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

April 24, 2026 updated by: Ascentage Pharma Group Inc.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

350

Phase

Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Ascentage Clinical Operations
Phone Number: 301-291-5658
Email: clinical-trials@ascentage.com

Study Locations

Australia
- New South Wales
  - St Leonards, New South Wales, Australia
    - Active, not recruiting
    - Royal North Shore Hospital
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Active, not recruiting
    - Royal Adelaide Hospital
- Victoria
  - Melbourne, Victoria, Australia, 3004
    - Active, not recruiting
    - Alfred Health
- Washington
  - Perth, Washington, Australia, 6000
    - Active, not recruiting
    - Royal Perth Hospital
China
- Anhui
  - Bengbu, Anhui, China, 233000
    - Not yet recruiting
    - The First Affiliated Hospital of Bengbu Medical School
    - Contact:
      
      Yanli Yang, M.D.
    - Principal Investigator:
      
      Yanli Yang, M.D.
- Chongqing Municipality
  - Chongqing, Chongqing Municipality, China, 214426
    - Recruiting
    - Xinqiao Hospital of Army Medical University
    - Contact:
      
      Cheng Zhang, M.D.
    - Principal Investigator:
      
      Cheng Zhang, M.D.
- Guangzhou
  - Guangdong, Guangzhou, China, 510080
    - Recruiting
    - Guangdong Province People's Hospital
    - Contact:
      
      Jianyu Weng, M.D.
    - Principal Investigator:
      
      Jianyu Weng, M.D.
  - Guangdong, Guangzhou, China, 510515
    - Recruiting
    - Nanfang Hospital of Southern Medical University
    - Contact:
      
      Hongsheng Zhou, M.D.
    - Principal Investigator:
      
      Hongsheng Zhou, M.D.
- Henan
  - Zhengzhou, Henan, China, 450003
    - Recruiting
    - Henan Cancer Hospital
    - Contact:
      
      Xudong Wei, M.D.
    - Principal Investigator:
      
      Xudong Wei, M.D.
- Hubei
  - Wuhan, Hubei, China, 430022
    - Recruiting
    - Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
    - Contact:
      
      Mei Hong, M.D.
    - Principal Investigator:
      
      Mei Hong, M.D.
- Jiangsu
  - Suzhou, Jiangsu, China, 215006
    - Recruiting
    - The first affiliated hospital of suzhou University
    - Contact:
      
      Suning Chen, M.D.,Ph.D.
    - Principal Investigator:
      
      Suning Chen, M.D.,Ph.D.
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 200025
    - Not yet recruiting
    - Shanghai Jiao Tong University School of Medicine Ruijin Hospital
    - Contact:
      
      Weili Zhao, M.D.,Ph.D.
    - Principal Investigator:
      
      Weili Zhao, M.D.,Ph.D.
- Sichuan
  - Chengdu, Sichuan, China, 610044
    - Recruiting
    - West China Hospital of Sichuan University
    - Contact:
      
      Yu Wu, M.D.
    - Principal Investigator:
      
      Yu Wu, M.D.
- Tianjin Municipality
  - Tianjin, Tianjin Municipality, China, 215127
    - Recruiting
    - Institute of Blood Transfusion of Chinese Academy of Medical Sciences
    - Contact:
      
      Ying Wang, M.D.
    - Principal Investigator:
      
