Tests olverembatinib with chemotherapy in newly diagnosed Ph+ ALL
Tests olverembatinib plus chemotherapy in adults newly diagnosed with Ph+ acute lymphoblastic leukemia.
Plain-language title generated from the registry record
Registry title: A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)
Key facts
- Where
- Bucharest, Cluj-Napoca, Craiova, and Iași, RomaniaSee the 4 sites
- Phase
- Phase 3
Where in Romania
- Spitalul Clinic Colentina BucurestiBucharest, RomaniaTaking people
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-NapocaCluj-Napoca, RomaniaTaking people
- Spitalul Clinic Municipal Filantropia CraiovaCraiova, RomaniaTaking people
- Institutul Regional de Oncologie IasiIași, RomaniaTaking people
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?
Trial details
- Who runs it
- Ascentage Pharma Group Inc.
- Trial code
- NCT06051409EU 2024-511496-14-00
- Record updated
- 30 April 2026
- Original 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).Read full original descriptionShow less
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).
Inclusion: Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL); Expected survival of at least 3 months; ECOG ≤ 2; Adequate organ function.
Exclusion: 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.