BridgeMD
A Global Study Testing the New Drug Olverembatinib combined with chemotherapy for Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (POLARIS-1)
EU CTIS ID: 2024-511496-14-00
What this study is testing
Part 1: To assess the efficacy of olverembatinib plus chemotherapy in newly diagnosed Ph+ ALL patients. Part 2: To assess the efficacy of olverembatinib plus chemotherapy versus investigator’s choice of TKI plus chemotherapy in patients with newly diagnosed Ph+ ALL. The primary endpoint is minimal residual disease (MRD)-negative complete response (CR) rate at the end of induction.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥ 18 years old.
- Meet 2016 WHO classification and diagnostic criteria for Philadelphia chromosome- or BCR/ABL1-positive Ph+ ALL. Patients must be newly diagnosed with Ph+ ALL and haven't received systemic anti-leukaemia therapy previously, except for hydroxycarbamide treatment, vincristine treatment no more than once, and steroids therapy for no more than 28 days.
- Life expectancy of ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Adequate organ function as indicated below: • Hepatic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × Upper Limit of Normal (ULN), serum total bilirubin ≤ 1.5 × ULN (and for patients with Gilbert’s syndrome serum total bilirubin ≤ 3.0 x ULN); • Renal function: Serum creatinine ≤ 1.5 × ULN; or 24 h creatinine clearance (CrCL) must be ≥ 50 mL/min (Cockcroft-Gault formula) when serum creatinine is > 1.5 × ULN; • Coagulation: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) all ≤ 1.5 × ULN; • Cardiac function index: Left ventricular ejection fraction (LVEF) > 50%; • Troponin I or T ≤ ULN; • QT interval corrected using the Fridericia's formula (QTcF) on electrocardiogram (ECG): QTcF ≤ 450 ms in males or ≤ 470 ms in females.
- Males and females of childbearing potential (only postmenopausal women who have not menstruated for at least 12 months or are surgically sterilized can be considered infertile) and their partners voluntarily take effective contraceptive measures throughout the treatment and until at least 4 months after the last dose of the study drug. Male patients are not allowed to donate sperm.
You likely can't join if
- Prior history of chronic myelocytic leukemia and diagnosis of chronic myelocytic leukemia in lymphoid blast phase (BP)
- Any disease or medical condition that is unstable or might affect the patient’s safety or study compliance, such as uncontrolled hypertension, uncontrolled diabetes mellitus, active hemorrhage (within 3 months), severe respiratory system disorder (e.g., chronic obstructive pulmonary disease, severe asthma, etc.), significant renal, nervous, endocrine, metabolic, immune, hepatic, digestive diseases, and mental diseases, etc.
- Use of drugs that are known to possibly cause prolonged ECG QT
- Active fungal/bacterial/viral infection that requires systemic treatment, including but not limited to human immunodeficiency virus (HIV), active viral hepatitis B and hepatitis C, known active COVID-19 (those who have received COVID-19 vaccine or other attenuated live vaccine more than 28 days before enrollment are acceptable).
- Diseases seriously affect oral administration and absorption of drugs or those who have active peptic ulcer
- Contraindications to glucocorticoids and unsuitable for participating in the study, at the discretion of the investigator
See the full eligibility criteria
Who can join
- ≥ 18 years old.
- Meet 2016 WHO classification and diagnostic criteria for Philadelphia chromosome- or BCR/ABL1-positive Ph+ ALL. Patients must be newly diagnosed with Ph+ ALL and haven't received systemic anti-leukaemia therapy previously, except for hydroxycarbamide treatment, vincristine treatment no more than once, and steroids therapy for no more than 28 days.
- Life expectancy of ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Adequate organ function as indicated below: • Hepatic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × Upper Limit of Normal (ULN), serum total bilirubin ≤ 1.5 × ULN (and for patients with Gilbert’s syndrome serum total bilirubin ≤ 3.0 x ULN); • Renal function: Serum creatinine ≤ 1.5 × ULN; or 24 h creatinine clearance (CrCL) must be ≥ 50 mL/min (Cockcroft-Gault formula) when serum creatinine is > 1.5 × ULN; • Coagulation: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) all ≤ 1.5 × ULN; • Cardiac function index: Left ventricular ejection fraction (LVEF) > 50%; • Troponin I or T ≤ ULN; • QT interval corrected using the Fridericia's formula (QTcF) on electrocardiogram (ECG): QTcF ≤ 450 ms in males or ≤ 470 ms in females.
