Global Phase 3 Study of APG-2575 Lisaftoclax Combined With Azacitidine for Adults with Newly Diagnosed Acute Myeloid Leukemia Not Eligible for Standard Chemotherapy

What this Trial Is About

Researchers are evaluating the combination of APG-2575 Lisaftoclax and azacitidine compared to placebo combined with azacitidine in patients newly diagnosed with acute myeloid leukemia AML who cannot receive standard chemotherapy. This phase III, global, randomized, double-blind, placebo-controlled study aims to determine the effectiveness of this treatment approach in elderly or unfit AML patients. The study is sponsored by Ascentage Pharma Group Inc. and focuses on improving outcomes in this challenging population. Participants will be randomly assigned to receive either the investigational treatment of oral APG-2575 daily plus azacitidine injections or a placebo with azacitidine. Azacitidine is given by subcutaneous or intravenous injection on days 1 to 7 of each 28-day cycle, while APG-2575 or placebo is taken orally every day during each cycle. The treatment continues across multiple cycles with monitoring for up to five years, including evaluation of overall survival and response rates. During the study, participants will undergo regular assessments including safety evaluations, laboratory tests, and follow-up examinations to monitor treatment effects and adverse events. The primary outcome measured is overall survival over up to five years. Secondary outcomes include response rates and safety based on adverse event reports. Participants must be able to take oral medication, consent to the study, and complete all required procedures throughout the study period, which extends until 2029.

A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia