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)
Loading locations...
相似试验
已完成
不适用
Does hydroxychloroquine provide effective pain relief for people with hand osteoarthritis?Hand osteoarthritisMusculoskeletal DiseasesOther arthrosisISRCTN91859104niversity of Leeds (UK)248
已完成
2 期
A Randomised Trial Investigating the Additional Benefit of Hydroxychloroquine(HCQ)to Short Course Radiotherapy (SCRT) in Patients Aged 70 Years and Older With High Grade Gliomas (HGG)GlioblastomaNCT01602588University College, London54
已完成
2 期
Hydroxychloroquine in Previously Treated Patients With Metastatic Pancreatic CancerPancreatic CancerNCT01273805Dana-Farber Cancer Institute20
Unknown
1 期
Hydroxychloroquine for Discordant CD4 Responders on Highly Active Antiretroviral Therapy (HAART)HIV InfectionNCT01232660St Stephens Aids Trust12
撤回
3 期
Assessment of the Efficacy and Safety of (HCQ) as a Prophylaxis for COVID19 for Health ProfessionalsCOVID19Sars-CoV2HydroxychloroquineProphylaxisHealthcare WorkerNCT04349228Abderrahmane Mami Hospital