A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)
Start Date
8/31/2023
Completion Date
6/30/2029
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).
Detailed Description
Comparing efficacy and safety of olverembatinib in combination with chemotherapy (investigational arm) vs. investigator's choice of TKI in combination with chemotherapy (control arm).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Olverembatinib
Investigator's choice of TKI
Conditions
Locations
Ascentage Investigative Site #1044
Birmingham, Alabama 35233
United States
Ascentage Investigative Site #1062
Duarte, California 91010
United States
Ascentage Investigative Site #1134
Los Angeles, California 90048
United States
Ascentage Investigative Site #1059
Los Angeles, California 90095
United States
Ascentage Investigative Site #1142
Miami, Florida 33155
United States
Ascentage Investigative Site #1045
Augusta, Georgia 30912
United States
Ascentage Investigative Site #1158
Indianapolis, Indiana 46202
United States
Ascentage Investigative Site #1069
Indianapolis, Indiana 46237
United States
Ascentage Investigative Site #1084
Lexington, Kentucky 40536
United States
Ascentage Investigative Site #1064
Hackensack, New Jersey 07601
United States
Ascentage Investigative Site #1098
New Brunswick, New Jersey 08901
United States
Ascentage Investigative Site #1160
Stony Brook, New York 11794
United States
Ascentage Investigative Site #1151
The Bronx, New York 10461
United States
Ascentage Investigative Site #1501
Houston, Texas 77030
United States
Ascentage Investigative Site #1806
Seattle, Washington 98104
United States
Ascentage Investigative Site #1155
Morgantown, West Virginia 26506
United States
Royal North Shore Hospital
St Leonards, New South Wales
Australia
Royal Adelaide Hospital
Adelaide, South Australia 5000
Australia
Alfred Health
Melbourne, Victoria 3004
Australia
Royal Perth Hospital
Perth, Washington 6000
Australia
The First Affiliated Hospital of Bengbu Medical School
Bengbu, Anhui 233000
China
Xinqiao Hospital of Army Medical University
Chongqing, Chongqing Municipality 214426
China
Guangdong Province People's Hospital
Guangdong, Guangzhou 510080
China
Nanfang Hospital of Southern Medical University
Guangdong, Guangzhou 510515
China
Henan Cancer Hospital
Zhengzhou, Henan 450003
China
Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei 430022
China
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu 215006
China
Shanghai Jiao Tong University School of Medicine Ruijin Hospital
Shanghai, Shanghai Municipality 200025
China
West China Hospital of Sichuan University
Chengdu, Sichuan 610044
China
Institute of Blood Transfusion of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality 215127
China
Ascentage Investigative Site #8647
Brno, 62500
Czechia
Ascentage Investigative Site #6305
Hradec Králové, 50005
Czechia
Ascentage Investigative Site #6304
Ostrava, 70852
Czechia
Ascentage Investigative Site #6302
Prague, 10034
Czechia
Ascentage Investigative Site #6309
Prague, 12800
Czechia
Ascentage Investigative Site #5020
Le Chesnay, 78150
France
Ascentage Investigative Site #5021
Lyon, 69008
France
Ascentage Investigative Site #5013
Nantes, 44000
France
Ascentage Investigative Site #5025
Nice, 06200
France
Ascentage Investigative Site #5019
Pessac, 33604
France
Ascentage Investigative Site #5024
Pierre-Bénite, 69495
France
Ascentage Investigative Site #5022
Poitiers, 86021
France
Ascentage Investigative Site #5018
Toulouse, 31059
France
Ascentage Investigative Site #5538
Bologna, 40138
Italy
Ascentage Investigative Site #5529
Meldola, 47014
Italy
Ascentage Investigative Site #5539
Milan, 20132
Italy
Ascentage Investigative Site #5533
Monza, 20900
Italy
Ascentage Investigative Site #5540
Ravenna, 48121
Italy
Ascentage Investigative Site #5531
Roma, 00138
Italy
Ascentage Investigative Site #5550
Torino, 10126
Italy
Ascentage Investigative Site #5536
Varese, 21100
Italy
Ascentage Investigative Site #6503
Bucharest, 020125
Romania
Ascentage Investigative Site #6502
Cluj-Napoca, 400015
Romania
Ascentage Investigative Site #6507
Craiova, 200143
Romania
Ascentage Investigative Site #6504
Iași, 700483
Romania
Ascentage Investigative Site #6602
Singapore, 119074
Singapore
Ascentage Investigative Site #6603
Singapore, 169608
Singapore
Ascentage Investigative Site #6604
Singapore, 308433
Singapore
Ascentage Investigative Site #8206
Busan, 49201
South Korea
Ascentage Investigative Site #8207
Busan, 49241
South Korea
Ascentage Investigative Site #8201
Seoul, 03080
South Korea
Ascentage Investigative Site #8202
Seoul, 05505
South Korea
Ascentage Investigative Site #8203
Seoul, 06591
South Korea
Ascentage Investigative Site #8208
Uijeongbu-si, 11759
South Korea
Ascentage Investigative Site #6018
Badalona, 08916
Spain
Ascentage Investigative Site #6019
Badalona, 08916
Spain
Ascentage Investigative Site #6020
Barcelona, 08035
Spain
Ascentage Investigative Site #6048
Cáceres, 10003
Spain
Ascentage Investigative Site #6016
Madrid, 20834
Spain
Ascentage Investigative Site #6049
Madrid, 20840
Spain
Ascentage Investigative Site #6035
Madrid, 28006
Spain
Ascentage Investigative Site #6013
Madrid, 28007
Spain
Ascentage Investigative Site #6011
Madrid, 28041
Spain
Ascentage Investigative Site #6021
Santander, 39008
Spain
Ascentage Investigative Site #6050
Seville, 41010
Spain
Ascentage Investigative Site #6017
Valencia, 6017
Spain
Ascentage Investigative Site #9201
Ankara, 06100
Turkey (Türkiye)
Ascentage Investigative Site #9204
Ankara, 06170
Turkey (Türkiye)
Ascentage Investigative Site #9212
Ankara, 06200
Turkey (Türkiye)
Ascentage Investigative Site #9209
Ankara, 06560
Turkey (Türkiye)
Ascentage Investigative Site #9205
Antalya, 07025
Turkey (Türkiye)
Ascentage Investigative Site #9203
Istanbul, 34381
Turkey (Türkiye)
Ascentage Investigative Site #9202
Izmir, 35100
Turkey (Türkiye)
Ascentage Investigative Site #9211
Kayseri, 38039
Turkey (Türkiye)
Ascentage Investigative Site #9208
Mersin, 33200
Turkey (Türkiye)
Ascentage Investigative Site #9220
Samsun, 55139
Turkey (Türkiye)
Ascentage Investigative Site #9210
Tekirdağ, 59030
Turkey (Türkiye)
Ascentage Investigative Site #7002
Birmingham, B15 2GW
United Kingdom
Ascentage Investigative Site #7034
Glasgow, G12 0YN
United Kingdom
Ascentage Investigative Site #7019
London, SW3 6JJ
United Kingdom