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Taking peoplePhase 3

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
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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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