NCT00207792Unknown3 期
Randomized Trial of Filgrastim Versus Placebo Following Allogeneic Bone Marrow Transplantation
Centre National de Greffe de Moelle Osseuse1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2005年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 160
- 试验地点
- 1
研究概览
简要总结
The effect of haematopoietic growth factors on neutrophil recovery after allogeneic bone marrow transplantation is well recognized. Recent laboratory studies demonstrated that these cytokines may also modify T-cell and dendritic cell function, but whether the effect is strong enough to alter the risk of graft-versus-host disease (GvHD) is unclear.
The aim of this randomised study is to determine the effect of granulocyte colony-stimulating factor [G-CSF] (Neupogen; filgrastim) on the risk of acute GvHD after allogeneic bone marrow transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: > 16 years and < 46 years
- •Geno-identical allogeneic bone marrow transplantation
- •Myeloablative conditioning regimen
- •Haematological malignancies and acquired aplastic anemia
- •Written and informed consent
排除标准
- •ECOG performance score > 2
- •T-cell depletion
- •Serum creatinine level > 133 µmol/L
- •Abnormal liver function
- •Positive HIV test
- •Pregnant women
研究者
研究点 (1)
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