Ph+ ALLPhase 3NCT06051409

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

A Phase 3 study testing Olverembatinib and Investigator's choice of TKI in people with Ph+ ALL and Leukemia, Lymphoblastic, Acute, Philadelphia-Positive, run by Ascentage Pharma Group Inc. at 90 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ph+ ALL, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
What is being tested?: Olverembatinib and Investigator's choice of TKI
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 350 participants
Where: 90 sitesin 12 countries
Study dates: 31 Aug 2023to 30 Jun 2029
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 20Show fewer

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

Trial locations and contacts

90 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Ascentage Clinical Operations contact

301-291-5658

clinical-trials@ascentage.com

Country

City, postcode or hospital

Sites recruiting now only

90 sites in 12 countries

United States16 sites, 16 recruiting

Ascentage Investigative Site #1045
Augusta, Georgia, 30912
Not yet recruiting
Ascentage Investigative Site #1044
Birmingham, Alabama, 35233
Not yet recruiting
Ascentage Investigative Site #1062
Duarte, California, 91010
Not yet recruiting
Ascentage Investigative Site #1064
Hackensack, New Jersey, 07601
Not yet recruiting
Ascentage Investigative Site #1501
Houston, Texas, 77030
Not yet recruiting
Ascentage Investigative Site #1158
Indianapolis, Indiana, 46202
Not yet recruiting
Ascentage Investigative Site #1069
Indianapolis, Indiana, 46237
Not yet recruiting
Ascentage Investigative Site #1084
Lexington, Kentucky, 40536
Not yet recruiting
Ascentage Investigative Site #1134
Los Angeles, California, 90048
Not yet recruiting
Ascentage Investigative Site #1059
Los Angeles, California, 90095
Not yet recruiting
Ascentage Investigative Site #1142
Miami, Florida, 33155
Not yet recruiting
Ascentage Investigative Site #1155
Morgantown, West Virginia, 26506
Not yet recruiting
Ascentage Investigative Site #1098
New Brunswick, New Jersey, 08901
Not yet recruiting
Ascentage Investigative Site #1806
Seattle, Washington, 98104
Not yet recruiting
Ascentage Investigative Site #1160
Stony Brook, New York, 11794
Not yet recruiting
Ascentage Investigative Site #1151
The Bronx, New York, 10461
Not yet recruiting

Other trials in United States

Spain12 sites, 12 recruiting

Ascentage Investigative Site #6018
Badalona, 08916
Not yet recruiting
Ascentage Investigative Site #6019
Badalona, 08916
Not yet recruiting
Ascentage Investigative Site #6020
Barcelona, 08035
Not yet recruiting
Ascentage Investigative Site #6048
Cáceres, 10003
Not yet recruiting
Ascentage Investigative Site #6016
Madrid, 20834
Not yet recruiting
Ascentage Investigative Site #6049
Madrid, 20840
Not yet recruiting
Ascentage Investigative Site #6035
Madrid, 28006
Not yet recruiting
Ascentage Investigative Site #6013
Madrid, 28007
Not yet recruiting
Ascentage Investigative Site #6011
Madrid, 28041
Not yet recruiting
Ascentage Investigative Site #6021
Santander, 39008
Not yet recruiting
Ascentage Investigative Site #6050
Seville, 41010
Not yet recruiting
Ascentage Investigative Site #6017
Valencia, 6017
Not yet recruiting

Other trials in Spain

Turkey (Türkiye)11 sites, 11 recruiting

Ascentage Investigative Site #9201
Ankara, 06100
Not yet recruiting
Ascentage Investigative Site #9204
Ankara, 06170
Not yet recruiting
Ascentage Investigative Site #9212
Ankara, 06200
Not yet recruiting
Ascentage Investigative Site #9209
Ankara, 06560
Not yet recruiting
Ascentage Investigative Site #9205
Antalya, 07025
Not yet recruiting
Ascentage Investigative Site #9203
Istanbul, 34381
Not yet recruiting
Ascentage Investigative Site #9202
Izmir, 35100
Not yet recruiting
Ascentage Investigative Site #9211
Kayseri, 38039
Not yet recruiting
Ascentage Investigative Site #9208
Mersin, 33200
Not yet recruiting
Ascentage Investigative Site #9220
Samsun, 55139
Not yet recruiting
Ascentage Investigative Site #9210
Tekirdağ, 59030
Not yet recruiting

