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
Status: Recruiting
Location: See all (85) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)
• Expected survival of at least 3 months
• ECOG ≤ 2
• Adequate organ function
Locations
United States
Alabama
Ascentage Investigative Site #1044
NOT_YET_RECRUITING
Birmingham
California
Ascentage Investigative Site #1062
NOT_YET_RECRUITING
Duarte
Ascentage Investigative Site #1059
NOT_YET_RECRUITING
Los Angeles
Ascentage Investigative Site #1134
NOT_YET_RECRUITING
Los Angeles
Florida
Ascentage Investigative Site #1142
NOT_YET_RECRUITING
Miami
Georgia
Ascentage Investigative Site #1045
NOT_YET_RECRUITING
Augusta
Indiana
Ascentage Investigative Site #1069
NOT_YET_RECRUITING
Indianapolis
Ascentage Investigative Site #1158
NOT_YET_RECRUITING
Indianapolis
Kentucky
Ascentage Investigative Site #1084
NOT_YET_RECRUITING
Lexington
New Jersey
Ascentage Investigative Site #1064
NOT_YET_RECRUITING
Hackensack
Ascentage Investigative Site #1098
NOT_YET_RECRUITING
New Brunswick
New York
Ascentage Investigative Site #1160
NOT_YET_RECRUITING
Stony Brook
Ascentage Investigative Site #1151
NOT_YET_RECRUITING
The Bronx
Texas
Ascentage Investigative Site #1501
NOT_YET_RECRUITING
Houston
Washington
Ascentage Investigative Site #1806
NOT_YET_RECRUITING
Seattle
West Virginia
Ascentage Investigative Site #1155
NOT_YET_RECRUITING
Morgantown
Other Locations
Australia
Royal Adelaide Hospital
ACTIVE_NOT_RECRUITING
Adelaide
Alfred Health
ACTIVE_NOT_RECRUITING
Melbourne
Royal Perth Hospital
ACTIVE_NOT_RECRUITING
Perth
Royal North Shore Hospital
ACTIVE_NOT_RECRUITING
St Leonards
China
The First Affiliated Hospital of Bengbu Medical School
NOT_YET_RECRUITING
Bengbu
West China Hospital of Sichuan University
RECRUITING
Chengdu
Xinqiao Hospital of Army Medical University
RECRUITING
Chongqing
Guangdong Province People's Hospital
RECRUITING
Guangdong
Nanfang Hospital of Southern Medical University
RECRUITING
Guangdong
Shanghai Jiao Tong University School of Medicine Ruijin Hospital
NOT_YET_RECRUITING
Shanghai
The First Affiliated Hospital of Suzhou University
RECRUITING
Suzhou
Institute of Blood Transfusion of Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
Wuhan
Henan Cancer Hospital
RECRUITING
Zhengzhou
France
Ascentage Investigative Site #5020
NOT_YET_RECRUITING
Le Chesnay
Ascentage Investigative Site #5021
NOT_YET_RECRUITING
Lyon
Ascentage Investigative Site #5013
NOT_YET_RECRUITING
Nantes
Ascentage Investigative Site #5025
NOT_YET_RECRUITING
Nice
Ascentage Investigative Site #5019
NOT_YET_RECRUITING
Pessac
Ascentage Investigative Site #5024
NOT_YET_RECRUITING
Pierre-bénite
Ascentage Investigative Site #5022
NOT_YET_RECRUITING
Poitiers
Ascentage Investigative Site #5018
NOT_YET_RECRUITING
Toulouse
Italy
Ascentage Investigative Site #5538
NOT_YET_RECRUITING
Bologna
Ascentage Investigative Site #5529
NOT_YET_RECRUITING
Meldola
Ascentage Investigative Site #5539
NOT_YET_RECRUITING
Milan
Ascentage Investigative Site #5533
NOT_YET_RECRUITING
Monza
Ascentage Investigative Site #5540
NOT_YET_RECRUITING
Ravenna
Ascentage Investigative Site #5531
NOT_YET_RECRUITING
