A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia
Trial Parameters
Brief Summary
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 Criteria
Inclusion Criteria: 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. Exclusion Criteria: 1. The patient was diagnosed with acute promyelocytic leukemia or AML BCR-ABL1 positive. 2. Active leukemic infiltration of the central nervous system. 3. Active infection that is uncontrolled and requires systemic treatment. 4. Use of strong i