Overview
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).
Description
Comparing efficacy and safety of olverembatinib in combination with chemotherapy (investigational arm) vs. investigator's choice of TKI in combination with chemotherapy (control arm).
Eligibility
Inclusion Criteria:
- Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)
- Expected survival of at least 3 months
- ECOG ≤ 2
- Adequate organ function
Exclusion Criteria:
- 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 subjects 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 efficacy and safety of the investigational drug, or any other condition or condition that is not appropriate for participation in the study
