RecruitingPhase 3NCT06423911

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

A Global, Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML-CP)

Sponsor

Ascentage Pharma Group Inc.

Enrollment

333 participants

Start Date

Feb 5, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Myeloid Leukemia CML CML, Chronic Phase

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called olverembatinib (HQP1351) in patients with chronic-phase chronic myeloid leukemia (CML), a blood cancer, who have not responded to or cannot tolerate other targeted treatments. It includes two groups: patients who failed two or more prior treatments, and those with a specific resistant mutation called T315I. **You may be eligible if...** - You are 18 or older - You have been diagnosed with chronic myeloid leukemia in the chronic phase - Part A: You have tried and failed at least two approved targeted treatments (TKIs) - Part B: You have a T315I mutation in your cancer (a specific genetic change that makes many drugs less effective) - Your overall health and organ function are adequate **You may NOT be eligible if...** - Part A only: You have ever had a T315I mutation - You have an active serious infection - You are pregnant or breastfeeding - You have a gut condition that would affect how you absorb the drug - You are allergic to olverembatinib or a related drug (bosutinib) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGolverembatinib

olverembatinib QOD

DRUGBosutinib

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

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NCT06423911

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