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
Ascentage Pharma Group Inc.
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 anticoa…
Interventions
- DrugOlverembatinib
Oral (PO) once every other day (QOD).
- DrugInvestigator's choice of TKI
Oral (PO) once daily (QD).
Locations (90)
- Ascentage Investigative Site #1044Birmingham, Alabama
- Ascentage Investigative Site #1062Duarte, California
- Ascentage Investigative Site #1134Los Angeles, California
- Ascentage Investigative Site #1059Los Angeles, California
- Ascentage Investigative Site #1142Miami, Florida
- Ascentage Investigative Site #1045Augusta, Georgia