Rapamycin for Prevention of Chronic Graft-Versus-Host Disease
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Improvement of the Rate of Graft Versus Host Disease (GVHD) From the Accepted Rate of 74%.
研究概览
简要总结
The objective of this study is to evaluate feasibility, toxicity and efficacy of using Rapamycin to prevent chronic graft-versus-host-disease (GVHD) during and after the tacrolimus taper in recipients of allogeneic stem cell transplant.
Our hypothesis is that the T cells that can cause chronic GVHD are suppressed but not eliminated by calcineurin inhibitors. Therefore, when the calcineurin inhibitors are discontinued, the T cells may get activated and result in GVHD. Rapamycin on the other hand will allow anergy formation and thus when discontinued, T cells should not get activated. The schedule is designed to have therapeutic rapamycin levels as the tacrolimus is discontinued. Rapamycin will be continued as a single agent for additional 4 weeks and be tapered off in two weeks.
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
- •Age ≥18 years
- •Received an allogeneic MSD or MUD PBSCT
- •24 weeks post SCT
- •Currently on Tacrolimus for GVHD prophylaxis
- •Deemed eligible for tapering off of Tacrolimus by primary BMT physician
排除标准
- •Relapsed Disease
- •Ongoing GVHD
- •Patients whose immunosuppression is being stopped early to treat or prevent relapse
- •Patients with pure red cell aplasia due to ABO mismatched donor
- •Ongoing thrombotic microangiopathy
- •Allergy to rapamycin
- •Women of childbearing potential must have a negative serum pregnancy test performed prior to the start of treatment
研究组 & 干预措施
1
干预措施: Rapamycin (Drug)
1
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Improvement of the Rate of Graft Versus Host Disease (GVHD) From the Accepted Rate of 74%.
时间窗: up to 8 weeks
Percentage of patients free from graft versus host disease
次要结局
- Disease Free Survival(up to 10 weeks)
- Overall Survival(up to 10 weeks)