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
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
Treatments tested in this trial
- mitoxantrone liposome, Ara-Cytarabine and azacitidine
- Daunorubicin,Ara-Cytarabine, azacitidine
Treatment groups
154 Participants
are divided into 2 treatment groupsSponsors and collaborators
Zhongnan Hospital
Lead sponsor
Ruijin Hospital
Collaborator
Shanxi Province Cancer Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Jingzhou Central Hospital
Collaborator
Yichang Central People's Hospital
Collaborator
Taihe Hospital
Collaborator
Central Hospital of Xiaogan
Collaborator
Xianning Central Hospital
Collaborator
The First People's Hospital of Jingzhou
Collaborator
Source ClinicalTrials.gov