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

Ki vehet részt

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

Ki nem vehet részt

• Previous or current clinical CNS diseases
• 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
• 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
• Plan to undergo major surgery
• 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
• A history of chronic myeloid leukemia (CML)
• Autoimmune diseases that may involve the CNS
• Uncontrolled heart diseases
• Disease or medical condition that is unstable or may affect its safety or compliance with the study
• Active infections requiring systemic treatment
• Disease that severely affects the oral administration and absorption of drugs, or an active gastrointestinal ulcer
• Bleeding disorders unrelated to ALL
• Allergy to drug ingredients, excipients, or their analogues in the study
• Other malignant tumors within 2 years
• Use of medications known to cause prolonged QT interval
• Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly
• Use of therapeutic doses of anticoagulants and/or antiplatelet agents; low doses of anticoagulants or antiplatelet agents are allowed
• Contraindications to the use of glucocorticoids
• Female subjects who are pregnant or breastfeeding or expect to become pregnant during the study period