Study of Olverembatinib (HQP1351) in Patients With CML-CP

NCT06423911 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: HQP1351CG301
• Study Type: interventional
• Target: 333
• Locations: 16 countries
• Sites: 163

Brief 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.

Conditions

Chronic Myeloid Leukemia; CML; CML, Chronic Phase

Outcome Measures

Primary Outcomes (2)

• 24-Week MMR Rate (Part A)

  To compare the major molecular response (MMR) rate at 24 weeks for olverembatinib versus bosutinib

  24 weeks

• 24-Week MMR Rate (Part B)

  To evaluate the MMR rate by 24 weeks for olverembatinib in CML-CP patients with T315I mutation

  24 weeks

Secondary Outcomes (10)

• 96-Week MMR Rate (Part A)

  96 weeks

• 96-Week MMR Rate (Part B)

  96 weeks

• Cytogenic Response Rate (Part A)

  Through 96 weeks (i.e., at 24, 48, and 96 weeks)

• Cytogenic Response Rate (Part B)

  Through 96 weeks (i.e., at 24, 48, and 96 weeks)

• Progression Free Survival (PFS) (Part A)

  5 years after the last patient received the first study dose

Study Arms (2)

Part A, RCT, olverembatinib arm and bosutinib arm

OTHER

Randomized controlled part that is designed to compare the efficacy and safety of olverembatinib (investigational arm) versus bosutinib (control arm) in patients with CML-CP, previously treated with at least two TKIs

Drug: olverembatinib; Drug: Bosutinib

Part B, SAT, olverembatinib arm

OTHER

To evaluate the efficacy and safety of olverembatinib in the CML-CP patients with T315I mutation previously

Drug: olverembatinib

Interventions

olverembatinib DRUG

olverembatinib QOD

Part A, RCT, olverembatinib arm and bosutinib arm; Part B, SAT, olverembatinib arm

Bosutinib DRUG

Bosutnib QD

Part A, RCT, olverembatinib arm and bosutinib arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Diagnosis of CML-CP
• 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
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
• Patient has adequate organ function

You may not qualify if:

• Patients eligible for this study must not meet any of the following criteria:
• For Part A only: T315I or V299L mutation at any time prior to starting study treatment
• Active infection that requires systemic drug therapy
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
• Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients
• Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients
• Pregnant or nursing (lactating) women

Sponsors & Collaborators

• Ascentage Pharma Group Inc.: lead

Study Sites (163)

Ascentage Investigative Site #1044

Birmingham, Alabama, 35249, United States

RECRUITING

Ascentage Investigative Site #1112

Anchorage, Alaska, 99508, United States

RECRUITING

Ascentage Investigative Site #1111

Goodyear, Arizona, 85338, United States

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Ascentage Investigative Site #1062

Duarte, California, 91010, United States

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Ascentage Investigative Site #1099

Irvine, California, 92618, United States

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Ascentage Investigative Site #1075

La Jolla, California, 92037, United States

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Ascentage Investigative Site #1100

Long Beach, California, 90813, United States

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Ascentage Investigative Site #1059

Los Angeles, California, 90024, United States

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Ascentage Investigative Site #1121

Sacramento, California, 95817, United States

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Ascentage Investigative Site #1109

Upland, California, 91786, United States

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Ascentage Investigative Site #1045

Augusta, Georgia, 30912, United States

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Ascentage Investigative Site #1110

Newnan, Georgia, 30265, United States

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Ascentage Investigative Site #1055

Chicago, Illinois, 60637, United States

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Ascentage Investigative Site #1095

Decatur, Illinois, 62526, United States

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Ascentage Investigative Site #1069

Indianapolis, Indiana, 46237, United States

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Ascentage Investigative Site #1065

Wichita, Kansas, 67214, United States

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Ascentage Investigative Site #1084

Lexington, Kentucky, 40536, United States

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Ascentage Investigative Site #1058

Louisville, Kentucky, 40202, United States

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Ascentage Investigative Site #1801

Baltimore, Maryland, 21201, United States

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Ascentage Investigative Site #1056

Detroit, Michigan, 48201, United States

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Ascentage Investigative Site #1023

Detroit, Michigan, 49254, United States

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Ascentage Investigative Site #1088

