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Study of Olverembatinib (HQP1351) in Patients With CML-CP
Sponsor: Ascentage Pharma Group Inc.
Summary
Study comparing efficacy and safety of olverembatinib (investigational arm) vs. bosutinib (control arm) in patients with CML-CP (Part A). Study will also evaluate efficacy and safety of olverembatinib (single-arm) in CML-CP patients with T315I mutation (Part B). Patients who meet ELN 2025 failure criteria while receiving bosutinib in Part A may be able to receive olverembatinib in crossover follow-on study.
Official title: A Global, Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML-CP)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
333
Start Date
2024-02-05
Completion Date
2028-07-10
Last Updated
2026-09-15
Healthy Volunteers
No
Interventions
olverembatinib
olverembatinib QOD
Bosutinib
Bosutnib QD
Locations (163)
Ascentage Investigative Site #1044
Birmingham, Alabama, United States
Ascentage Investigative Site #1112
Anchorage, Alaska, United States
Ascentage Investigative Site #1111
Goodyear, Arizona, United States
Ascentage Investigative Site #1062
Duarte, California, United States
Ascentage Investigative Site #1099
Irvine, California, United States
Ascentage Investigative Site #1075
La Jolla, California, United States
Ascentage Investigative Site #1100
Long Beach, California, United States
Ascentage Investigative Site #1059
Los Angeles, California, United States
Ascentage Investigative Site #1121
Sacramento, California, United States
Ascentage Investigative Site #1109
Upland, California, United States
Ascentage Investigative Site #1045
Augusta, Georgia, United States
Ascentage Investigative Site #1110
Newnan, Georgia, United States
Ascentage Investigative Site #1055
Chicago, Illinois, United States
Ascentage Investigative Site #1095
Decatur, Illinois, United States
Ascentage Investigative Site #1069
Indianapolis, Indiana, United States
Ascentage Investigative Site #1065
Wichita, Kansas, United States
Ascentage Investigative Site #1084
Lexington, Kentucky, United States
Ascentage Investigative Site #1058
Louisville, Kentucky, United States
Ascentage Investigative Site #1801
Baltimore, Maryland, United States
Ascentage Investigative Site #1056
Detroit, Michigan, United States
Ascentage Investigative Site #1023
Detroit, Michigan, United States
Ascentage Investigative Site #1088
St Louis, Missouri, United States
Ascentage Investigative Site #1097
Lincoln, Nebraska, United States
Ascentage Investigative Site #1066
Las Vegas, Nevada, United States
Ascentage Investigative Site #1113
Reno, Nevada, United States
Ascentage Investigative Site #1064
Hackensack, New Jersey, United States
Ascentage Investigative Site #1054
Morristown, New Jersey, United States
Ascentage Investigative Site #1098
New Brunswick, New Jersey, United States
Ascentage Investigative Site #1072
Albuquerque, New Mexico, United States
Ascentage Investigative Site #1068
Rochester, New York, United States
Ascentage Investigative Site #1053
Shirley, New York, United States
Ascentage Investigative Site #1160
Stony Brook, New York, United States
Ascentage Investigative Site #1019
Greenville, North Carolina, United States
Ascentage Investigative Site #1043
Morrisville, North Carolina, United States
Ascentage Investigative Site #1173
Cleveland, Ohio, United States
Ascentage Investigative Site #1096
Cleveland, Ohio, United States
Ascentage Investigative Site #1174
Mayfield Heights, Ohio, United States
