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NCT06051409PHASE3Recruiting

A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)

Ascentage Pharma Group Inc.

Start Date

8/31/2023

Completion Date

6/30/2029

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).

Detailed Description

Comparing efficacy and safety of olverembatinib in combination with chemotherapy (investigational arm) vs. investigator's choice of TKI in combination with chemotherapy (control arm).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL) 2. Expected survival of at least 3 months 3. ECOG ≤ 2 4. Adequate organ function Exclusion Criteria: 1. A history of chronic myeloid leukemia (CML) 2. Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly 3. Previous or current clinical CNS diseases 4. Autoimmune diseases that may involve the CNS 5. Use of therapeutic doses of anticoagulants and/or antiplatelet agents; low doses of anticoagulants or antiplatelet agents are allowed 6. Use a therapeutic drug that has drug interaction with the investigational drug due to other diseases within 7 days or within 5 half-lives (whichever is shorter) prior to the first receipt of the investigational drug 7. Uncontrolled heart diseases 8. Any venous thromboembolism in the 6 months prior to randomization, including but not limited to deep vein thrombosis (DVT) or pulmonary embolism 9. Use of prohibited drugs 10. Disease or medical condition that is unstable or may affect its safety or compliance with the study 11. Use of medications known to cause prolonged QT interval 12. Active infections requiring systemic treatment 13. Disease that severely affects the oral administration and absorption of drugs, or an active gastrointestinal ulcer 14. Contraindications to the use of glucocorticoids 15. Bleeding disorders unrelated to ALL 16. Plan to undergo major surgery 17. Allergy to drug ingredients, excipients, or their analogues in the study 18. Female subjects who are pregnant or breastfeeding or expect to become pregnant during the study period 19. Other malignant tumors within 2 years 20. Any symptom or illness that may interfere with the evaluation of the efficacy and safety of the investigational drug, or any other condition or condition that is not appropriate for participation in the study

Interventions

DRUG

Olverembatinib

DRUG

Investigator's choice of TKI

Interested in This Trial?

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Conditions

Ph+ ALLLeukemia, Lymphoblastic, Acute, Philadelphia-Positive

Locations

Ascentage Investigative Site #1044

Birmingham, Alabama 35233

United States

Ascentage Investigative Site #1062

Duarte, California 91010

United States

Ascentage Investigative Site #1134

Los Angeles, California 90048

United States

Ascentage Investigative Site #1059

Los Angeles, California 90095

United States

Ascentage Investigative Site #1142

Miami, Florida 33155

United States

Ascentage Investigative Site #1045

Augusta, Georgia 30912

United States

Ascentage Investigative Site #1158

Indianapolis, Indiana 46202

United States

Ascentage Investigative Site #1069

Indianapolis, Indiana 46237

United States

Ascentage Investigative Site #1084

Lexington, Kentucky 40536

United States

Ascentage Investigative Site #1064

Hackensack, New Jersey 07601

United States

Ascentage Investigative Site #1098

New Brunswick, New Jersey 08901

United States

Ascentage Investigative Site #1160

Stony Brook, New York 11794

United States

Ascentage Investigative Site #1151

The Bronx, New York 10461

United States

Ascentage Investigative Site #1501

Houston, Texas 77030

United States

Ascentage Investigative Site #1806

Seattle, Washington 98104

United States

Ascentage Investigative Site #1155

Morgantown, West Virginia 26506

United States

Royal North Shore Hospital

St Leonards, New South Wales

Australia

Royal Adelaide Hospital

Adelaide, South Australia 5000

Australia

Alfred Health

Melbourne, Victoria 3004

Australia

Royal Perth Hospital

Perth, Washington 6000

Australia

The First Affiliated Hospital of Bengbu Medical School

Bengbu, Anhui 233000

China

Xinqiao Hospital of Army Medical University

Chongqing, Chongqing Municipality 214426

China

Guangdong Province People's Hospital

Guangdong, Guangzhou 510080

China

Nanfang Hospital of Southern Medical University

Guangdong, Guangzhou 510515

China

Henan Cancer Hospital

Zhengzhou, Henan 450003

China

Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei 430022

China

The First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu 215006

China

Shanghai Jiao Tong University School of Medicine Ruijin Hospital

Shanghai, Shanghai Municipality 200025

China

West China Hospital of Sichuan University

Chengdu, Sichuan 610044

China

Institute of Blood Transfusion of Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality 215127

