijing, China
Sun Yat-sen University Cancer Center, Guangzhou, Gongdong, China
Nanfang hospital of southern medical university, Guangzhou, Guangdong, China
Shenzhen Second People's Hospital, Shenzhen, Guangdong, China
The First affiliated hospital of Guangxi Medical University, Nanning, Guangxi, China
Henan Provincial Oncology Hospital, Zhengzhou, Henan, China
Henan Provincial people's Hospital, Zhengzhou, Henan, China
Tongji Hospital medical college Huazhong University of Science and Technology, Wuhan, Hubei, China
Union Hospital medical college Huazhong University of Science and Technology, Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Xiangya Hospital Central South University, Changsha, Hunan, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
The First affiliated hospital of Nanchang University, Nanchang, Jiangxi, China
First Hospital of Jilin University, Changchun, Jilin, China
The Affiliated hospital of Qingdao University, Qingdao, Shandong, China
Qilu hospital of Shandong University, Jinan, Shangdong, China
Ruijing Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
Blood Diseases Hospital Chinese Academy of Medical Sciences, Tianjin, Tianjin, China
The First Affiliated Hospital, Zhejiang University School of Medicine(hematology dept), Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine(HSCTdept), Hangzhou, Zhejiang, China
Contact Details
Name: Xiaojun Huang, Professor
Affiliation: Peking University People's Hospital
Role: PRINCIPAL_INVESTIGATOR
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