AML
Conditions
Interventions
Experimental Group:Venetoclax, Azacitidine, and Homoharringtonine
Sponsors
the First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
60 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients with newly diagnosed primary acute myeloid leukemia (AML). The diagnostic criteria refer to the 2022 WHO classification. 2.Aged 60-75 years. 3.Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 . 4.Left ventricular ejection fraction (LVEF) >=45% by echocardiography. 5.Creatinine clearance rate >=50 mL/min (calculated by the Cockcroft-Gault formula or measured via 24-hour urine sample). 6.Liver function indicators: aspartate aminotransferase (AST) <= 3×upper limit of normal (ULN); alanine aminotransferase (ALT) <= 3×ULN; total bilirubin <= 1.5×ULN* (*unless deemed caused by leukemia infiltration). 7.Patients or their guardians agree to participate in the clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Acute promyelocytic leukemia (APL). 2.Patients who have received prior anthracycline treatment. 3.AML patients with known central nervous system (CNS) involvement. 4.Subjects with known HIV infection (due to potential drug-drug interactions between antiretroviral drugs and venetoclax). HIV testing will be performed during screening in accordance with local guidelines or institutional standard requirements. 5.Patients with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (referring to those with positive virus test results and abnormal liver function). 6.Subjects who received strong or moderate CYP3A inducers/inhibitors within 7 days before initiating study treatment. 7.Subjects with New York Heart Association (NYHA) Functional Classification > Class 2. Class 2 is defined as patients with heart disease who have no symptoms at rest, but experience fatigue, palpitations, dyspnea, or angina during ordinary physical activity. 8.Subjects with chronic respiratory diseases requiring continuous oxygen therapy. 9.Patients unable to take oral medications or with malabsorption syndrome. 10.Presence of uncontrolled systemic infections (viral, bacterial, or fungal). 11.Previous treatment with venetoclax and/or current participation in any other study involving investigational drugs. 12.Inability to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year EFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| CRc rate;overall survival;MRD;relapse free survival;adverse events; | — |
Countries
China
Contacts
Public ContactJie Jin; Huafeng Wang
the First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed