NCT00098683已完成2 期
A Phase II Study Of Amifostine In Children With Myelodysplastic Syndrome
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 169
- 主要终点
- Hematological effects (complete and partial response)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as amifostine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well amifostine works in treating young patients with newly diagnosed de novo myelodysplastic syndromes.
详细描述
OBJECTIVES:
Primary
- Determine the hematologic effects of amifostine, in terms of, complete and partial response, in pediatric patients with newly diagnosed de novo myelodysplastic syndromes (MDS).
- Determine the safety and efficacy of this drug in these patients.
Secondary
- Determine the efficacy of this drug in preventing conversion of MDS to acute myeloid leukemia (AML) in terms of the proportion of patients who remain free of AML at the completion of study treatment.
- Determine the duration of progression-free remission from MDS conversion to AML in patients treated with this drug.
- Determine the effect of karyotypic abnormalities on survival and the duration from diagnosis of MDS until conversion to AML in patients treated with this drug.
- Determine the effect of bone marrow blast count on survival and the duration from diagnosis of MDS until conversion to AML in patients treated with this drug.
- Determine the effect of the number of cytopenias on survival in patients treated with this drug.
- Correlate the duration of time from diagnosis of MDS until conversion to AML with survival in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Hematological effects (complete and partial response)
Safety and efficacy
次要结局
- Effect of the number of cytopenias on survival
- Effect of karyotypic abnormalities on survival
- Efficacy
- Duration of progression-free remission
- Correlation of the duration of time from diagnosis of myelodysplastic syndromes until conversion to acute myeloid leukemia
研究者
研究点 (169)
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