MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)

ConditionAcute Myeloid Leukaemia

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorZhongnan Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patients with primary AML with morphologically and immunologically confirmed diagnosis of bone marrow;

Age 18-75 years old;

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;

Cardiac function: ejection fraction EF ≥50%, ultrasensitive troponin and natriuretic peptide <1.5 × ULN;

Disqualifiers

Allergy or significant contraindication to any of the drugs involved in the protocol;

Patients with concomitant myelofibrosis;

Severe cardiac disease, including myocardial infarction and cardiac insufficiency;

Concomitant malignant tumours of other organs;

Trial design

Design model

Parallel

Treatments tested in this trial

mitoxantrone liposome, Ara-Cytarabine and azacitidine
Drug
Mitoxantrone hydrochloride liposome 24 mg/m2, IV every 4 weeks, day 1; Ara-Cytarabine 100 mg/m2, IV every 12 h, days 1-7; Azacitidine 100 mg, subcutaneous, once daily, days 1 to 7
Daunorubicin,Ara-Cytarabine, azacitidine
Drug
Daunorubicin 60 mg/m2, intravenously, once daily, days 1 to 3; Ara-Cytarabine 100 mg/m2, IV drip, every 12h, days 1 to 7; Azacitidine 100 mg, subcutaneous, once daily, days 1 to 7;

Treatment groups

154 Participants

are divided into 2 treatment groups

Group A: mitoxantrone liposome, Ara-Cytarabine and azacitidineExperimental treatment 1 intervention

Group B: Daunorubicin, Ara-Cytarabine and azacitidineActive comparator 1 intervention

Trial outcomes

Primary outcomes

Complete remission rate

Bone marrow primitive cells \<5%, no primitive cells with Auer vesicles, no primitive cells in the peripheral blood, no extramedullary leukaemia, neutrophil count ≥1.0×109/L, platelet count ≥100×109/L.

Time frame