Acute Myeloid Leukemia
Conditions
Interventions
Experimental:Alternate consolidation therapy with venetoclax + azacitidine and medium-dose cytarabine for 3 cycles. 1 cycle includes: the first consolidation course (azacitidine 75mg/m2/d, d1~7
venetoclax 400mg/d, d1-d28), the second consolidation course (cytarabine 0.5~1g/m2 q12h*3d)
Active Comparator:6 courses of consolidation therapy with venetoclax + azacitidine ( (azacitidine 75mg/m2/d, d1~7
venetoclax 400mg/d, d1-d28))
Sponsors
Suzhou Hongci Hematology Hospital
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meet the AML diagnostic criteria of WHO-2016 (excluding APL); 2. Age 60-80 years old; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3; 4. AML with low-risk or intermediate-risk cytogenetics; 5. Treatment-naive elderly AML patients; 6. Have the ability to understand and be willing to participate in this research and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. AML transformed from chronic myeloid leukemia; 2. Acute promyelocytic leukemia (M3); 3. Associated with a second malignant tumor; 4. Combined with a serious uncontrolled infection; 5. Cardiac insufficiency: ejection fraction (EF) = 2.0 mg/dl, AST >= 3 times the upper limit of normal, serum creatinine clearance (Ccr) < 50 ml/min; 7. Arterial oxygen saturation (SpO2) <92%; 8. Human immunodeficiency virus (HIV) positive; 9. Active hepatitis B or C infection; 10. Other conditions that the researcher deems unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival;Leukemia-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment related mortality rate;Cumulative incidence of relapse; | — |
Countries
China
Contacts
Public ContactXiao Ma, Weiyang Li
Suzhou Hongci Hematology Hospital
Outcome results
None listed