Tests olverembatinib with chemotherapy in newly diagnosed Ph+ ALL
Tests olverembatinib plus chemotherapy in adults newly diagnosed with Ph+ acute lymphoblastic leukemia.
Key facts
- Who runs it
- Ascentage Pharma Group Inc.
- Where
- Birmingham, Glasgow, and London, United KingdomSee the 3 sitesAlso in 15 other countries, 97 sites
- Trial code
- Registry title
- A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 350 people, planned
- Started
- 31 Aug 2023
- Expected to end
- 30 Jun 2029
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Olverembatinib
- Investigator's choice of TKI
- Record updated
- 30 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). They will get chemotherapy with olverembatinib or with another TKI chosen by the doctor.
- Age
- 18 years or older
- Sex
- Women and men can both join.
- Disease stage
- Newly diagnosed Ph+ ALL. Expected survival of at least 3 months. ECOG 2 or lower. Adequate organ function.
- Biomarker or test result
- Philadelphia chromosome-positive (Ph+) leukemia
Main reasons for not taking part
- History of chronic myeloid leukemia (CML)
- Signs of leukemia in the central nervous system (CNS), or other CNS disease
- Uncontrolled heart disease, or a blood clot in the 6 months before randomization
- Active infection that needs treatment through the body
- Pregnant or breastfeeding, or expecting to become pregnant during the study
The registry criteria, word for word
Show all 24 criteriaShow less
Who can take part
- Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)
- Expected survival of at least 3 months
- ECOG ≤ 2
- Adequate organ function
Who cannot take part
- Previous or current clinical CNS diseases
- 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
- 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
- Plan to undergo major surgery
- 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
- A history of chronic myeloid leukemia (CML)
- Autoimmune diseases that may involve the CNS
- Uncontrolled heart diseases
- Disease or medical condition that is unstable or may affect its safety or compliance with the study
- Active infections requiring systemic treatment
- Disease that severely affects the oral administration and absorption of drugs, or an active gastrointestinal ulcer
- Bleeding disorders unrelated to ALL
- Allergy to drug ingredients, excipients, or their analogues in the study
- Other malignant tumors within 2 years
- Use of medications known to cause prolonged QT interval
- Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly
- Use of therapeutic doses of anticoagulants and/or antiplatelet agents; low doses of anticoagulants or antiplatelet agents are allowed
- Contraindications to the use of glucocorticoids
- Female subjects who are pregnant or breastfeeding or expect to become pregnant during the study period
Where in United Kingdom
Also in 15 other countries, 97 sites
- BirminghamHospital not named in the registryContact: Ascentage Clinical OperationsNot yet recruiting
- GlasgowHospital not named in the registryContact: Ascentage Clinical OperationsNot yet recruiting
- LondonHospital not named in the registryContact: Ascentage Clinical OperationsNot yet recruiting
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- OlverembatinibTreatment being tested
Olverembatinib in combination with chemotherapy
- Investigator's choice of TKIExisting treatment, for comparison
Investigator's choice of TKI in combination with chemotherapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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
- Plain-language title
- Tests olverembatinib with chemotherapy in newly diagnosed Ph+ ALLGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 30 April 2026