NCT06051409 · Ascentage Pharma Group Inc.
A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)
What this study is about
A global conducted at multiple hospitals, where both patients and doctors know the treatment given, randomly assigned and registrational Phase 3 study to evaluate effectiveness 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).
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)
- Expected survival of at least 3 months
- 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
Where
- Birmingham, Alabama
- Duarte, California
- Los Angeles, California
- Miami, Florida
- Augusta, Georgia
- Indianapolis, Indiana
- Lexington, Kentucky
- Hackensack, New Jersey
- New Brunswick, New Jersey
- Stony Brook, New York
- The Bronx, New York
- Houston, Texas
And 2 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 30, 2026 · Source of record for eligibility and locations