Azacitidine Combined With Venetoclax and ATRA in Newly Diagnosed AML

• Status: Recruiting
• Trial end date: 2025-03-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a single arm study to evaluate the safety and efficiency of azacitidine (AZA) combination with venetoclax and ATRA in Patients With Newly diagnosed acute myeloid leukemia. Azacitidine, venetoclax and ATRA, may stop the growth of cancer cells, either by demethylation, by promoting cells differentiation or by killing the cells.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University
• Treatments: Azacitidine; Venetoclax

Criteria

Inclusion Criteria:

• Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia.

• Age ≥ 18years.

• ECOG score: 0-3.

• White blood cell count ≤ 25*10^9/L

• Total bilirubin ≤ 3X the institutional upper limit of normal if attributable to hepatic infiltration by neoplastic disease

• AST (SGOT) and ALT (SGPT) ≤ 3X the institutional upper limit of normal

• Creatinine clearance ≥30ml/min

Exclusion Criteria:

• Pregnancy or lactation.

• Acute promylocytic leukemia or chronic myeloid leukemia in blast crisis.

• Another malignant disease.

• Uncontrolled active infection.

• Left ventricular ejection fraction < 0.3 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.

• Active hepatitis B or hepatitis C infection.

• HIV infection.

• Other commodities that the investigators considered not suitable for the enrollment.