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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
Where Is This Study? (3 UK sites)
Ascentage Investigative Site #7002
Birmingham B15 2GW, United Kingdom
Ascentage Investigative Site #7034
Glasgow G12 0YN, United Kingdom
Ascentage Investigative Site #7019
London SW3 6JJ, United Kingdom
How to Get in Touch
Ascentage Clinical Operations
Sponsor contactCONTACT
