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A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)
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 investigator's choice of tyrosine kinase inhibitor (TKI) combined with chemotherapy in subjects with newly-diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL).
Official title: A Pivotal Registrational Phase 3 Study of Olverembatinib Combined With Chemotherapy Versus Investigator's Choice of TKI Combined With Chemotherapy in Patients With Newly Diagnosed Ph+ ALL
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2023-08-31
Completion Date
2029-06-30
Last Updated
2026-04-30
Healthy Volunteers
No
Interventions
Olverembatinib
Oral (PO) once every other day (QOD).
Investigator's choice of TKI
Oral (PO) once daily (QD).
Locations (90)
Ascentage Investigative Site #1044
Birmingham, Alabama, United States
Ascentage Investigative Site #1062
Duarte, California, United States
Ascentage Investigative Site #1134
Los Angeles, California, United States
Ascentage Investigative Site #1059
Los Angeles, California, United States
Ascentage Investigative Site #1142
Miami, Florida, United States
Ascentage Investigative Site #1045
Augusta, Georgia, United States
Ascentage Investigative Site #1158
Indianapolis, Indiana, United States
Ascentage Investigative Site #1069
Indianapolis, Indiana, United States
Ascentage Investigative Site #1084
Lexington, Kentucky, United States
Ascentage Investigative Site #1064
Hackensack, New Jersey, United States
Ascentage Investigative Site #1098
New Brunswick, New Jersey, United States
Ascentage Investigative Site #1160
Stony Brook, New York, United States
Ascentage Investigative Site #1151
The Bronx, New York, United States
Ascentage Investigative Site #1501
Houston, Texas, United States
Ascentage Investigative Site #1806
Seattle, Washington, United States
Ascentage Investigative Site #1155
Morgantown, West Virginia, United States
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 Hospital 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
Ascentage Investigative Site #8647
Brno, Czechia
Ascentage Investigative Site #6305
Hradec Králové, Czechia
Ascentage Investigative Site #6304
Ostrava, Czechia
Ascentage Investigative Site #6302
Prague, Czechia
Ascentage Investigative Site #6309
Prague, Czechia
Ascentage Investigative Site #5020
Le Chesnay, France
Ascentage Investigative Site #5021
Lyon, France
Ascentage Investigative Site #5013
Nantes, France
Ascentage Investigative Site #5025
Nice, France
Ascentage Investigative Site #5019
Pessac, France
Ascentage Investigative Site #5024
Pierre-Bénite, France
Ascentage Investigative Site #5022
Poitiers, France
Ascentage Investigative Site #5018
Toulouse, France
Ascentage Investigative Site #5538
Bologna, Italy
Ascentage Investigative Site #5529
Meldola, Italy
Ascentage Investigative Site #5539
Milan, Italy
Ascentage Investigative Site #5533
Monza, Italy
Ascentage Investigative Site #5540
Ravenna, Italy
Ascentage Investigative Site #5531
Roma, Italy
Ascentage Investigative Site #5550
Torino, Italy
Ascentage Investigative Site #5536
Varese, Italy
Ascentage Investigative Site #6503
Bucharest, Romania
Ascentage Investigative Site #6502
Cluj-Napoca, Romania
Ascentage Investigative Site #6507
Craiova, Romania
Ascentage Investigative Site #6504
Iași, Romania
Ascentage Investigative Site #6602
Singapore, Singapore
Ascentage Investigative Site #6603
Singapore, Singapore
Ascentage Investigative Site #6604
Singapore, Singapore
Ascentage Investigative Site #8206
Busan, South Korea
Ascentage Investigative Site #8207
Busan, South Korea
Ascentage Investigative Site #8201
Seoul, South Korea
Ascentage Investigative Site #8202
Seoul, South Korea
Ascentage Investigative Site #8203
Seoul, South Korea
Ascentage Investigative Site #8208
Uijeongbu-si, South Korea
Ascentage Investigative Site #6018
Badalona, Spain
Ascentage Investigative Site #6019
Badalona, Spain
Ascentage Investigative Site #6020
Barcelona, Spain
Ascentage Investigative Site #6048
Cáceres, Spain
Ascentage Investigative Site #6016
Madrid, Spain
Ascentage Investigative Site #6049
Madrid, Spain
Ascentage Investigative Site #6035
Madrid, Spain
Ascentage Investigative Site #6013
Madrid, Spain
Ascentage Investigative Site #6011
Madrid, Spain
Ascentage Investigative Site #6021
Santander, Spain
Ascentage Investigative Site #6050
Seville, Spain
Ascentage Investigative Site #6017
Valencia, Spain
Ascentage Investigative Site #9201
Ankara, Turkey (Türkiye)
Ascentage Investigative Site #9204
Ankara, Turkey (Türkiye)
Ascentage Investigative Site #9212
Ankara, Turkey (Türkiye)
Ascentage Investigative Site #9209
Ankara, Turkey (Türkiye)
Ascentage Investigative Site #9205
Antalya, Turkey (Türkiye)
Ascentage Investigative Site #9203
Istanbul, Turkey (Türkiye)
Ascentage Investigative Site #9202
Izmir, Turkey (Türkiye)
Ascentage Investigative Site #9211
Kayseri, Turkey (Türkiye)
Ascentage Investigative Site #9208
Mersin, Turkey (Türkiye)
Ascentage Investigative Site #9220
Samsun, Turkey (Türkiye)
Ascentage Investigative Site #9210
Tekirdağ, Turkey (Türkiye)
Ascentage Investigative Site #7002
Birmingham, United Kingdom
Ascentage Investigative Site #7034
Glasgow, United Kingdom
Ascentage Investigative Site #7019
London, United Kingdom