St Louis, Missouri, 63108, United States

RECRUITING

Ascentage Investigative Site #1097

Lincoln, Nebraska, 68506, United States

NOT YET RECRUITING

Ascentage Investigative Site #1066

Las Vegas, Nevada, 89169, United States

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Ascentage Investigative Site #1113

Reno, Nevada, 89511, United States

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Ascentage Investigative Site #1064

Hackensack, New Jersey, 07601, United States

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Ascentage Investigative Site #1054

Morristown, New Jersey, 07960, United States

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Ascentage Investigative Site #1098

New Brunswick, New Jersey, 08901, United States

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Ascentage Investigative Site #1072

Albuquerque, New Mexico, 87102, United States

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Ascentage Investigative Site #1068

Rochester, New York, 14642, United States

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Ascentage Investigative Site #1053

Shirley, New York, 11967, United States

RECRUITING

Ascentage Investigative Site #1160

Stony Brook, New York, 11794, United States

NOT YET RECRUITING

Ascentage Investigative Site #1019

Greenville, North Carolina, 27858, United States

NOT YET RECRUITING

Ascentage Investigative Site #1043

Morrisville, North Carolina, 27560, United States

RECRUITING

Ascentage Investigative Site #1173

Cleveland, Ohio, 44111, United States

NOT YET RECRUITING

Ascentage Investigative Site #1096

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

Ascentage Investigative Site #1174

Mayfield Heights, Ohio, 44124, United States

NOT YET RECRUITING

Ascentage Investigative Site #1139

Portland, Oregon, 97239, United States

NOT YET RECRUITING

Ascentage Investigative Site #1057

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Ascentage Investigative Site #1022

Pittsburgh, Pennsylvania, 15232, United States

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Ascentage Investigative Site #1063

Chattanooga, Tennessee, 37404, United States

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Ascentage Investigative Site #1089

Nashville, Tennessee, 37203, United States

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Ascentage Investigative Site #1051

Amarillo, Texas, 79124, United States

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Ascentage Investigative Site #1036

Austin, Texas, 78705, United States

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Ascentage Investigative Site #1501

Houston, Texas, 77030, United States

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Ascentage Investigative Site #1050

Virginia Beach, Virginia, 23456, United States

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Ascentage Investigative Site #1136

Edmonds, Washington, 98026, United States

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Ascentage Investigative Site #1135

Issaquah, Washington, 98029, United States

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Ascentage Investigative Site #1806

Seattle, Washington, 98104, United States

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Ascentage Investigative Site #1510

Seattle, Washington, 98109, United States

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Ascentage Investigative Site #2107

Campbelltown, New South Wales, 2560, Australia

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Ascentage Investigative Site #2105

Liverpool, New South Wales, 2170, Australia

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Ascentage Investigative Site #2115

Adelaide, South Australia, 5000, Australia

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Ascentage Investigative Site #2106

Perth, Western Australia, 6000, Australia

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Ascentage Investigative Site #5211

Anderlecht, 1070, Belgium

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Ascentage Investigative Site #5212

Gilly, 6060, Belgium

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Ascentage Investigative Site #5208

Kortrijk, 8500, Belgium

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Ascentage Investigative Site #5209

Roeselare, 8800, Belgium

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Ascentage Investigative Site #5210

Yvoir, 5530, Belgium

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Ascentage Investigative Site #8004

Toronto, M5G 2M9, Canada

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Ascentage Investigative Site #5037

Amiens, 80054, France

RECRUITING

Ascentage Investigative Site #5015

Bobigny, 93000, France

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Ascentage Investigative Site #5017

Nice, 06202, France

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Ascentage Investigative Site #5016

Rouen, 76038, France

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Ascentage Investigative Site #5023