Other trials in Turkey (Türkiye)

China10 sites, 10 recruiting

The First Affiliated Hospital of Bengbu Medical School
Bengbu, Anhui, 233000
Yanli Yang, M.D.
Yanli Yang, M.D.
Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
Yu Wu, M.D.
Yu Wu, M.D.
Recruiting
Xinqiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, 214426
Cheng Zhang, M.D.
Cheng Zhang, M.D.
Recruiting
Guangdong Province People's Hospital
Guangdong, Guangzhou, 510080
Jianyu Weng, M.D.
Jianyu Weng, M.D.
Recruiting
Nanfang Hospital of Southern Medical University
Guangdong, Guangzhou, 510515
Hongsheng Zhou, M.D.
Hongsheng Zhou, M.D.
Recruiting
Shanghai Jiao Tong University School of Medicine Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Weili Zhao, M.D.,Ph.D.
Weili Zhao, M.D.,Ph.D.
Not yet recruiting
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, 215006
Suning Chen, M.D.,Ph.D.
Suning Chen, M.D.,Ph.D.
Recruiting
Institute of Blood Transfusion of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 215127
Ying Wang, M.D.
Ying Wang, M.D.
Recruiting
Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Mei Hong, M.D.
Mei Hong, M.D.
Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Xudong Wei, M.D.
Xudong Wei, M.D.
Recruiting

Other trials in China

France8 sites, 8 recruiting

Ascentage Investigative Site #5020
Le Chesnay, 78150
Not yet recruiting
Ascentage Investigative Site #5021
Lyon, 69008
Not yet recruiting
Ascentage Investigative Site #5013
Nantes, 44000
Not yet recruiting
Ascentage Investigative Site #5025
Nice, 06200
Not yet recruiting
Ascentage Investigative Site #5019
Pessac, 33604
Not yet recruiting
Ascentage Investigative Site #5024
Pierre-Bénite, 69495
Not yet recruiting
Ascentage Investigative Site #5022
Poitiers, 86021
Not yet recruiting
Ascentage Investigative Site #5018
Toulouse, 31059
Not yet recruiting

Other trials in France

Italy8 sites, 8 recruiting

Ascentage Investigative Site #5538
Bologna, 40138
Not yet recruiting
Ascentage Investigative Site #5529
Meldola, 47014
Not yet recruiting
Ascentage Investigative Site #5539
Milan, 20132
Not yet recruiting
Ascentage Investigative Site #5533
Monza, 20900
Not yet recruiting
Ascentage Investigative Site #5540
Ravenna, 48121
Not yet recruiting
Ascentage Investigative Site #5531
Roma, 00138
Not yet recruiting
Ascentage Investigative Site #5550
Torino, 10126
Not yet recruiting
Ascentage Investigative Site #5536
Varese, 21100
Not yet recruiting

Other trials in Italy

South Korea6 sites, 6 recruiting

Ascentage Investigative Site #8206
Busan, 49201
Not yet recruiting
Ascentage Investigative Site #8207
Busan, 49241
Not yet recruiting
Ascentage Investigative Site #8201
Seoul, 03080
Not yet recruiting
Ascentage Investigative Site #8202
Seoul, 05505
Not yet recruiting
Ascentage Investigative Site #8203
Seoul, 06591
Not yet recruiting
Ascentage Investigative Site #8208
Uijeongbu-si, 11759
Not yet recruiting

Other trials in South Korea

Czechia5 sites, 5 recruiting

Ascentage Investigative Site #8647
Brno, 62500
Not yet recruiting
Ascentage Investigative Site #6305
Hradec Králové, 50005
Not yet recruiting
Ascentage Investigative Site #6304
Ostrava, 70852
Not yet recruiting
Ascentage Investigative Site #6302
Prague, 10034
Not yet recruiting
Ascentage Investigative Site #6309
Prague, 12800
Not yet recruiting

