Multicenter Protocol in Treating Patients With Childhood Acute Myeloid Leukemia. Randomized Study of Maintenance Treatment With Interleukin-2
试验速览
- 阶段
- 3 期
- 入组人数
- 580
- 试验地点
- 1
- 主要终点
- Interest of interleukin-2 in complete remission after induction and consolidation chemotherapy concerning the event free survival (event = relapse of toxic death)
研究概览
简要总结
The purpose of this study is to evaluate the interest of maintenance treatment with interleukin-2 by randomizing the patients being not allogeneic transplanted in complete remission after induction and consolidation chemotherapy concerning the event free survival.
详细描述
We designed an open randomized study to evaluate the interest of maintenance treatment with interleukin-2 by randomizing the patients being not allogeneic transplanted in complete remission after induction and consolidation chemotherapy concerning the event free survival. A total of 580 patients will be accrued over 7 years. Treatment consists in subcutaneous application of interleukin-2 in treating patients with complete remission by a monthly regimen of 5 days during 1 year after having received a chemotherapy consisting of 1 induction and 3 consolidation treatments.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 0 to 18 years
- •Prior untreated acute myeloid leukemia (AML) of following cytological types : FAB M0, M1, M2, M4, M4 eosinophil, M5, M6, M7, without FAB classification or showing myelodysplasia (blasts > 20 %)
- •Isolated myeloid sarcoma
- •Achieved complete remission
- •No HLA identical family donor, except for the patients with t(8;21)
- •No contraindication for the use of interleukin-2
排除标准
- •Trisomy 21
- •Promyelocytic leukemia (M3) or M3 variations
- •Secondary AML
研究组 & 干预措施
1
Patients treated by Proleukin
干预措施: proleukin (Drug)
结局指标
主要结局
Interest of interleukin-2 in complete remission after induction and consolidation chemotherapy concerning the event free survival (event = relapse of toxic death)
时间窗: 1 year
次要结局
- Examine the prognostic biological factors(1 year)
- Analyze the whole toxicity of the regimen(1 year)