MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
- Conditions
- Acute Myeloid Leukaemia
- Interventions
- Registration Number
- NCT06345365
- Lead Sponsor
- Zhongnan Hospital
- 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).
- Detailed Description
In this study, AML patients were randomly divided into MA+AZA treatment group and DA+AZA treatment group by conducting a prospective, multicentre, exploratory, randomised controlled study. By observing the efficacy and safety of the MA+AZA combination regimen in the treatment of primary AML, and comparing the superiority of the traditional regimen, high-quality clinical evidence was obtained, providing practical evidence to support the improvement of the intervention effect and clinical prognosis of primary AML.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 154
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mitoxantrone liposome, Ara-Cytarabine and azacitidine mitoxantrone liposome, Ara-Cytarabine and azacitidine 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 and azacitidine Daunorubicin,Ara-Cytarabine, azacitidine 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;
- Primary Outcome Measures
Name Time Method Complete remission rate Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days) 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.
- Secondary Outcome Measures
Name Time Method Incidence of adverse events Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days) Incidence of adverse events, e.g., GI adverse reactions, cardiotoxicity, etc.
Compound CR rate Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days) CR+ CRi
No remission rate Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days) Patients not meeting criteria for CR, CRi, MLFS or PR
Disease-free survival From date of achieving remission to date of relapse or death from any cause (Assessment of up to 100 months from the date of randomisation to the date of first recorded progress or the date of death from any cause, whichever comes first) For patients achieving CR or CRi only, from the date of achieving remission to the date of relapse or death from any cause
Overall survival Time from the patient's first dose of medication to death from any cause (Assessment of up to 100 months from the date of randomisation to the date of first recorded progress or the date of death from any cause, whichever comes first) The time from the patient's first dose of medication to the time of death from any cause.
Objective remission rate Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days) CR+CRi+MLFS+PR
Event-free survival Assessment of up to 100 months from the date of randomisation to the date of first recorded progress or the date of death from any caus) From the date of the patient's first dose to the date of treatment failure,haematological relapse after CR/CRi or all-cause mortality, whichever occurs first
Mortality rate 30 days, 60 days after starting treatment; Assessment of up to 100 months from the date of randomisation to the date of first recorded progress or the date of death from any cause, whichever comes first Early deaths: all-cause deaths within the timeframe associated with study treatment (e.g., 30 days, 60 days after starting treatment); Cumulative deaths: deaths within the period from the date of achieving remission to the date of no prior relapse for patients achieving CR or CRi only.
Trial Locations
- Locations (11)
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The Central Hospital of Huanggang
🇨🇳Huanggang, Hubei, China
Shiyan Taihe Hospital
🇨🇳Shiyan, Hubei, China
Xianning Central Hospital
🇨🇳Xianning, Hubei, China
The First People's Hospital of Jingzhou
🇨🇳Jingzhou, Hubei, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Jingzhou Central Hospital
🇨🇳Jingzhou, Hubei, China
Yichang Central Hospital
🇨🇳Yichang, Hubei, China
The Central Hospital of Xiaogan
🇨🇳Xiaogan, Hubei, China
Shanxi Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Wuxi, Jiangsu, China