RecruitingPhase 3NCT06051409

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

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

Sponsor

Ascentage Pharma Group Inc.

Enrollment

350 participants

Start Date

Aug 31, 2023

Study Type

INTERVENTIONAL

Conditions

Ph+ ALL Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a targeted cancer drug called olverembatinib in patients newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL), a type of blood cancer linked to a specific genetic mutation. The drug targets the abnormal protein driving the cancer. **You may be eligible if...** - You have been newly diagnosed with Ph+ALL confirmed by the WHO 2016 criteria - You have adequate organ function and are in reasonable overall health - Your life expectancy is at least 3 months - You agree to use effective contraception during and after the study - Women of childbearing age must have a negative pregnancy test before starting **You may NOT be eligible if...** - You have a history of chronic myeloid leukemia - You have significant heart, liver, or kidney problems - You have active, uncontrolled infections - You are pregnant or breastfeeding 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGOlverembatinib

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

DRUGInvestigator'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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06051409