      Ying Wang, M.D.
Czechia
- - Brno, Czechia, 62500
    - Not yet recruiting
    - Ascentage Investigative Site #8647
  - Hradec Králové, Czechia, 50005
    - Not yet recruiting
    - Ascentage Investigative Site #6305
  - Ostrava, Czechia, 70852
    - Not yet recruiting
    - Ascentage Investigative Site #6304
  - Prague, Czechia, 10034
    - Not yet recruiting
    - Ascentage Investigative Site #6302
  - Prague, Czechia, 12800
    - Not yet recruiting
    - Ascentage Investigative Site #6309
France
- - Le Chesnay, France, 78150
    - Not yet recruiting
    - Ascentage Investigative Site #5020
  - Lyon, France, 69008
    - Not yet recruiting
    - Ascentage Investigative Site #5021
  - Nantes, France, 44000
    - Not yet recruiting
    - Ascentage Investigative Site #5013
  - Nice, France, 06200
    - Not yet recruiting
    - Ascentage Investigative Site #5025
  - Pessac, France, 33604
    - Not yet recruiting
    - Ascentage Investigative Site #5019
  - Pierre-Bénite, France, 69495
    - Not yet recruiting
    - Ascentage Investigative Site #5024
  - Poitiers, France, 86021
    - Not yet recruiting
    - Ascentage Investigative Site #5022
  - Toulouse, France, 31059
    - Not yet recruiting
    - Ascentage Investigative Site #5018
Italy
- - Bologna, Italy, 40138
    - Not yet recruiting
    - Ascentage Investigative Site #5538
  - Meldola, Italy, 47014
    - Not yet recruiting
    - Ascentage Investigative Site #5529
  - Milan, Italy, 20132
    - Not yet recruiting
    - Ascentage Investigative Site #5539
  - Monza, Italy, 20900
    - Not yet recruiting
    - Ascentage Investigative Site #5533
  - Ravenna, Italy, 48121
    - Not yet recruiting
    - Ascentage Investigative Site #5540
  - Roma, Italy, 00138
    - Not yet recruiting
    - Ascentage Investigative Site #5531
  - Torino, Italy, 10126
    - Not yet recruiting
    - Ascentage Investigative Site #5550
  - Varese, Italy, 21100
    - Not yet recruiting
    - Ascentage Investigative Site #5536
Romania
- - Bucharest, Romania, 020125
    - Not yet recruiting
    - Ascentage Investigative Site #6503
  - Cluj-Napoca, Romania, 400015
    - Not yet recruiting
    - Ascentage Investigative Site #6502
  - Craiova, Romania, 200143
    - Not yet recruiting
    - Ascentage Investigative Site #6507
  - Iași, Romania, 700483
    - Not yet recruiting
    - Ascentage Investigative Site #6504
Singapore
- - Singapore, Singapore, 119074
    - Not yet recruiting
    - Ascentage Investigative Site #6602
  - Singapore, Singapore, 169608
    - Not yet recruiting
    - Ascentage Investigative Site #6603
  - Singapore, Singapore, 308433
    - Not yet recruiting
    - Ascentage Investigative Site #6604
South Korea
- - Busan, South Korea, 49201
    - Not yet recruiting
    - Ascentage Investigative Site #8206
  - Busan, South Korea, 49241
    - Not yet recruiting
    - Ascentage Investigative Site #8207
  - Seoul, South Korea, 03080
    - Not yet recruiting
    - Ascentage Investigative Site #8201
  - Seoul, South Korea, 05505
    - Not yet recruiting
    - Ascentage Investigative Site #8202
  - Seoul, South Korea, 06591
    - Not yet recruiting
    - Ascentage Investigative Site #8203
  - Uijeongbu-si, South Korea, 11759
    - Not yet recruiting
    - Ascentage Investigative Site #8208
Spain
- - Badalona, Spain, 08916
    - Not yet recruiting
    - Ascentage Investigative Site #6018
  - Badalona, Spain, 08916
    - Not yet recruiting
    - Ascentage Investigative Site #6019
  - Barcelona, Spain, 08035
    - Not yet recruiting
    - Ascentage Investigative Site #6020
  - Cáceres, Spain, 10003
    - Not yet recruiting
    - Ascentage Investigative Site #6048
  - Madrid, Spain, 20834
    - Not yet recruiting
    - Ascentage Investigative Site #6016
  - Madrid, Spain, 20840
    - Not yet recruiting
    - Ascentage Investigative Site #6049
  - Madrid, Spain, 28006
    - Not yet recruiting
    - Ascentage Investigative Site #6035
  - Madrid, Spain, 28007
    - Not yet recruiting
    - Ascentage Investigative Site #6013
  - Madrid, Spain, 28041
    - Not yet recruiting
    - Ascentage Investigative Site #6011
  - Santander, Spain, 39008
    - Not yet recruiting
    - Ascentage Investigative Site #6021
  - Seville, Spain, 41010
    - Not yet recruiting
    - Ascentage Investigative Site #6050
  - Valencia, Spain, 6017
    - Not yet recruiting
    - Ascentage Investigative Site #6017
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06100
    - Not yet recruiting
    - Ascentage Investigative Site #9201
  - Ankara, Turkey (Türkiye), 06170
    - Not yet recruiting
    - Ascentage Investigative Site #9204
  - Ankara, Turkey (Türkiye), 06200
    - Not yet recruiting
    - Ascentage Investigative Site #9212
  - Ankara, Turkey (Türkiye), 06560
    - Not yet recruiting
    - Ascentage Investigative Site #9209
  - Antalya, Turkey (Türkiye), 07025
    - Not yet recruiting
    - Ascentage Investigative Site #9205
  - Istanbul, Turkey (Türkiye), 34381
    - Not yet recruiting
    - Ascentage Investigative Site #9203
  - Izmir, Turkey (Türkiye), 35100
    - Not yet recruiting
    - Ascentage Investigative Site #9202
  - Kayseri, Turkey (Türkiye), 38039
    - Not yet recruiting
    - Ascentage Investigative Site #9211
  - Mersin, Turkey (Türkiye), 33200
    - Not yet recruiting
    - Ascentage Investigative Site #9208
  - Samsun, Turkey (Türkiye), 55139
    - Not yet recruiting
    - Ascentage Investigative Site #9220
  - Tekirdağ, Turkey (Türkiye), 59030
    - Not yet recruiting
    - Ascentage Investigative Site #9210
United Kingdom
- - Birmingham, United Kingdom, B15 2GW
    - Not yet recruiting
    - Ascentage Investigative Site #7002
  - Glasgow, United Kingdom, G12 0YN
    - Not yet recruiting
    - Ascentage Investigative Site #7034
  - London, United Kingdom, SW3 6JJ
    - Not yet recruiting
    - Ascentage Investigative Site #7019
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - Not yet recruiting
    - Ascentage Investigative Site #1044
- California
  - Duarte, California, United States, 91010
    - Not yet recruiting
    - Ascentage Investigative Site #1062
  - Los Angeles, California, United States, 90048
    - Not yet recruiting
    - Ascentage Investigative Site #1134
  - Los Angeles, California, United States, 90095
    - Not yet recruiting
    - Ascentage Investigative Site #1059
- Florida
  - Miami, Florida, United States, 33155
    - Not yet recruiting
    - Ascentage Investigative Site #1142
- Georgia
  - Augusta, Georgia, United States, 30912
    - Not yet recruiting
    - Ascentage Investigative Site #1045
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Not yet recruiting
    - Ascentage Investigative Site #1158
  - Indianapolis, Indiana, United States, 46237
    - Not yet recruiting
    - Ascentage Investigative Site #1069
- Kentucky
  - Lexington, Kentucky, United States, 40536
    - Not yet recruiting
    - Ascentage Investigative Site #1084
- New Jersey
  - Hackensack, New Jersey, United States, 07601
    - Not yet recruiting
    - Ascentage Investigative Site #1064
  - New Brunswick, New Jersey, United States, 08901
    - Not yet recruiting
    - Ascentage Investigative Site #1098
- New York
  - Stony Brook, New York, United States, 11794
    - Not yet recruiting
    - Ascentage Investigative Site #1160
  - The Bronx, New York, United States, 10461
    - Not yet recruiting
    - Ascentage Investigative Site #1151
- Texas
  - Houston, Texas, United States, 77030
    - Not yet recruiting
    - Ascentage Investigative Site #1501
- Washington
  - Seattle, Washington, United States, 98104
    - Not yet recruiting
    - Ascentage Investigative Site #1806
- West Virginia
  - Morgantown, West Virginia, United States, 26506
    - Not yet recruiting
    - Ascentage Investigative Site #1155

