High-Dose Cyclophosphamide for the Treatment of Severe Autoimmune Enteropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-free Remission at 1 Year After Study Completion
研究概览
简要总结
RATIONALE: Cyclophosphamide may help control the symptoms of autoimmune enteropathy .
PURPOSE: This phase II trial is studying how well cyclophosphamide works in treating young patients with severe autoimmune enteropathy.
详细描述
OBJECTIVES:
Primary
- Determine the rate of treatment-free remission in young patients with severe autoimmune enteropathy treated with high-dose cyclophosphamide.
Secondary
- Determine the toxic effects of this drug in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
研究组 & 干预措施
severe autoimmune enteropathy
Young patients with severe autoimmune enteropathy receive cyclophosphamide IV over 1 hour on days 1-4. Patients then receive filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover
干预措施: filgrastim (Biological)
severe autoimmune enteropathy
Young patients with severe autoimmune enteropathy receive cyclophosphamide IV over 1 hour on days 1-4. Patients then receive filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover
干预措施: cyclophosphamide (Drug)
结局指标
主要结局
Number of Participants With Treatment-free Remission at 1 Year After Study Completion
时间窗: 1 year
Number of participants off therapy 1 year after study completion without relapse.
Number of Participants Experiencing Intervention-related Adverse Events, as Defined by CTCAE at 1 Month
时间窗: 1 month
次要结局
未报告次要终点