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A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ALL.
Sponsor: Ascentage Pharma Group Inc.
Summary
A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of Olverembatinib combined with chemotherapy versus Imatinib combined with chemotherapy in subjects with newly diagnosed Ph+ALL.
Official title: A Pivotal Registrational Phase 3 Study of Olverembatinib Combined With Chemotherapy Versus Imatinib Combined With Chemotherapy in Patients With Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ALL)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2023-08-31
Completion Date
2028-10-31
Last Updated
2024-11-07
Healthy Volunteers
No
Conditions
Interventions
Olverembatinib
Orally, once every other day (QOD).
Imatinib
Orally, once daily (QD).
Locations (14)
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Alfred Health
Melbourne, Victoria, Australia
Royal Perth Hospital
Perth, Washington, Australia
The First Affiliated Hospitalo of Bengbu Medical School
Bengbu, Anhui, China
Xinqiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
Guangdong Province People's Hospital
Guangdong, Guangzhou, China
Nanfang Hospital of Southern Medical University
Guangdong, Guangzhou, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
The first affiliated hospital of Suzhou University
Suzhou, Jiangsu, China
Shanghai Jiao Tong University School of Medicine Ruijin Hospital
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Institute of blood transfusion of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China