Treatment of AML in Adults 50 to 70 Years, Study of Two Anthracyclines and the Interest of Maintenance Treatment With Interleukin 26- ALFA 9801
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 420
- 试验地点
- 9
- 主要终点
- To compare idarubicin versus daunorubicin: the duration of the event-free survival (EFS) to compare IL2 versus abstention : the relapse rate assessed during the first year following the start of maintenance treatment with interleukin
研究概览
简要总结
Randomized comparison of standard induction treatment with daunorubicin for 3 days and Idarubicin for 3 or 4 days in adult AML patients between 50 and 70 years. Study of maintenance treatment with IL2
详细描述
Patients from 50 to 70 years with de novo AML were randomized to receive ARAC 200 mg / m² / d IV x 7 d with either DNR 80 mg/m²/dx3d (arm 1) or IDA 12 mg / m²/d x 3 d (arm 2) or 4 d (arm 3). The pts received a failing course of remedial Mitoxantrone involving x 2 and j ARAC 1g / m 2 x / d x 4 days The pts in CR then received 2 courses of consolidation with, according to initial randomization either DNR 80 mg / m² IDA 12 mg / sqm x 1 d (1st treatment) or 2 d (2nd treatment) and ARAC 1 gsm 2/jx x 4 days The pts in CR were then randomized persistent IL2 (5 million IU / m² x 5 d / month in SC for 12 months) or no treatment.
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient from 50 to 70 years
- •AML de Novo
- •No prior therapy for AML
- •Absence of severe infection (WHO grade greater than 2), independent of the AML
- •Cardiac function determined by radionucleotide or echography within normal limits.
- •total bilirubin less than or equal 2N and Serum creatinin less than or equal 2N
- •ECOG performance status 0 to 3
- •Signed informed consent.
排除标准
- •history of neoplasia treated by radiotherapy or chemotherapy
- •Myelodysplasia diagnosed more than 6 months before the diagnosis of AML
- •Prior treatment for AML
- •Uncontrolled infection
- •Other active malignancy
- •Patient unable to undergo regular surveillance
研究组 & 干预措施
Arm1 = Aracytine + Daunorubicin
Aracytine : 200 mg/m2 d1-d7 Daunorubicin : 80 mg/m2 d1-d3
干预措施: chemotherapy (Aracytine + Daunorubicin) (Drug)
Arm 3 = Aracytine And Idarubicin
Aracytine : 200 mg/m2 d1-d7 Idarubicin : 12 mg/m2 d1-d4
干预措施: chemotherapy (Aracytine + Daunorubicin) (Drug)
Arm 2 = Aracytine And Idarubicin
Aracytine : 200 mg/m2 d1-d7 Idarubicin :12 mg/m2 d1-d3
干预措施: chemotherapy (Aracytine + Daunorubicin) (Drug)
结局指标
主要结局
To compare idarubicin versus daunorubicin: the duration of the event-free survival (EFS) to compare IL2 versus abstention : the relapse rate assessed during the first year following the start of maintenance treatment with interleukin
次要结局
- Frequency and severity of adverse events