Ascentage Investigative Site #1139
Portland, Oregon, United States
Ascentage Investigative Site #1057
Philadelphia, Pennsylvania, United States
Ascentage Investigative Site #1022
Pittsburgh, Pennsylvania, United States
Ascentage Investigative Site #1063
Chattanooga, Tennessee, United States
Ascentage Investigative Site #1089
Nashville, Tennessee, United States
Ascentage Investigative Site #1051
Amarillo, Texas, United States
Ascentage Investigative Site #1036
Austin, Texas, United States
Ascentage Investigative Site #1501
Houston, Texas, United States
Ascentage Investigative Site #1050
Virginia Beach, Virginia, United States
Ascentage Investigative Site #1136
Edmonds, Washington, United States
Ascentage Investigative Site #1135
Issaquah, Washington, United States
Ascentage Investigative Site #1806
Seattle, Washington, United States
Ascentage Investigative Site #1510
Seattle, Washington, United States
Ascentage Investigative Site #2107
Campbelltown, New South Wales, Australia
Ascentage Investigative Site #2105
Liverpool, New South Wales, Australia
Ascentage Investigative Site #2115
Adelaide, South Australia, Australia
Ascentage Investigative Site #2106
Perth, Western Australia, Australia
Ascentage Investigative Site #5211
Anderlecht, Belgium
Ascentage Investigative Site #5212
Gilly, Belgium
Ascentage Investigative Site #5208
Kortrijk, Belgium
Ascentage Investigative Site #5209
Roeselare, Belgium
Ascentage Investigative Site #5210
Yvoir, Belgium
Ascentage Investigative Site #8004
Toronto, Canada
Ascentage Investigative Site #5037
Amiens, France
Ascentage Investigative Site #5015
Bobigny, France
Ascentage Investigative Site #5017
Nice, France
Ascentage Investigative Site #5016
Rouen, France
Ascentage Investigative Site #5023
Toulouse, France
Ascentage Investigative Site #5708
Berlin, Germany
Ascentage Investigative Site #5709
Dresden, Germany
Ascentage Investigative Site #9118
Bangalore, India
Ascentage Investigative Site #9120
Haryāna, India
Ascentage Investigative Site #9102
Haryāna, India
Ascentage Investigative Site #9110
Hyderabad, India
Ascentage Investigative Site #9116
Kolkata, India
Ascentage Investigative Site #9115
Kolkata, India
Ascentage Investigative Site #9101
New Delhi, India
Ascentage Investigative Site #9103
New Delhi, India
Ascentage Investigative Site #9119
Pune, India
Ascentage Investigative Site #9113
Thiruvananthapuram, India
Ascentage Investigative Site #5535
Bologna, Italy
Ascentage Investigative Site #5534
Candiolo, Italy
Ascentage Investigative Site #5527
Catania, Italy
Ascentage Investigative Site #5523
Lecce, Italy
Ascentage Investigative Site #5529
Meldola, Italy
Ascentage Investigative Site #5537
Messina, Italy
Ascentage Investigative Site #5553
Milan, Italy
Ascentage Investigative Site #5530
Naples, Italy
Ascentage Investigative Site #5524
Novara, Italy
Ascentage Investigative Site #5525
Padova, Italy
Ascentage Investigative Site #5526
Pisa, Italy
Ascentage Investigative Site #5528
Roma, Italy
Ascentage Investigative Site #5522
Roma, Italy
Ascentage Investigative Site #5510
Roma, Italy
Ascentage Investigative Site #5552
Torino, Italy
Ascentage Investigative Site #5521
Torino, Italy
Ascentage Investigative Site #5536
Varese, Italy
Ascentage Investigative Site #8101
Ehime, Japan
Ascentage Investigative Site #8102
Kyoto, Japan
Ascentage Investigative Site #8112
Okayama, Japan
Ascentage Investigative Site #8105
Osaka, Japan
Ascentage Investigative Site #8106
Sapporo, Japan
Ascentage Investigative Site #8107