Roma
Ascentage Investigative Site #5550
NOT_YET_RECRUITING
Torino
Ascentage Investigative Site #5536
NOT_YET_RECRUITING
Varese
Republic of Korea
Ascentage Investigative Site #8206
NOT_YET_RECRUITING
Busan
Ascentage Investigative Site #8207
NOT_YET_RECRUITING
Busan
Ascentage Investigative Site #8201
NOT_YET_RECRUITING
Seoul
Ascentage Investigative Site #8202
NOT_YET_RECRUITING
Seoul
Ascentage Investigative Site #8203
NOT_YET_RECRUITING
Seoul
Ascentage Investigative Site #8208
NOT_YET_RECRUITING
Uijeongbu-si
Romania
Ascentage Investigative Site #6503
NOT_YET_RECRUITING
Bucharest
Ascentage Investigative Site #6502
NOT_YET_RECRUITING
Cluj-napoca
Ascentage Investigative Site #6507
NOT_YET_RECRUITING
Craiova
Ascentage Investigative Site #6504
NOT_YET_RECRUITING
Iași
Singapore
Ascentage Investigative Site #6602
NOT_YET_RECRUITING
Singapore
Ascentage Investigative Site #6603
NOT_YET_RECRUITING
Singapore
Ascentage Investigative Site #6604
NOT_YET_RECRUITING
Singapore
Spain
Ascentage Investigative Site #6018
NOT_YET_RECRUITING
Badalona
Ascentage Investigative Site #6019
NOT_YET_RECRUITING
Badalona
Ascentage Investigative Site #6020
NOT_YET_RECRUITING
Barcelona
Ascentage Investigative Site #6048
NOT_YET_RECRUITING
Cáceres
Ascentage Investigative Site #6011
NOT_YET_RECRUITING
Madrid
Ascentage Investigative Site #6013
NOT_YET_RECRUITING
Madrid
Ascentage Investigative Site #6016
NOT_YET_RECRUITING
Madrid
Ascentage Investigative Site #6035
NOT_YET_RECRUITING
Madrid
Ascentage Investigative Site #6049
NOT_YET_RECRUITING
Madrid
Ascentage Investigative Site #6021
NOT_YET_RECRUITING
Santander
Ascentage Investigative Site #6050
NOT_YET_RECRUITING
Seville
Ascentage Investigative Site #6017
NOT_YET_RECRUITING
Valencia
Turkey
Ascentage Investigative Site #9201
NOT_YET_RECRUITING
Ankara
Ascentage Investigative Site #9204
NOT_YET_RECRUITING
Ankara
Ascentage Investigative Site #9209
NOT_YET_RECRUITING
Ankara
Ascentage Investigative Site #9212
NOT_YET_RECRUITING
Ankara
Ascentage Investigative Site #9205
NOT_YET_RECRUITING
Antalya
Ascentage Investigative Site #9203
NOT_YET_RECRUITING
Istanbul
Ascentage Investigative Site #9202
NOT_YET_RECRUITING
Izmir
Ascentage Investigative Site #9211
NOT_YET_RECRUITING
Kayseri
Ascentage Investigative Site #9208
NOT_YET_RECRUITING
Mersin
Ascentage Investigative Site #9220
NOT_YET_RECRUITING
Samsun
Ascentage Investigative Site #9210
NOT_YET_RECRUITING
Tekirdağ
United Kingdom
Ascentage Investigative Site #7002
NOT_YET_RECRUITING
Birmingham
Ascentage Investigative Site #7034
NOT_YET_RECRUITING
Glasgow
Ascentage Investigative Site #7019
NOT_YET_RECRUITING
London
Contact Information
Primary
Ascentage Clinical Operations
clinical-trials@ascentage.com
301-291-5658
Time Frame
Start Date: 2023-08-31
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 350
Treatments
Experimental: Olverembatinib
Olverembatinib in combination with chemotherapy
Active_comparator: Investigator's choice of TKI
Investigator's choice of TKI in combination with chemotherapy
Related Therapeutic Areas
Sponsors
Collaborators: Guangzhou Healthquest Pharma Co., Ltd
Leads: Ascentage Pharma Group Inc.