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

Prior treatment

• Use of strong inducers of CYP3A4 within 7 days prior to the first dose of the investigational drug, and/or use of moderate to strong inhibitors of CYP3A4 within 7 days or 3-5 half-lives (whichever is longer) prior to the first dose of the investigational drug.
• Previous treatment for hematologic disorders.

Other illness

• Active infection that is uncontrolled and requires systemic treatment.
• Patients who has a cardiovascular disability status of New York Heart Association Class \> 2.
• Patients have malabsorption syndrome or other conditions that cannot be administered through the gastrointestinal tract or affect drug absorption.
• Patients had a history of other malignancies prior to study initiation.
• Any other circumstances or conditions, at the discretion of the investigator, make the patient unsuitable to participate in the study.

Other

• The patient was diagnosed with acute promyelocytic leukemia or AML BCR-ABL1 positive.
• Active leukemic infiltration of the central nervous system.

• 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.