This study focuses on patients with newly diagnosed Acute Myeloid Leukemia, a type of blood cancer that affects the bone marrow and blood cells. The research evaluates a combination treatment using two medications: Lisaftoclax (also known as APG-2575), which is taken as oral tablets, and azacitidine, which is given through injection under the skin or into a vein. The purpose is to determine if this combination treatment works better than using azacitidine with placebo in elderly patients or those who cannot receive standard chemotherapy.

The study uses Lisaftoclax, which belongs to a group of medications that work by blocking a protein called BCL-2 that helps cancer cells survive. Azacitidine is a medication that affects how genes work in cancer cells. Patients will receive either Lisaftoclax or placebo tablets along with azacitidine injections. The treatment continues for several months, with regular check-ups to monitor the patient’s health and how well the treatment is working.

During the study, patients will take the medications according to a specific schedule. Lisaftoclax or matching placebo tablets are taken by mouth, while azacitidine is given as an injection either under the skin or into a vein. The maximum daily dose of Lisaftoclax is 600 milligrams, and azacitidine is given at 75 milligrams per square meter of body surface area.