NCT00574470已完成4 期
Anti Cytokine Combination Therapy With Daclizumab and Infliximab for Treatment of Steroid Refractory Acute GVHD
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Complete or partial response of GVHD to treatment according to standard staging/grading scale
研究概览
简要总结
The purpose of this study is to see whether serious graft versus host disease which is not well controlled with steroid treatment can be controlled with therapy with both daclizumab and infliximab. We hypothesize that a combination of daclizumab and infliximab will more effectively treat graft versus host disease than therapy with a single drug. The study also looks at whether chronic graft versus host disease develops, and survival at 6 and 9 months post-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of steroid refractory aGVHD defined as no response to methylprednisolone at 2 mg/kg for 1 week or disease progression after 72 hours of methylprednisolone at this dose. Potential subject will have had no decrease in any GVHD organ staging as follows:
- •Skin rash, if present, does not decrease by one stage. This is based on the percent of the body involved with rash, plus presence of bullae and desquamation.
- •Gut GVHD, if present, does not decrease by one stage. This is based on volume of diarrhea, pain, and ileus.
- •Upper gastrointestinal GVHD, if present, does not resolve.
- •Liver GVHD, if present, does not decrease by one stage. This is based on total bilirubin level.
- •Prior allogeneic hematopoietic stem cell transplantation using bone marrow, peripheral blood or umbilical cord cells. Recipients of standard as well as nonmyeloablative transplants are eligible.
- •No previous immune suppressive therapy given for treatment of acute GVHD except for corticosteroids.
- •Absolute neutrophil count greater than 0.5x106/L.
- •Estimated creatinine clearance greater than 30 mL/minute.
- •Written informed consent
排除标准
- •Patient receiving either infliximab or daclizumab within seven days of study.
- •Patient with uncontrolled infections will be excluded.
- •Patients receiving other investigational agents for GVHD prophylaxis or treatment.
- •Patients with congestive heart failure.
- •Patients with history of intolerance/ hypersensitivity to daclizumab or infliximab.
- •Age less than 18 years.
- •Patients who are pregnant or at risk of pregnancy and unwilling to use acceptable birth control methods.
- •Patients with an allergy to murine products.
研究组 & 干预措施
1
Experimental
Treatment with daclizumab/infliximab
干预措施: daclizumab, infliximab (Drug)
结局指标
主要结局
Complete or partial response of GVHD to treatment according to standard staging/grading scale
时间窗: 28 days
次要结局
- incidence of chronic GVHD and overall survival(9 months)
研究者
Magalhaes-Silverman, Margarida
Clinical Professor
University of Iowa
研究点 (1)
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