Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06051409
PHASE3

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

Sponsor: Ascentage Pharma Group Inc.

View on ClinicalTrials.gov

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).

Official title: A Pivotal Registrational Phase 3 Study of Olverembatinib Combined With Chemotherapy Versus Investigator's Choice of TKI Combined With Chemotherapy in Patients With Newly Diagnosed Ph+ ALL

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2023-08-31

Completion Date

2029-06-30

Last Updated

2026-04-30

Healthy Volunteers

No

Interventions

DRUG

Olverembatinib

Oral (PO) once every other day (QOD).

DRUG

Investigator's choice of TKI

Oral (PO) once daily (QD).

Locations (90)

Ascentage Investigative Site #1044

Birmingham, Alabama, United States

Ascentage Investigative Site #1062

Duarte, California, United States

Ascentage Investigative Site #1134

Los Angeles, California, United States

Ascentage Investigative Site #1059

Los Angeles, California, United States

Ascentage Investigative Site #1142

Miami, Florida, United States

Ascentage Investigative Site #1045

Augusta, Georgia, United States

Ascentage Investigative Site #1158

Indianapolis, Indiana, United States

Ascentage Investigative Site #1069

Indianapolis, Indiana, United States

Ascentage Investigative Site #1084

Lexington, Kentucky, United States

Ascentage Investigative Site #1064

Hackensack, New Jersey, United States

Ascentage Investigative Site #1098

New Brunswick, New Jersey, United States

Ascentage Investigative Site #1160

Stony Brook, New York, United States

Ascentage Investigative Site #1151

The Bronx, New York, United States

Ascentage Investigative Site #1501

Houston, Texas, United States

Ascentage Investigative Site #1806

Seattle, Washington, United States

Ascentage Investigative Site #1155

Morgantown, West Virginia, United States

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Alfred Health

Melbourne, Victoria, Australia

Royal Perth Hospital

Perth, Washington, Australia

The First Affiliated Hospital of Bengbu Medical School

Bengbu, Anhui, China

Xinqiao Hospital of Army Medical University

Chongqing, Chongqing Municipality, China

Guangdong Province People's Hospital

Guangdong, Guangzhou, China

Nanfang Hospital of Southern Medical University

Guangdong, Guangzhou, China

Henan Cancer Hospital

Zhengzhou, Henan, China

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

Wuhan, Hubei, China

The First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, China

Shanghai Jiao Tong University School of Medicine Ruijin Hospital

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Institute of Blood Transfusion of Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Ascentage Investigative Site #8647

Brno, Czechia

Ascentage Investigative Site #6305

Hradec Králové, Czechia

Ascentage Investigative Site #6304

Ostrava, Czechia

Ascentage Investigative Site #6302

Prague, Czechia

Ascentage Investigative Site #6309

Prague, Czechia

Ascentage Investigative Site #5020

Le Chesnay, France

Ascentage Investigative Site #5021

Lyon, France

Ascentage Investigative Site #5013

Nantes, France

Ascentage Investigative Site #5025

Nice, France

Ascentage Investigative Site #5019

Pessac, France

Ascentage Investigative Site #5024

Pierre-Bénite, France

Ascentage Investigative Site #5022

Poitiers, France

Ascentage Investigative Site #5018

Toulouse, France

Ascentage Investigative Site #5538

Bologna, Italy

Ascentage Investigative Site #5529

Meldola, Italy

Ascentage Investigative Site #5539

Milan, Italy

Ascentage Investigative Site #5533

Monza, Italy

Ascentage Investigative Site #5540

Ravenna, Italy

Ascentage Investigative Site #5531

Roma, Italy

Ascentage Investigative Site #5550

Torino, Italy

Ascentage Investigative Site #5536

Varese, Italy

Ascentage Investigative Site #6503

Bucharest, Romania

Ascentage Investigative Site #6502

Cluj-Napoca, Romania

Ascentage Investigative Site #6507

Craiova, Romania

Ascentage Investigative Site #6504

Iași, Romania

Ascentage Investigative Site #6602

Singapore, Singapore

Ascentage Investigative Site #6603

Singapore, Singapore

Ascentage Investigative Site #6604

Singapore, Singapore

Ascentage Investigative Site #8206

Busan, South Korea

Ascentage Investigative Site #8207

Busan, South Korea

Ascentage Investigative Site #8201

Seoul, South Korea

Ascentage Investigative Site #8202

Seoul, South Korea

Ascentage Investigative Site #8203

Seoul, South Korea

Ascentage Investigative Site #8208

Uijeongbu-si, South Korea

Ascentage Investigative Site #6018

Badalona, Spain

Ascentage Investigative Site #6019

Badalona, Spain

Ascentage Investigative Site #6020

Barcelona, Spain

Ascentage Investigative Site #6048

Cáceres, Spain

Ascentage Investigative Site #6016

Madrid, Spain

Ascentage Investigative Site #6049

Madrid, Spain

Ascentage Investigative Site #6035

Madrid, Spain

Ascentage Investigative Site #6013

Madrid, Spain

Ascentage Investigative Site #6011

Madrid, Spain

Ascentage Investigative Site #6021

Santander, Spain

Ascentage Investigative Site #6050

Seville, Spain

Ascentage Investigative Site #6017

Valencia, Spain

Ascentage Investigative Site #9201

Ankara, Turkey (Türkiye)

Ascentage Investigative Site #9204

Ankara, Turkey (Türkiye)

Ascentage Investigative Site #9212

Ankara, Turkey (Türkiye)

Ascentage Investigative Site #9209

Ankara, Turkey (Türkiye)

Ascentage Investigative Site #9205

Antalya, Turkey (Türkiye)

Ascentage Investigative Site #9203

Istanbul, Turkey (Türkiye)

Ascentage Investigative Site #9202

Izmir, Turkey (Türkiye)

Ascentage Investigative Site #9211

Kayseri, Turkey (Türkiye)

Ascentage Investigative Site #9208

Mersin, Turkey (Türkiye)

Ascentage Investigative Site #9220

Samsun, Turkey (Türkiye)

Ascentage Investigative Site #9210

Tekirdağ, Turkey (Türkiye)

Ascentage Investigative Site #7002

Birmingham, United Kingdom

Ascentage Investigative Site #7034

Glasgow, United Kingdom

Ascentage Investigative Site #7019

London, United Kingdom