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New treatment option for Ph+ ALL
Official title A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)
ClinicalTrials.gov ID: NCT06051409
What this study is testing
What is Olverembatinib?
Olverembatinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ph+ all.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)
- Expected survival of at least 3 months
- ECOG ≤ 2
- Adequate organ function
You likely can't join if
- A history of chronic myeloid leukemia (CML)
- Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly
- 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 agents are allowed
- 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...
See the full eligibility criteria
- Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)
- Expected survival of at least 3 months
- ECOG ≤ 2
- Adequate organ function
- A history of chronic myeloid leukemia (CML)
- Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly
- 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 agents are allowed
- 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
- Uncontrolled heart diseases
- 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
- Disease or medical condition that is unstable or may affect its safety or compliance with the study
- Use of medications known to cause prolonged QT interval
- Active infections requiring systemic treatment
- Disease that severely affects the oral administration and absorption of drugs, or an active gastrointestinal ulcer
- Contraindications to the use of glucocorticoids
- Bleeding disorders unrelated to ALL
- Plan to undergo major surgery
- Allergy to drug ingredients, excipients, or their analogues in the study
- Female people who are pregnant or breastfeeding or expect to become pregnant during the study period
- Other malignant tumors within 2 years
- Any symptom or illness that may interfere with the evaluation of the how well it works and safety of the investigational drug, or any other condition or condition that is not appropriate for participation in the study
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Duarte, California, United States
- Los Angeles, California, United States
- Miami, Florida, United States
- Augusta, Georgia, United States
- Indianapolis, Indiana, United States
- Lexington, Kentucky, United States
- Hackensack, New Jersey, United States
- New Brunswick, New Jersey, United States
- Stony Brook, New York, United States
- The Bronx, New York, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Morgantown, West Virginia, United States
- St Leonards, New South Wales, Australia
- Adelaide, South Australia, Australia
- Melbourne, Victoria, Australia
- Perth, Washington, Australia
- Bengbu, Anhui, China
- Chongqing, Chongqing Municipality, China
+ 53 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Duarte, California, United States; Los Angeles, California, United States; Miami, Florida, United States; Augusta, Georgia, United States; Indianapolis, Indiana, United States and 67 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.