Toulouse, 31059, France

RECRUITING

Ascentage Investigative Site #5708

Berlin, 13353, Germany

RECRUITING

Ascentage Investigative Site #5709

Dresden, 01307, Germany

RECRUITING

Ascentage Investigative Site #9118

Bangalore, 560027, India

ACTIVE NOT RECRUITING

Ascentage Investigative Site #9120

Haryāna, 122002, India

ACTIVE NOT RECRUITING

Ascentage Investigative Site #9102

Haryāna, 124105, India

ACTIVE NOT RECRUITING

Ascentage Investigative Site #9110

Hyderabad, 500033, India

ACTIVE NOT RECRUITING

Ascentage Investigative Site #9116

Kolkata, 700014, India

ACTIVE NOT RECRUITING

Ascentage Investigative Site #9115

Kolkata, 700054, India

ACTIVE NOT RECRUITING

Ascentage Investigative Site #9101

New Delhi, 110029, India

ACTIVE NOT RECRUITING

Ascentage Investigative Site #9103

New Delhi, 110076, India

ACTIVE NOT RECRUITING

Ascentage Investigative Site #9119

Pune, 411001, India

ACTIVE NOT RECRUITING

Ascentage Investigative Site #9113

Thiruvananthapuram, 695011, India

ACTIVE NOT RECRUITING

Ascentage Investigative Site #5535

Bologna, 40138, Italy

RECRUITING

Ascentage Investigative Site #5534

Candiolo, 10060, Italy

RECRUITING

Ascentage Investigative Site #5527

Catania, 95123, Italy

RECRUITING

Ascentage Investigative Site #5523

Lecce, 73100, Italy

RECRUITING

Ascentage Investigative Site #5529

Meldola, 47014, Italy

RECRUITING

Ascentage Investigative Site #5537

Messina, 98124, Italy

NOT YET RECRUITING

Ascentage Investigative Site #5553

Milan, 20122, Italy

RECRUITING

Ascentage Investigative Site #5530

Naples, 80131, Italy

RECRUITING

Ascentage Investigative Site #5524

Novara, 28100, Italy

RECRUITING

Ascentage Investigative Site #5525

Padova, 35128, Italy

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Ascentage Investigative Site #5526

Pisa, 56126, Italy

RECRUITING

Ascentage Investigative Site #5528

Roma, 00144, Italy

RECRUITING

Ascentage Investigative Site #5522

Roma, 00161, Italy

RECRUITING

Ascentage Investigative Site #5510

Roma, 00168, Italy

NOT YET RECRUITING

Ascentage Investigative Site #5552

Torino, 10126, Italy

NOT YET RECRUITING

Ascentage Investigative Site #5521

Torino, 10128, Italy

RECRUITING

Ascentage Investigative Site #5536

Varese, 21100, Italy

RECRUITING

Ascentage Investigative Site #8101

Ehime, 790-8524, Japan

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Ascentage Investigative Site #8102

Kyoto, 602-8566, Japan

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Ascentage Investigative Site #8112

Okayama, 701-1192, Japan

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Ascentage Investigative Site #8105

Osaka, 565-0871, Japan

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Ascentage Investigative Site #8106

Sapporo, 003-0006, Japan

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Ascentage Investigative Site #8107

Sapporo, 060-8648, Japan

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Ascentage Investigative Site #8109

Tochigi, 321-0207, Japan

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Ascentage Investigative Site #8114

Tokyo, 113-8677, Japan

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Ascentage Investigative Site #8117

Tokyo, 130-8575, Japan

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Ascentage Investigative Site #8110

Tokyo, 141-8625, Japan

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Ascentage Investigative Site #8104

Yamagata, 990-9585, Japan

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Ascentage Investigative Site #8103

Yamanashi, 409-3898, Japan

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Ascentage Investigative Site #4213

Gdansk, 80214, Poland

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Ascentage Investigative Site #4212

Gdansk, 80219, Poland

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Ascentage Investigative Site #4207

Katowice, 40519, Poland

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Ascentage Investigative Site #4209

Krakow, 30688, Poland

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Ascentage Investigative Site #4211

Lodz, 93513, Poland

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Ascentage Investigative Site #4214

Torun, 87100, Poland

RECRUITING

Ascentage Investigative Site #4206

Warsaw, 00791, Poland

NOT YET RECRUITING

Ascentage Investigative Site #4210

Wałbrzych, 58309, Poland

RECRUITING

Ascentage Investigative Site #3227

Moscow, 125167, Russia

ACTIVE NOT RECRUITING

Ascentage Investigative Site #3228

Saint Petersburg, 191024, Russia

ACTIVE NOT RECRUITING

Ascentage Investigative Site #3213

Saint Petersburg, 194291, Russia

ACTIVE NOT RECRUITING

Ascentage Investigative Site #3212

Saint Petersburg, 197341, Russia

ACTIVE NOT RECRUITING

Ascentage Investigative Site #6602

Singapore, 117599, Singapore

RECRUITING

Ascentage Investigative Site #6601

Singapore, 168583, Singapore

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Ascentage Investigative Site #8206

