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

Recruiting now · Phase 3

Conditions studied: Acute Myeloid Leukaemia

In brief

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).

Key facts

Study ID

NCT06345365

Run by

Zhongnan Hospital

People needed

154

Starts

2024-01-18

Expected to finish

2028-12-31

Last updated by the study team

2024-04-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• Physical condition: ECOG score 0-2;
• Obtained informed consent signed by the patient or family.

You may not qualify if…

• 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;
• Patients with active tuberculosis and HIV-positive patients;
• Other blood system diseases at the same time;
• Pregnant or breastfeeding women;
• Inability to understand or comply with the study protocol;
• Previous intolerance or allergy to similar drugs;
• Concurrent participation in other clinical studies;
• Any other condition that prevents the study from proceeding.

Where it is running

• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (enrolling)
• The Central Hospital of Huanggang — Huanggang, Hubei, China
• The First People's Hospital of Jingzhou — Jingzhou, Hubei, China
• Jingzhou Central Hospital — Jingzhou, Hubei, China
• Shiyan Taihe Hospital — Shiyan, Hubei, China
• Xianning Central Hospital — Xianning, Hubei, China
• The Central Hospital of Xiaogan — Xiaogan, Hubei, China
• Yichang Central Hospital — Yichang, Hubei, China
• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Wuxi, Jiangsu, China
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China
• Shanxi Cancer Hospital — Taiyuan, Shanxi, China

Full record on ClinicalTrials.gov

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