A Randomized Study to Evaluate the Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia in Elderly Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 18
- 主要终点
- Disease free Survival (DFS)
研究概览
简要总结
The present study aims to compare the efficacy of postremission maintenance therapy with 5-Aza versus best supportive care (BSC) in a cohort of AML patients aged >60 years, who have achieved complete remission (CR) following conventional induction ('3+7') and consolidation chemotherapy.
详细描述
The present study aims to compare the efficacy of postremission maintenance therapy with 5-Aza versus best supportive care (BSC) in a cohort of AML patients aged >60 years, who have achieved CR following conventional induction ('3+7') and consolidation chemotherapy to evaluate 2 an 5 year post-remission rates of Overall Survival and disease free survival between two arms
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
- 61 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 61 years or more
- •Newly diagnosed AML with > 30% myeloid marrow blasts, either "de novo" or evolving from a MDS not previously treated with chemotherapeutic agents.
- •Absence of central nervous system involvement
- •No contraindications for intensive chemotherapy, defined as:
- •prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range;
- •a creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related;
- •a Performance Status (PS) score of > 2;
- •uncontrolled severe infection.
- •Informed consent.
排除标准
- •Age ≤ 60 years
- •Newly diagnosed AML with < 30% myeloid marrow blasts
- •Previously treated AML
- •Central nervous system involvement
- •Prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range;
- •A creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related;
- •A PS score of > 2;
- •Uncontrolled severe infection.
研究组 & 干预措施
Azacitidine
Vidaza consists of 50 mg/ m2 s.c or i.v for 7 days (5 + weekend off + 2) every 28 days and increase after 1st cycle, if well tolerated, to 75 mg/m2 s.c or i.v. for 7 days (5 + weekend off + 2) every 28 days for further 5 cycles followed by cycles every 56 days for 4 years and six months
干预措施: Vidaza 100 milligram (mg) injection (Drug)
Best supportive care
No drug administration
干预措施: Best Supportive Care (Other)
结局指标
主要结局
Disease free Survival (DFS)
时间窗: 5 years
Disease-free survival (DFS) at 2 and 5 years. Events for DFS are death and first relapse (either AML or myelodysplastic syndrome (MDS) recurrence) and death; observations are censored at the date of last contact if alive and disease-free. DFS will be calculated from the date of achievement of CR to the date of 1st relapse or death. Patients still alive in 1st CR will be censored at the moment of last visit/contact.
次要结局
- Hospitalizations(5 years)
- Overall Survival (OS)(2 and 5 years)