Sapporo, Japan
Ascentage Investigative Site #8109
Tochigi, Japan
Ascentage Investigative Site #8114
Tokyo, Japan
Ascentage Investigative Site #8117
Tokyo, Japan
Ascentage Investigative Site #8110
Tokyo, Japan
Ascentage Investigative Site #8104
Yamagata, Japan
Ascentage Investigative Site #8103
Yamanashi, Japan
Ascentage Investigative Site #4213
Gdansk, Poland
Ascentage Investigative Site #4212
Gdansk, Poland
Ascentage Investigative Site #4207
Katowice, Poland
Ascentage Investigative Site #4209
Krakow, Poland
Ascentage Investigative Site #4211
Lodz, Poland
Ascentage Investigative Site #4214
Torun, Poland
Ascentage Investigative Site #4206
Warsaw, Poland
Ascentage Investigative Site #4210
Wałbrzych, Poland
Ascentage Investigative Site #3227
Moscow, Russia
Ascentage Investigative Site #3228
Saint Petersburg, Russia
Ascentage Investigative Site #3213
Saint Petersburg, Russia
Ascentage Investigative Site #3212
Saint Petersburg, Russia
Ascentage Investigative Site #6602
Singapore, Singapore
Ascentage Investigative Site #6601
Singapore, Singapore
Ascentage Investigative Site #8206
Busan, South Korea
Ascentage Investigative Site #8207
Busan, South Korea
Ascentage Investigative Site #8204
Gyeonggi-do, South Korea
Ascentage Investigative Site #8201
Seoul, South Korea
Ascentage Investigative Site #8202
Seoul, South Korea
Ascentage Investigative Site #8205
Seoul, South Korea
Ascentage Investigative Site #8203
Seoul, South Korea
Ascentage Investigative Ste #8208
Uijeongbu-si, South Korea
Ascentage Investigative Site #6015
Badalona, Spain
Ascentage Investigative Site #6020
Barcelona, Spain
Ascentage Investigative Site #6047
Elche, Spain
Ascentage Investigative Site #6014
L'Hospitalet de Llobregat, Spain
Ascentage Investigative Site #6035
Madrid, Spain
Ascentage Investigative Site #6013
Madrid, Spain
Ascentage Investigative Site #6033
Madrid, Spain
Ascentage Investigative Site #6011
Madrid, Spain
Ascentage Investigative Site #6032
Madrid, Spain
Ascentage Investigative Site #6037
Majadahonda, Spain
Ascentage Investigative Site #6012
Málaga, Spain
Ascentage Investigative Site #6039
Málaga, Spain
Ascentage Investigative Site #6051
Murcia, Spain
Ascentage Investigative Site #6036
Ourense, Spain
Ascentage Investigative Site #6038
Valencia, Spain
Ascentage Investigative Site #6041
Zaragoza, Spain
Ascentage Investigative Site #9216
Adapazarı, Turkey (Türkiye)
Ascentage Investigative Site #9218
Ankara, Turkey (Türkiye)
Ascentage Investigative Site #9204
Ankara, Turkey (Türkiye)
Ascentage Investigative Site #9215
Battalgazi, Turkey (Türkiye)
Ascentage Investigative Site #9217
Çankaya, Turkey (Türkiye)
Ascentage Investigative Site #9219
Istanbul, Turkey (Türkiye)
Ascentage Investigative Site #9205
Kepez, Turkey (Türkiye)
Ascentage Investigative Site #9208
Mezitli, Turkey (Türkiye)
Ascentage Investigative Site #9213
Ortahisar, Turkey (Türkiye)
Ascentage Investigative Site #9214
Samsun, Turkey (Türkiye)
Ascentage Investigative Site #9212
Yenimahalle, Turkey (Türkiye)
Ascentage Investigative Site #7017
Aberdeen, United Kingdom
Ascentage Investigative Site #7036
Birmingham, United Kingdom
Ascentage Investigative Site #7021
Boston, United Kingdom
Ascentage Investigative Site #7037
Bradford, United Kingdom
Ascentage Investigative Site #7035
Liverpool, United Kingdom
Ascentage Investigative Site #7016
London, United Kingdom
Ascentage Investigative Site #7015
London, United Kingdom
Ascentage Investigative Site #7018
Newport, United Kingdom