Acute Myeloid Leukemia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18–65 years; 2. Diagnosis of acute myeloid leukemia (AML) according to the WHO 2022 criteria, with no prior chemotherapy; 3. ECOG performance status score 0–2; 4. Liver function: total bilirubin =30 mL/min; 6. Expected survival >=3 months; 7.The subject has signed the informed consent form for investigational medicinal product treatment.
Exclusion criteria
Exclusion criteria: 1. Acute promyelocytic leukemia (APL) 2. Complicated with central nervous system leukemia 3. Confirmed diagnosis of myeloid sarcoma 4. Concurrent active infection considered uncontrollable by the investigator 5. Positive HBV-DNA or HCV-RNA 6. HIV infection 7. Heart failure of grade >= 2 8. Pregnant or lactating patients 9. Patients refusing enrollment in this study 10. Other patients deemed ineligible for enrollment by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite Complete Remission Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Remission;MRD-negative rate after 4 cycles of treatment;Event-Free Survival;Overall Survival;Overall Response Rate ;incidence rate of infectionincidence rate of bleeding / bleeding incidence;Volume of blood product transfusion;Incidence of other adverse drug reactions assessed per CTCAE Version 5.0; | — |
Countries
China
Contacts
Henan Cancer Hospital