Acute myeloid leukemia
Conditions
Interventions
VA consolidation group: VEN (Venetoclax): 400 mg, orally (PO), once daily from Day 1 to Day 28.
Note: The dose of Venetoclax must be adjusted per prescribing guidelines based on the concomitant u
AraC based consolidation group:AraC 1-2g/m2, every 12 hours, intravenous drip, day 1 to day 3, may be combined with anthracyclines/anthraquinones, proceed to allo-HSCT after 2 cycles of consolidation
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with AML by bone marrow morphology, flow cytometry, and molecular genetics, according to the WHO 2022 classification. 2. Age >= 18 years. 3. Classified as high-risk according to the European Leukemia Net (ELN) risk stratification criteria, including subtypes such as AML with myelodysplasia-related changes (AML-MRC) and therapy-related AML (t-AML). 4. Achievement of Complete Remission (CR) or Complete Remission with Incomplete Hematologic Recovery (CRi) after = 50 mL/min (calculated by the Cockcroft-Gault formula).Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 50% as measured by echocardiography (ECHO). Life expectancy > 8 weeks. 8. Voluntary provision of written informed consent, with the ability to understand and comply with the study requirements
Exclusion criteria
Exclusion criteria: 1. Presence of clinically active cardiovascular disease, such as uncontrolled ventricular arrhythmia, uncontrolled hypertension, congestive heart failure, heart disease classified as Class 3 or 4 according to the New York Heart Association (NYHA) Functional Classification, or a history of myocardial infarction within 3 months prior to screening. 2. Active central nervous system leukemia or extramedullary leukemic infiltration. 3. Other severe medical conditions that may limit the patient's participation in this trial (e.g., severe infection, renal failure). 4. Known infection with Human Immunodeficiency Virus (HIV) or severe viral hepatitis not controlled by medication. 5. Pregnant or lactating women. 6. Inability to comprehend, adhere to the study protocol, or provide written informed consent. 7. Any other condition deemed by the investigator as inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year leukemia free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| MRD-negative rate at allo-HSCT;overall survival;relapse rate;non-relapse rate; | — |
Countries
China
Contacts
Public ContactJia Chen
The First Affiliated Hospital of Soochow University
Outcome results
None listed