A global, multicenter, randomized, double-blind, placebo-controlled, phase III pivotal registration study, to evaluate the efficacy of APG-2575 (Lisaftoclax) combined with azacitidine (AZA) versus placebo combined with azacitidine in newly diagnosed acute myeloid leukemia who are not eligible for standard induction chemotherapy.
Patients must have newly diagnosed AML that meets the criteria for acute myeloid leukemia (AML) and ineligible for standard chemotherapy.
Life expectancy of ≥3 months.
Be able to accept oral administration.
Patients aged ≥70 years with ECOG score of 0-2, or those aged≥18 years and <70 years with ECOG score of 0-3.
The patient was diagnosed with acute promyelocytic leukemia or AML BCR-ABL1 positive.
Active leukemic infiltration of the central nervous system.
Active infection that is uncontrolled and requires systemic treatment.
Use of strong inducers of CYP3A4 within 7 days prior to the first dose of the investigational drug, and/or use of moderate to strong inhibitors of CYP3A4 within 7 days or 3-5 half-lives (whichever is longer) prior to the first dose of the investigational drug.
Parallel
APG-2575(Lisaftoclax )
DrugQD, oral administration, every 28 days for a dosing cycle.
Placebo
Other interventionQD, oral administration, every 28 days for a dosing cycle.
Azacitidine Injection
DrugQD, subcutaneous or intravenous injection, D1-7 in 28-day cycle.
Overall Survival（OS）
The primary endpoint was overall survival (OS), defined as the time from the date of randomization to the date of death of any cause.
Percentage of Participants with Objective Response Rate (ORR)
ORR is defined as the proportion of patients who have achieved CR, CRi, CRh, MLFS or PR.
Safety evaluation based on the adverse event concurrence
Number of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated.
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