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)
Expected survival of at least 3 months
ECOG ≤ 2
Adequate organ function

Exclusion Criteria:

A history of chronic myeloid leukemia (CML)
Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly
Previous or current clinical CNS diseases
Autoimmune diseases that may involve the CNS
Use of therapeutic doses of anticoagulants and/or antiplatelet agents; low doses of anticoagulants or antiplatelet agents are allowed
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
Uncontrolled heart diseases
Any venous thromboembolism in the 6 months prior to randomization, including but not limited to deep vein thrombosis (DVT) or pulmonary embolism
Use of prohibited drugs
Disease or medical condition that is unstable or may affect its safety or compliance with the study
Use of medications known to cause prolonged QT interval
Active infections requiring systemic treatment
Disease that severely affects the oral administration and absorption of drugs, or an active gastrointestinal ulcer
Contraindications to the use of glucocorticoids
Bleeding disorders unrelated to ALL
Plan to undergo major surgery
Allergy to drug ingredients, excipients, or their analogues in the study
Female subjects who are pregnant or breastfeeding or expect to become pregnant during the study period
Other malignant tumors within 2 years
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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Olverembatinib Olverembatinib in combination with chemotherapy	Drug: Olverembatinib Oral (PO) once every other day (QOD).
Active Comparator: Investigator's choice of TKI Investigator's choice of TKI in combination with chemotherapy	Drug: Investigator's choice of TKI Oral (PO) once daily (QD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal Residual Disease Negative CR Rate Time Frame: Cycle 1 to Cycle 3 (each cycle is 28 days)	The minimal residual disease negative CR rate of olverembatinib combined with chemotherapy versus investigator's choice of TKI combined with chemotherapy in subjects with newly diagnosed Ph+ALL.	Cycle 1 to Cycle 3 (each cycle is 28 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentrations of olverembatinib Time Frame: Cycle 1 to Cycle 3 (each cycle is 28 days)	Blood samples will be collected to measure the plasma concentration of olverembatinib.	Cycle 1 to Cycle 3 (each cycle is 28 days)
Event-free Survival (EFS) Time Frame: Baseline up to 3 to 6 years	EFS is defined as the time from study randomization to the date of treatment failure (ITF), relapse from CR, or death from any cause, whichever comes first.	Baseline up to 3 to 6 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. Time Frame: Through study completion (approximately 2 years)	According to CTCAE v5.0, the number and frequency of adverse events of test drug will be assessed.	Through study completion (approximately 2 years)
FACT-Leu (Functional Assessment of Cancer Therapy - Leukemia) Score Time Frame: Through study completion (approximately 2 years)	To evaluate health-related Quality of Life (HR-QoL) in patients treated with olverembatinib plus chemotherapy.	Through study completion (approximately 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascentage Pharma Group Inc.

Collaborators

Guangzhou Healthquest Pharma Co., Ltd

Investigators

Principal Investigator: Elias Jabbour, M.D., M.D. Anderson Cancer Center
Principal Investigator: Weili Zhao, M.D., Ph.D., Shanghai Jiaotong University School of Medicine Ruijin Hospital
Principal Investigator: Suning Chen, M.D., Ph.D., First Affiliated Hospital of Suzhou Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 17, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

HQP1351AG301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Expanded Access

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

Clinical Trials on Olverembatinib

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