NCT00031824已完成3 期
Phase III Trial of Hydroxychloroquine + Standard Therapy for Chronic Graft-Versus-Host Disease
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 203
- 主要终点
- Progression Free Survival
研究概览
简要总结
RATIONALE: Hydroxychloroquine may decrease the immune response and be effective in treating chronic graft-versus-host disease. It is not yet known if standard therapy for graft-versus-host disease is more effective with or without hydroxychloroquine.
PURPOSE: Randomized phase III trial to compare the effectiveness of standard therapy alone with that of standard therapy plus hydroxychloroquine in treating patients who have newly diagnosed chronic graft-versus-host disease.
详细描述
OBJECTIVES:
Primary
- Compare the efficacy of prednisone and cyclosporine with vs without hydroxychloroquine in patients with newly diagnosed extensive chronic graft-versus-host disease (GVHD).
Secondary
- Compare the event-free and overall survival in patients treated with these regimens.
- Compare the health-related quality of life, including longitudinal change in and magnitude of persistent disability, in patients treated with these regimens.
- Correlate cytokine levels and T-helper cell subtypes with chronic GVHD activity and response in patients treated with these regimens.
- Correlate whole blood hydroxychloroquine levels with response and toxicity in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double
入排标准
- 年龄范围
- 1 Year 至 29 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
Progression Free Survival
时间窗: Length of study
次要结局
- Compare the efficacy of a two-drug regimen(Length of study)
- Compare conventional outcomes measures(Length of study)
- To determine if cytokine levels and T helper cell subtypes (Th1 and Th2) correlate with chronic GVHD activity and response(Length of study)
- Determine if whole blood hydroxychloroquine levels correlate with response and toxicity.
研究者
研究点 (203)
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