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

Inclusion Criteria:

1. Patients must have newly diagnosed AML that meets the criteria for acute myeloidleukemia (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 yearswith 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 usecontraception 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-upexaminations.

Exclusion Criteria:

1. The patient was diagnosed with acute promyelocytic leukemia or AML BCR-ABL1positive.

2. Active leukemic infiltration of the central nervous system.

3. Active infection that is uncontrolled and requires systemic treatment.

4. Use of strong inducers of CYP3A4 within 7 days prior to the first dose of theinvestigational drug, and/or use of moderate to strong inhibitors of CYP3A4 within 7days or 3-5 half-lives (whichever is longer) prior to the first dose of theinvestigational drug.

5. Previous treatment for hematologic disorders.

6. Patients who has a cardiovascular disability status of New York Heart AssociationClass > 2.

7. Patients have malabsorption syndrome or other conditions that cannot be administeredthrough the gastrointestinal tract or affect drug absorption.

8. Patients had a history of other malignancies prior to study initiation.

9. Any other circumstances or conditions, at the discretion of the investigator, makethe patient unsuitable to participate in the study.