MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
Trial Parameters
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Brief Summary
Investigator proposed to apply the new dosage form of mitoxantrone hydrochloride liposomes to the clinical treatment of AML, while combining with cytarabine and azacitidine to form the MA+AZA treatment regimen(Mitoxantrone liposome +Ara-Cytarabine+Azacitidine), which would provide an optimal induction treatment regimen for patients with primary AML by comparing with the traditional chemotherapy regimen, DA+AZA (Daunorubicin+Ara-Cytarabine+Azacitidine).
Eligibility Criteria
Inclusion Criteria: 1. Patients with primary AML with morphologically and immunologically confirmed diagnosis of bone marrow; 2. Age 18-75 years old; 3. Liver and renal function: serum total bilirubin ≤1.5 × upper limit of normal (ULN), AST/ALT \<2 × ULN, serum creatinine \<1.5 × ULN, 80 ml/min ≤ creatinine clearance ≤120 ml/min; 4. Cardiac function: ejection fraction EF ≥50%, ultrasensitive troponin and natriuretic peptide \<1.5 × ULN; 5. Physical condition: ECOG score 0-2; 6. Obtained informed consent signed by the patient or family. Exclusion Criteria: 1. Allergy or significant contraindication to any of the drugs involved in the protocol; 2. Patients with concomitant myelofibrosis; 3. Severe cardiac disease, including myocardial infarction and cardiac insufficiency; 4. Concomitant malignant tumours of other organs; 5. Patients with active tuberculosis and HIV-positive patients; 6. Other blood system diseases at the same time; 7. Pregnant or breastfeeding women; 8. Inability to unde