Phase II Study of Valproic Acid With Methylprenisonlone for the Treatment of Grade II-IV Acute GVHD in Patients After Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- complete response
研究概览
简要总结
aGVHD remains as complication in patients after allogeneic stem cell transplantation. Methylprednisolone at 1~2mg/kg is considered as standard first-line treatment. In recent lab study, we demonstrated that valproic acid (VPA) as histone deacetylase inhibitor can inhibit CD4+ Th1 and Th17 cells and control the aGVDH in mice model while preserve the GVL effects. In this study, we tested the hypothesis that adding VPA to standard dose steroid treatment may improve the outcome of aGVHD.
详细描述
To evaluate the complete response rate of VPA+Methylpednisolone in patients with Grade II-IV aGVHD after allogenetic stem cell transplantation.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grade II-IV aGVHD
- •No previous history of allergy to valproic acid
- •No active and severe infection
排除标准
- •Inclusion in other clinical trial
- •GVHD Prophylaxis with valproic acid
- •severe organ dysfunction: heart, lung, liver and kidney
研究组 & 干预措施
VPA+Methyl
VPA added to standard methylpredisonlone treatment for aGVHD
干预措施: VPA (Drug)
结局指标
主要结局
complete response
时间窗: 28 days after the treatment
次要结局
- Overall response (complete + partial response)(28 days after the treatment)
研究者
Jiong HU
Head, Blood and Marrow Transplantation Program
Shanghai Jiao Tong University School of Medicine