Acute myeloid leukemia
Conditions
Interventions
AZA maintenance group:AZA (Azacitidine): 50mg/m^2/day, administered subcutaneously (SC), from Day 1 to Day 5.
Reduced dose AZA-VEN maintenance group:AZA (Azacitidine): 50mg/m^2/day, administered subcutaneously (SC), from Day 1 to Day 5
VEN (Venetoclax): 400 mg, orally (PO), once daily from Day 1 to Day 7.
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged > =18 years; 2. Diagnosed with intermediate to adverse AML according to European LeukemiaNet (ELN) 2022 and not eligible for transplantation; 3. Achieved CR after induction therapy and received greater than or equal to 3 courses of medium/high-dose cytarabine (Ara-C) or a regimen based on medium/high-dose Ara-C, or greater than or equal to 6 courses of standard dose chemotherapy consolidation, the patient is in the MRD negative CR1 (CR/CRi) phase; 4. Eastern Cooperative Oncology Group (ECOG) performance status = 60 ml/min, left ventricular ejection fraction (LVEF) >= 50%; 6. Women of childbearing age should have a negative serum or urine pregnancy test within 10-14 days after enrollment; 7. Men of childbearing age should take effective contraceptive measures throughout the entire treatment period and within 30 days after stopping treatment; 8. Patient agrees to be enrolled and signs informed consent.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with acute promyelocytic leukemia; 2. Active central nervous system leukemia; 3. Leukemia with extramedullary invasion; 4. AML secondary to myelodysplastic syndrome or myeloproliferative disorders; 5. Patients with other active malignant tumors; 6. Uncontrolled complications, not limited to active infections, etc; 7. Patients who have participated in other clinical trials within 30 days prior to signing the informed consent form; 8. Women who are pregnant, breastfeeding, or preparing to become pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of MRD-negative remission;Overall survival;Event free survival;The incidence rate of adverse event; | — |
Countries
China
Contacts
Public ContactJia Chen
The First Affiliated Hospital of Soochow University
Outcome results
None listed