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RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for people newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), a type of blood cancer. It compares olverembatinib plus chemotherapy with a doctor-chosen targeted cancer drug plus chemotherapy to see how well and how safely they work.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You have newly diagnosed Ph+ ALL.
  • You are expected to live at least 3 months.
  • You can care for yourself and are out of bed or a chair for at least half of your waking hours (ECOG score of 0–2).
  • Your organs work well enough for the study.

Who can't join

  • You have had chronic myeloid leukemia (another blood cancer), or another cancer within 2 years.
  • You have signs of leukemia in your brain or spinal cord, or ALL outside your bone marrow, except swollen lymph nodes or an enlarged liver or spleen. Past or current brain or spinal cord disease, or an immune disease that may affect these areas, also excludes you.
  • You take treatment-level doses of blood thinners; low doses are allowed. You use banned drugs or drugs that can affect the heart's electrical rhythm. Certain drugs that interact with the study drug are also excluded if taken shortly before starting it.
  • You have uncontrolled heart disease, a blood clot in a vein within 6 months before study group assignment, or a bleeding disorder not caused by ALL.
  • You have an active infection needing treatment throughout the body, a serious problem swallowing or absorbing medicines, or an active stomach or intestinal ulcer.
  • You cannot safely take steroid medicines called glucocorticoids, are allergic to study drug ingredients or similar drugs, or plan to have major surgery.
  • You are pregnant, breastfeeding, or expect to become pregnant during the study.
  • You have an unstable illness or another condition that could make the study unsafe, keep you from following study instructions, or affect the study results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (16)

AL

CA

FL

GA

IN

KY

NJ

NY

TX

WA

WV