A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia
Ascentage Pharma Group Inc. · Hematology Hospital of the Chinese Academy of Medical Sciences, Tianjin, Tianjin Municipality
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.
Eligibility: 18 Years to · All · 1. Patients must have newly diagnosed AML that meets the criteria for acute myeloid leukemia (AML) and ineligible for standard chemotherapy. 2. Life expectancy of ≥3 months. 3. Be able to accept oral administration. 4. Patients aged ≥70 years with ECOG score of 0-2, or those aged≥18 years and \<70 years with ECOG score of 0-3. 5. Adequate kidney function. 6. White blood cell ≤ 30×10\^9/L. 7. Adequate liver function. 8. Men, women with childbearing potential, and their partners voluntarily use contraception that researchers consider effective. 9. Be able to understand and voluntarily sign written informed consent. 10. Patients must be willing and able to complete study procedures and follow-up examinations.