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Recruiting
NCT05654194
Azacitidine Combined With Venetoclax and ATRA in Newly Diagnosed AML
Conditions: Acute Myeloid Leukemia
Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 30
Sponsor: The First Affiliated Hospital of Soochow University
Location: China
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.
Eligibility 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/LTotal bilirubin ≤ 3X the institutional upper limit of normal if attributable to hepatic infiltration by neoplastic diseaseAST (SGOT) and ALT (SGPT) ≤ 3X the institutional upper limit of normalCreatinine clearance ≥30ml/minExclusion 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.
Source: ClinicalTrials.gov (NCT05654194). StuddyBuddy aggregates publicly available trial information.