Busan, 49201, South Korea

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Ascentage Investigative Site #8207

Busan, 49241, South Korea

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Ascentage Investigative Site #8204

Gyeonggi-do, 13620, South Korea

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Ascentage Investigative Site #8201

Seoul, 03080, South Korea

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Ascentage Investigative Site #8202

Seoul, 05505, South Korea

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Ascentage Investigative Site #8205

Seoul, 06351, South Korea

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Ascentage Investigative Site #8203

Seoul, 06591, South Korea

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Ascentage Investigative Ste #8208

Uijeongbu-si, 11749, South Korea

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Ascentage Investigative Site #6015

Badalona, 08916, Spain

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Ascentage Investigative Site #6020

Barcelona, 08035, Spain

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Ascentage Investigative Site #6047

Elche, 03293, Spain

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Ascentage Investigative Site #6014

L'Hospitalet de Llobregat, 08906, Spain

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Ascentage Investigative Site #6035

Madrid, 28006, Spain

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Ascentage Investigative Site #6013

Madrid, 28007, Spain

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Ascentage Investigative Site #6033

Madrid, 28031, Spain

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Ascentage Investigative Site #6011

Madrid, 28041, Spain

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Ascentage Investigative Site #6032

Madrid, 28046, Spain

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Ascentage Investigative Site #6037

Majadahonda, 28222, Spain

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Ascentage Investigative Site #6012

Málaga, 29010, Spain

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Ascentage Investigative Site #6039

Málaga, 29010, Spain

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Ascentage Investigative Site #6051

Murcia, 30120, Spain

NOT YET RECRUITING

Ascentage Investigative Site #6036

Ourense, 32005, Spain

RECRUITING

Ascentage Investigative Site #6038

Valencia, 46017, Spain

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Ascentage Investigative Site #6041

Zaragoza, 50009, Spain

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Ascentage Investigative Site #9216

Adapazarı, 54100, Turkey (Türkiye)

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Ascentage Investigative Site #9218

Ankara, 06050, Turkey (Türkiye)

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Ascentage Investigative Site #9204

Ankara, 06170, Turkey (Türkiye)

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Ascentage Investigative Site #9215

Battalgazi, 44210, Turkey (Türkiye)

RECRUITING

Ascentage Investigative Site #9217

Çankaya, 06800, Turkey (Türkiye)

NOT YET RECRUITING

Ascentage Investigative Site #9219

Istanbul, 34452, Turkey (Türkiye)

NOT YET RECRUITING

Ascentage Investigative Site #9205

Kepez, 07025, Turkey (Türkiye)

RECRUITING

Ascentage Investigative Site #9208

Mezitli, 33200, Turkey (Türkiye)

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Ascentage Investigative Site #9213

Ortahisar, 61080, Turkey (Türkiye)

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Ascentage Investigative Site #9214

Samsun, 55270, Turkey (Türkiye)

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Ascentage Investigative Site #9212

Yenimahalle, 06200, Turkey (Türkiye)

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Ascentage Investigative Site #7017

Aberdeen, AB25 2ZN, United Kingdom

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Ascentage Investigative Site #7036

Birmingham, B15 2GW, United Kingdom

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Ascentage Investigative Site #7021

Boston, PE21 9QS, United Kingdom

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Ascentage Investigative Site #7037

Bradford, BD9 6RJ, United Kingdom

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Ascentage Investigative Site #7035

Liverpool, L7 8YA, United Kingdom

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Ascentage Investigative Site #7016

London, SE5 9RS, United Kingdom

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Ascentage Investigative Site #7015

London, W12 0HS, United Kingdom

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Ascentage Investigative Site #7018

Newport, NP20 2UB, United Kingdom

RECRUITING

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase

Interventions

olverembatinib; bosutinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elias Jabbour, M.D.

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ascentage Clinical Operations

CONTACT

301-291-5658; clinical-trials@ascentage.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Model Details: Part A (285 patients): Randomization to olverembatinib or bosutinib at 2:1 ratio. Part B in patients with T315I mutation (48 patients): Single-arm part; all enrolled patients receive olverembatinib.

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 21, 2024
• Study Start: February 5, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 10, 2028
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

US (50); IT (17); DE (2); CA (1); PL (8); GB (8); KR (8); AU (4); JP (12); RU (4); TU (11); IN (10); ES (16); FR (5); BE (5); SG (2)