CTRI/2021/12/038469尚未招募不适用
Open labelled, randomized controlled trial of All allogenic hematopoietic stem cell transplantation (HSCT) with standard graft versus host disease (GVHD) prophylaxis with or without sitagliptin.
Dr Sachin Suresh Jadhav1 个研究点 分布在 1 个国家目标入组 398 人开始时间: 2021年12月13日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 398
- 试验地点
- 1
- 主要终点
- Incidence of acute GVHD as per National Institutes of Health (NIH) consensus criteria
研究概览
简要总结
•Acutegraft-versus-host disease (GVHD) remains a major complication and cause ofdeath after allogeneic hematopoietic stem-cell transplantation (HSCT).With the use of ATG and ptCy the incidence of grade II-IV acute GVHD has been decreased to 20.1% and of chronic GVHD to of moderate/severe chronic GVHD at 1 year to 12.4%, A phase 2 trial, has shown the reduction of grade II-IV acute GVHD to 5% with the addition of sitagliptin in combination with tacrolimus and sirolimus for the prevention of acute GVHD after myeloablative allogeneic peripheral-blood stem-cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •all patients undergoing an allogeneic HSCT in our Department.
排除标准
- 未提供
结局指标
主要结局
Incidence of acute GVHD as per National Institutes of Health (NIH) consensus criteria
时间窗: 5 years
次要结局
- Chronic GVHD at last follow-up(Relapse free survival at last follow-up)
研究者
研究点 (1)
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