Other trials in Czechia

Australia4 sites

Royal Adelaide Hospital
Adelaide, South Australia, 5000
Active, not recruiting
Alfred Health
Melbourne, Victoria, 3004
Active, not recruiting
Royal Perth Hospital
Perth, Washington, 6000
Active, not recruiting
Royal North Shore Hospital
St Leonards, New South Wales
Active, not recruiting

Other trials in Australia

Romania4 sites, 4 recruiting

Ascentage Investigative Site #6503
Bucharest, 020125
Not yet recruiting
Ascentage Investigative Site #6502
Cluj-Napoca, 400015
Not yet recruiting
Ascentage Investigative Site #6507
Craiova, 200143
Not yet recruiting
Ascentage Investigative Site #6504
Iași, 700483
Not yet recruiting

Other trials in Romania

Singapore3 sites, 3 recruiting

Ascentage Investigative Site #6602
Singapore, 119074
Not yet recruiting
Ascentage Investigative Site #6603
Singapore, 169608
Not yet recruiting
Ascentage Investigative Site #6604
Singapore, 308433
Not yet recruiting

Other trials in Singapore

United Kingdom3 sites, 3 recruiting

Ascentage Investigative Site #7002
Birmingham, B15 2GW
Not yet recruiting
Ascentage Investigative Site #7034
Glasgow, G12 0YN
Not yet recruiting
Ascentage Investigative Site #7019
London, SW3 6JJ
Not yet recruiting

Other trials in United Kingdom

About this study

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

Read the 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).

Conditions: Ph+ ALL, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Being tested: Olverembatinib, Investigator's choice of TKI
Keywords: Ph+ ALL, Olverembatinib, Acute lymphoblastic leukemia, Bcr-Abl Tyrosine Kinase
Medical subject headings: Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OlverembatinibDrug
Oral (PO) once every other day (QOD).
Investigator's choice of TKIDrug
Oral (PO) once daily (QD).

Study groups in NCT06051409
Study group	Role	What they receive
Olverembatinib	Experimental	Olverembatinib in combination with chemotherapy Receives: Drug: Olverembatinib
Investigator's choice of TKI	Active comparator	Investigator's choice of TKI in combination with chemotherapy Receives: Drug: Investigator's choice of TKI

What is being measured

The primary outcome is the main question the study is designed to answer.

Minimal Residual Disease Negative CR Rate
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.
Measured: Cycle 1 to Cycle 3 (each cycle is 28 days)

Secondary outcomes (4)

Event-free Survival (EFS)
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.
Measured: Baseline up to 3 to 6 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
According to CTCAE v5.0, the number and frequency of adverse events of test drug will be assessed.
Measured: Through study completion (approximately 2 years)
Plasma concentrations of olverembatinib
Blood samples will be collected to measure the plasma concentration of olverembatinib.
Measured: Cycle 1 to Cycle 3 (each cycle is 28 days)
FACT-Leu (Functional Assessment of Cancer Therapy - Leukemia) Score
To evaluate health-related Quality of Life (HR-QoL) in patients treated with olverembatinib plus chemotherapy.
Measured: Through study completion (approximately 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Aug 202330 Jun 2029

First posted22 Sep 2023
Study start31 Aug 2023
Primary completion31 Dec 2027 (estimated)
Study completion30 Jun 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ph+ ALLStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 350 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06051409
Sponsor's protocol ID: HQP1351AG301
Status last verified: Apr 2026
First submitted: 4 Sep 2023
Last updated: 30 Apr 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Expanded access: Available

Interested in taking part?

Ascentage Clinical Operations

301-291-5658

clinical-trials@ascentage.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia
Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Not yet recruitingPhase 2
Immuno-Targeted Therapy Plus Low-Dose Chemotherapy for Newly Diagnosed Adult Ph-Negative B-ALL: A Prospective Umbrella Trial
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