China

Ascentage Investigative Site #8647

Brno, 62500

Czechia

Ascentage Investigative Site #6305

Hradec Králové, 50005

Czechia

Ascentage Investigative Site #6304

Ostrava, 70852

Czechia

Ascentage Investigative Site #6302

Prague, 10034

Czechia

Ascentage Investigative Site #6309

Prague, 12800

Czechia

Ascentage Investigative Site #5020

Le Chesnay, 78150

France

Ascentage Investigative Site #5021

Lyon, 69008

France

Ascentage Investigative Site #5013

Nantes, 44000

France

Ascentage Investigative Site #5025

Nice, 06200

France

Ascentage Investigative Site #5019

Pessac, 33604

France

Ascentage Investigative Site #5024

Pierre-Bénite, 69495

France

Ascentage Investigative Site #5022

Poitiers, 86021

France

Ascentage Investigative Site #5018

Toulouse, 31059

France

Ascentage Investigative Site #5538

Bologna, 40138

Italy

Ascentage Investigative Site #5529

Meldola, 47014

Italy

Ascentage Investigative Site #5539

Milan, 20132

Italy

Ascentage Investigative Site #5533

Monza, 20900

Italy

Ascentage Investigative Site #5540

Ravenna, 48121

Italy

Ascentage Investigative Site #5531

Roma, 00138

Italy

Ascentage Investigative Site #5550

Torino, 10126

Italy

Ascentage Investigative Site #5536

Varese, 21100

Italy

Ascentage Investigative Site #6503

Bucharest, 020125

Romania

Ascentage Investigative Site #6502

Cluj-Napoca, 400015

Romania

Ascentage Investigative Site #6507

Craiova, 200143

Romania

Ascentage Investigative Site #6504

Iași, 700483

Romania

Ascentage Investigative Site #6602

Singapore, 119074

Singapore

Ascentage Investigative Site #6603

Singapore, 169608

Singapore

Ascentage Investigative Site #6604

Singapore, 308433

Singapore

Ascentage Investigative Site #8206

Busan, 49201

South Korea

Ascentage Investigative Site #8207

Busan, 49241

South Korea

Ascentage Investigative Site #8201

Seoul, 03080

South Korea

Ascentage Investigative Site #8202

Seoul, 05505

South Korea

Ascentage Investigative Site #8203

Seoul, 06591

South Korea

Ascentage Investigative Site #8208

Uijeongbu-si, 11759

South Korea

Ascentage Investigative Site #6018

Badalona, 08916

Spain

Ascentage Investigative Site #6019

Badalona, 08916

Spain

Ascentage Investigative Site #6020

Barcelona, 08035

Spain

Ascentage Investigative Site #6048

Cáceres, 10003

Spain

Ascentage Investigative Site #6016

Madrid, 20834

Spain

Ascentage Investigative Site #6049

Madrid, 20840

Spain

Ascentage Investigative Site #6035

Madrid, 28006

Spain

Ascentage Investigative Site #6013

Madrid, 28007

Spain

Ascentage Investigative Site #6011

Madrid, 28041

Spain

Ascentage Investigative Site #6021

Santander, 39008

Spain

Ascentage Investigative Site #6050

Seville, 41010

Spain

Ascentage Investigative Site #6017

Valencia, 6017

Spain

Ascentage Investigative Site #9201

Ankara, 06100

Turkey (Türkiye)

Ascentage Investigative Site #9204

Ankara, 06170

Turkey (Türkiye)

Ascentage Investigative Site #9212

Ankara, 06200

Turkey (Türkiye)

Ascentage Investigative Site #9209

Ankara, 06560

Turkey (Türkiye)

Ascentage Investigative Site #9205

Antalya, 07025

Turkey (Türkiye)

Ascentage Investigative Site #9203

Istanbul, 34381

Turkey (Türkiye)

Ascentage Investigative Site #9202

Izmir, 35100

Turkey (Türkiye)

Ascentage Investigative Site #9211

Kayseri, 38039

Turkey (Türkiye)

Ascentage Investigative Site #9208

Mersin, 33200

Turkey (Türkiye)

Ascentage Investigative Site #9220

Samsun, 55139

Turkey (Türkiye)

Ascentage Investigative Site #9210

Tekirdağ, 59030

Turkey (Türkiye)

Ascentage Investigative Site #7002

Birmingham, B15 2GW

United Kingdom

Ascentage Investigative Site #7034

Glasgow, G12 0YN

United Kingdom

Ascentage Investigative Site #7019

London, SW3 6JJ

United Kingdom