Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- Overall Survival Rate (OS)
研究概览
简要总结
In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen with intermediate dose of cytarabine. In the control arm, patients receive DA regimen with standard dose of cytarabine.The efficacy of induction therapy containing intermediate dose of cytarabine is evaluated and adverse events associated with treatment are recorded.The primary end point is overall survival.
详细描述
In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen with intermediate dose of cytarabine at at a dose of 100mg/㎡/d on day 1-4 and 1g/㎡/Q12h on day5-7. In the control arm, patients receive DA regimen with standard dose of cytarabine at a dose of 100mg/㎡/d on day 1-7. Patients receive consolidation therapy containing high-dose cytarabine after achieved complete remission. Stem-cell transplantation is permitted for patients with intermediate- or poor-risk disease. The efficacy of induction therapy containing intermediate dose of cytarabine is evaluated and adverse events associated with treatment are recorded.The primary end point is overall survival.
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
- None
入排标准
- 年龄范围
- 14 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 14 to 55 years old;
- •Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL subtypes).
- •ECOG score ≤ 2;
- •Patients with eligible laboratory examination including liver,renal and heart function.
- •Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent.
排除标准
- •Patients who had received induction therapy.
- •Secondary leukemia.
- •Patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor.
- •Patients with other blood diseases(for example, haemophiliacs) are excluded.However, patients with abnormal blood count, but with undiagnosed MDS or MPD patients are included.
- •Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
- •With BCR-ABL fusion gene;
- •Pregnant or lactating women;
- •AML with ineligible renal or liver function;
- •AML with active cardiovascular disease;
- •Severe infection disease including uncured tuberculosis pulmonary aspergillosis;
- •Patients had central nervous system involvement when they were diagnosed as AML.
- •Patients with epilepsy or dementia or other mental disease who couldn't understand or follow the research.
- •Drugs, medical, mental or social situation may distract patients from following the research or being evaluated the results.
- •Patients with other factors which were considered unsuitable to participate in the study by the investigators.
研究组 & 干预措施
DA Regimen
Patients receive standard DA induction regimen including daunomycin and cytarabine.
干预措施: Daunomycin and Cytarabine (DA Regimen) (Drug)
Intermediate Dose of DA Regimen
Patients receive DA induction regimen including daunomycin and intermediate dose of cytarabine.
干预措施: Daunomycin and Cytarabine (Intermediate Dose of DA Regimen) (Drug)
结局指标
主要结局
Overall Survival Rate (OS)
时间窗: Within 5 years after randomization
OS is defined as the time from the date of randomization until the date of death from any cause.
次要结局
- Cumulative incidence of relapse(Within 5 years after randomization)
- Complete Remission Rate(Within 2 months after randomization)
- Event-Free Survival Rate(Within 5 years after randomization)
- Relapse-Free Survival Rate (RFS)(Within 5 years after randomization)
- Early Mortality(within 45 days after randomization)