A Prospective, Multicenter, Randomized Controlled Study on the MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 154
- 试验地点
- 11
- 主要终点
- Complete remission rate
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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;
干预措施: mitoxantrone liposome, Ara-Cytarabine and azacitidine (Drug)
Daunorubicin, Ara-Cytarabine and 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;
干预措施: Daunorubicin,Ara-Cytarabine, azacitidine (Drug)
结局指标
主要结局
Complete remission rate
时间窗: 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.
次要结局
- Incidence of adverse events(Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days))
- Compound CR rate(Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days))
- No remission rate(Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days))
- 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))
- 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))
- Objective remission rate(Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days))
- 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))
- 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)