RecruitingRecruiting
Study of Olverembatinib (HQP1351) in Patients With CML-CP
NCT06423911 · Ascentage Pharma Group Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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)
About this study
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.
Eligibility criteria
Inclusion Criteria
Patients eligible for inclusion in this study must meet all of the following criteria:
1. Age ≥ 18 years old
2. Diagnosis of CML-CP
3. Part A: Previously treated with at least two approved TKIs; Part B: T315I mutation at screening and previously treated with at least one approved TKI, with no other effective and/or tolerable therapies available
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
5. Patient has adequate organ function
Exclusion Criteria
Patients eligible for this study must not meet any of the following criteria:
1. For Part A only: T315I or V299L mutation at any time prior to starting study treatment
2. Active infection that requires systemic drug therapy
3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
4. Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients
5. Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients
6. Pregnant or nursing (lactating) women
Study design
Enrollment target: 333 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-02-05
Estimated completion: 2028-07-10
Last updated: 2026-09-15
Interventions
Drug: olverembatinibDrug: Bosutinib
Primary outcomes
- • 24-Week MMR Rate (Part A) (24 weeks)
- • 24-Week MMR Rate (Part B) (24 weeks)
Sponsor
Ascentage Pharma Group Inc. · industry
Contacts & investigators
ContactAscentage Clinical Operations · contact · clinical-trials@ascentage.com · 301-291-5658
InvestigatorElias Jabbour, M.D. · principal_investigator, M.D. Anderson Cancer Center
All locations (163)
Ascentage Investigative Site #1044Recruiting
Birmingham, Alabama, United States
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Anchorage, Alaska, United States
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Goodyear, Arizona, United States
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Duarte, California, United States
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Irvine, California, United States
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La Jolla, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Sacramento, California, United States
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Upland, California, United States
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Augusta, Georgia, United States
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Newnan, Georgia, United States
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Chicago, Illinois, United States
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Decatur, Illinois, United States
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Indianapolis, Indiana, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Detroit, Michigan, United States
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Detroit, Michigan, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Hackensack, New Jersey, United States
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Morristown, New Jersey, United States
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New Brunswick, New Jersey, United States
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Albuquerque, New Mexico, United States
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Rochester, New York, United States
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Shirley, New York, United States
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Stony Brook, New York, United States
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Greenville, North Carolina, United States
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Morrisville, North Carolina, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Mayfield Heights, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Houston, Texas, United States
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Virginia Beach, Virginia, United States
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Edmonds, Washington, United States
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Issaquah, Washington, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Campbelltown, New South Wales, Australia
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Liverpool, New South Wales, Australia
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Adelaide, South Australia, Australia
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Perth, Western Australia, Australia
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Anderlecht, Belgium
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Gilly, Belgium
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Kortrijk, Belgium
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Roeselare, Belgium
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Yvoir, Belgium
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Toronto, Canada
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Amiens, France
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Bobigny, France
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Nice, France
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Rouen, France
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Toulouse, France
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Berlin, Germany
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Dresden, Germany
Ascentage Investigative Site #9118Active Not Recruiting
Bangalore, India
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Haryāna, India
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Haryāna, India
Ascentage Investigative Site #9110Active Not Recruiting
Hyderabad, India
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Kolkata, India
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Kolkata, India
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New Delhi, India
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New Delhi, India
Ascentage Investigative Site #9119Active Not Recruiting
Pune, India
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Thiruvananthapuram, India
Ascentage Investigative Site #5535Recruiting
Bologna, Italy
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Candiolo, Italy
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Catania, Italy
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Lecce, Italy
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Meldola, Italy
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Messina, Italy
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Milan, Italy
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Naples, Italy
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Novara, Italy
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Padova, Italy
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Pisa, Italy
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Roma, Italy
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Roma, Italy
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Roma, Italy
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Torino, Italy
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Torino, Italy
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Varese, Italy
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Ehime, Japan
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Kyoto, Japan
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Okayama, Japan
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Osaka, Japan
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Sapporo, Japan
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Sapporo, Japan
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Tochigi, Japan
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Tokyo, Japan
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Tokyo, Japan
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Tokyo, Japan
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Yamagata, Japan
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Yamanashi, Japan
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Gdansk, Poland
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Gdansk, Poland
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Katowice, Poland
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Krakow, Poland
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Lodz, Poland
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Torun, Poland
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Warsaw, Poland
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Wałbrzych, Poland
Ascentage Investigative Site #3227Active Not Recruiting
Moscow, Russia
Ascentage Investigative Site #3228Active Not Recruiting
Saint Petersburg, Russia
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Singapore, Singapore
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Singapore, Singapore
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Busan, South Korea
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Busan, South Korea
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Gyeonggi-do, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Uijeongbu-si, South Korea
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Badalona, Spain
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Barcelona, Spain
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Elche, Spain
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L'Hospitalet de Llobregat, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Majadahonda, Spain
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Málaga, Spain
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Málaga, Spain
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Murcia, Spain
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Ourense, Spain
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Valencia, Spain
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Zaragoza, Spain
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Adapazarı, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Battalgazi, Turkey (Türkiye)
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Çankaya, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Kepez, Turkey (Türkiye)
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Mezitli, Turkey (Türkiye)
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Ortahisar, Turkey (Türkiye)
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Samsun, Turkey (Türkiye)
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Yenimahalle, Turkey (Türkiye)
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Aberdeen, United Kingdom
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Birmingham, United Kingdom
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Boston, United Kingdom
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Bradford, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Newport, United Kingdom