A Global, Multicenter, Randomized, Double-blind, Phase 3 Pivotal Registrational Clinical Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (GLORA-3)
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.
• Adequate kidney function.
• White blood cell ≤ 30×10\^9/L.
• Adequate liver function.
• Men, women with childbearing potential, and their partners voluntarily use contraception that researchers consider effective.
• Be able to understand and voluntarily sign written informed consent.
⁃ Patients must be willing and able to complete study procedures and follow-up examinations.