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Looking for participantsPhase3

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

Sponsor: Ascentage Pharma Group Inc.

NCT ID: NCT06051409

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Olverembatinib (drug), Investigator's choice of TKI (drug)
How long the study runs
Study runs about 70 months (dates as stated)
About the drug or intervention
Olverembatinib — drug: Oral (PO) once every other day (QOD). · Investigator's choice of TKI — drug: Oral (PO) once daily (QD).
Patient visit burden
Not specified by the sponsor

In plain English

This study, called POLARIS-1, is testing a medicine called olverembatinib in people who have just been told they have a type of blood cancer called Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL). The study is paid for by Ascentage Pharma Group Inc.

Who can take part

  • Newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL)
  • Expected to live at least 3 more months
  • Able to carry out light daily activity (performance score of 2 or better on a scale called ECOG)
  • Organs such as the liver and kidneys are working well enough

Who may not be able to

  • Past or current chronic myeloid leukaemia (CML)
  • Signs that the leukaemia has spread to the brain or spinal cord, or to tissues outside the bone marrow (apart from swollen lymph nodes or an enlarged liver or spleen)
  • Past or current brain or spinal cord illnesses
  • Autoimmune illnesses that could affect the brain or spinal cord
  • Taking full-dose blood-thinning or anti-clotting medicines (low doses are allowed)
  • Taking a medicine that could interact with the study drug shortly before starting
  • Heart problems that are not under control
  • A blood clot, such as in a deep vein or the lung, in the past 6 months
  • Taking medicines that are not allowed in this study
  • Any other illness that is unstable or could affect safety or taking part properly
  • Taking medicines known to affect the heart's electrical rhythm (QT interval)
  • An infection needing treatment that affects the whole body
  • Stomach or gut problems that make it hard to swallow or absorb tablets, or an active stomach ulcer
  • Not being able to take steroid medicines
  • Bleeding problems not caused by the leukaemia
  • Planning major surgery
  • Allergy to any ingredients of the study drug or similar medicines
  • Being pregnant, breastfeeding, or planning to become pregnant during the study
  • Another cancer within the past 2 years
  • Any other problem that could make the study results hard to read or make taking part unsafe

What taking part involves

  • • Taking the study medicine olverembatinib, which is swallowed as a tablet
  • • Attend study visits for check-ups and tests — details of the schedule are not stated — ask the trial team

Time commitment: Not stated — ask the trial team about how long the study lasts, how many visits are needed, and what tests are involved.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
350
Started
2023-08-31
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for ph+ all
  • • Phase3 - 350 participants
  • • 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 take part?

  • • Ages 18 Years and over
  • • Diagnosed with ph+ all

Where?

  • • Birmingham - Ascentage Investigative Site #7002
  • • Glasgow - Ascentage Investigative Site #7034
  • • London - Ascentage Investigative Site #7019

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

More detail

Comparing efficacy and safety of olverembatinib in combination with chemotherapy (investigational arm) vs. investigator's choice of TKI in combination with chemotherapy (control arm).

Ph+ ALLLeukemia, Lymphoblastic, Acute, Philadelphia-Positive

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders
  • How fit you need to be: ECOG 2 or better

What the study is looking for

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

Who cannot take part

  • ✗A history of chronic myeloid leukemia (CML)
  • ✗Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except...
  • ✗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...
See the full criteria
Inclusion Criteria: 1. Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL) 2. Expected survival of at least 3 months 3. ECOG ≤ 2 4. Adequate organ function Exclusion Criteria: 1. A history of chronic myeloid leukemia (CML) 2. Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly 3. Previous or current clinical CNS diseases 4. Autoimmune diseases that may involve the CNS 5. Use of therapeutic doses of anticoagulants and/or antiplatelet agents; low doses of anticoagulants or antiplatelet agents are allowed 6. 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 7. Uncontrolled heart diseases 8. Any venous thromboembolism in the 6 months prior to randomization, including but not limited to deep vein thrombosis (DVT) or pulmonary embolism 9. Use of prohibited drugs 10. Disease or medical condition that is unstable or may affect its safety or compliance with the study 11. Use of medications known to cause prolonged QT interval 12. Active infections requiring systemic treatment 13. Disease that severely affects the oral administration and absorption of drugs, or an active gastrointestinal ulcer 14. Contraindications to the use of glucocorticoids 15. Bleeding disorders unrelated to ALL 16. Plan to undergo major surgery 17. Allergy to drug ingredients, excipients, or their analogues in the study 18. Female subjects who are pregnant or breastfeeding or expect to become pregnant during the study period 19. Other malignant tumors within 2 years 20. 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 Is This Study? (3 UK sites)

Ascentage Investigative Site #7002

Birmingham B15 2GW, United Kingdom

NOT_YET_RECRUITING

Ascentage Investigative Site #7034

Glasgow G12 0YN, United Kingdom

NOT_YET_RECRUITING

Ascentage Investigative Site #7019

London SW3 6JJ, United Kingdom

NOT_YET_RECRUITING

How to Get in Touch

Ascentage Clinical Operations

Sponsor contact

CONTACT

301-291-5658 clinical-trials@ascentage.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-04