AML96 - Risk-Adapted and Randomized Postremission-Therapy for Adult Acute Myeloid Leukemia Patients. A Cooperative AML-Study of the German SHG-Study Group.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- - rate of complete remission
研究概览
简要总结
The AML96 study examines the feasibility of a risk-adapted postremission treatment strategy including related and unrelated allogeneic stem cell transplantation for high risk AML patients and related allogeneic and autologous stem cell transplantation for standard risk AML patients in a multi-center setting. Furthermore it randomizes patients between intermediate-dose Cytarabine vs high-dose Cytarabine within the first postremission-course.
详细描述
The AML96 study examines the feasibility of a risk-adapted postremission treatment strategy including related and unrelated allogeneic stem cell transplantation for high risk AML patients and related allogeneic and autologous stem cell transplantation for standard risk AML patients in a multi-center setting. Furthermore it randomizes patients between intermediate-dose Cytarabine vs high-dose Cytarabine within the first postremission-course.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •de novo or secondary acute myeloid leukemia of the FAB subtypes M0-M2 and M4-M7
- •de novo or secondary myelodysplastic syndrome FAB subtypes RAEB and RAEB-T
- •written informed consent
排除标准
- •severe comorbidities
- •severe uncontrolled complications of the leukemia
- •previous therapy of leukemia/MDS
- •HIV-Infection
- •known relevant allergy against study medication
- •pregnancy
- •missing written informed consent
结局指标
主要结局
- rate of complete remission
- overall survival
- relapse-free survival
次要结局
- - frequencies and grade of treatment side effects
- - deaths within induction therapy
- - deaths within postremission therapy
- - feasibility according to dosages and time-intervals