- Males and females of childbearing potential (only postmenopausal women who have not menstruated for at least 12 months or are surgically sterilized can be considered infertile) and their partners voluntarily take effective contraceptive measures throughout the treatment and until at least 4 months after the last dose of the study drug. Male patients are not allowed to donate sperm.
- Female patients of childbearing potential have negative serum pregnancy test results within 7 days prior to the first dose
- Patients must be able to understand and voluntarily sign a written informed consent form that has been approved by the Ethics Committee (EC) and voluntarily complete study procedures and follow-up examinations
What rules you out
- Prior history of chronic myelocytic leukemia and diagnosis of chronic myelocytic leukemia in lymphoid blast phase (BP)
- Any disease or medical condition that is unstable or might affect the patient’s safety or study compliance, such as uncontrolled hypertension, uncontrolled diabetes mellitus, active hemorrhage (within 3 months), severe respiratory system disorder (e.g., chronic obstructive pulmonary disease, severe asthma, etc.), significant renal, nervous, endocrine, metabolic, immune, hepatic, digestive diseases, and mental diseases, etc.
- Use of drugs that are known to possibly cause prolonged ECG QT
- Active fungal/bacterial/viral infection that requires systemic treatment, including but not limited to human immunodeficiency virus (HIV), active viral hepatitis B and hepatitis C, known active COVID-19 (those who have received COVID-19 vaccine or other attenuated live vaccine more than 28 days before enrollment are acceptable).
- Diseases seriously affect oral administration and absorption of drugs or those who have active peptic ulcer
- Contraindications to glucocorticoids and unsuitable for participating in the study, at the discretion of the investigator
- Hemorrhagic disorder unrelated to the tumor: such as congenital hemorrhagic disorder (e.g., angiohaemophilia von Willebrand disease), acquired hemorrhagic disorder diagnosed within 1 year (e.g., acquired factor VIII inhibitor), etc.
- A major surgery within 14 days prior to the first dose of the study drug (except for minor surgeries such as bone marrow biopsy and deep vein catheterization) or those who haven’t fully recovered from previous surgeries, at the discretion of the investigator.
- Hypersensitivity to ingredients, excipients or analogues of drugs used in the study
- Females who are pregnant, breastfeeding, or planning to become pregnant during the study or within 4 months of Olverembatinib after the last dose
- Other malignancies within 2 years prior to enrollment, with the exception of: adequately treated cervical carcinoma in situ or breast carcinoma in situ; completely excised skin basal cell carcinoma or localized squamous cell carcinoma of the skin. It is necessary to discuss with the Sponsor for patients with a history of localized malignancy that has been cured by excision (or other methods) which will not affect safety and efficacy evaluation of the study, at the discretion of the investigator.
- Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly
- Any symptom or disease that may compromise patients' safety or interfere with the efficacy and safety assessment of the study drug, or any other situation or condition unsuitable for participating in the study. In special circumstances, a decision will be made after the investigator discusses with the Sponsor
- Previous or current clinical CNS diseases, e.g., epilepsy, epileptic seizure of children or adults, paresis, alogia, apoplexy, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or mental aberration
- Autoimmune disorders that may involve CNS.
- Use of anticoagulants and/or antiplatelet drugs at therapeutic doses, but those using low-dose anticoagulants for keeping the central line patent are acceptable.
- Use of a drug for other concomitant diseases which interacts with the study drug (e.g., strong CYP2C9 inducers or inhibitors and moderate to strong CYP3A4 inducers or inhibitors) within 7 days or 5 half-lives prior to the first dose (whichever is shorter).
- Presence of any of the following heart injuries at screening: a. New York Heart Association (NYHA) Class III to IV; b. Uncontrolled angina, congestive cardiac failure or myocardial infarction within 6 months prior to the first dose; c. Second-degree type II, third-degree atrioventricular (AV) block or PR interval > 250 ms, etc.; d. Various factors that have a potential to increase the risk of prolonged QTcF or arrhythmia, such as cardiac failure, hypopotassaemia, congenital long QT syndrome, and a family history of sudden death of unknown cause before the age of 40 years in a first-degree relative;
- Any venous thromboembolism within 6 months before randomization, including but not limited to deep vein thrombosis (DVT) or lung embolism
- Use of prohibited drugs within 7 days or 5 half-lives prior to the first dose (whichever is shorter);
The study team makes the final eligibility decision.
Where it's taking place
- Russian Federation
- Turkey
- Singapore
- United Kingdom
- Australia
- United States
- China
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Russian Federation; Turkey; Singapore; United Kingdom; Australia; United States and 1 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 EU CTIS; the study team decides eligibility.