Rapamycin for Prevention of Chronic Graft-Versus-Host Disease
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.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
-
-
Connecticut
-
New Haven、Connecticut、美国、06520
- Yale University School Of Medicine
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：1个
|
Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus.
The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily.
The dose will be adjusted to keep trough level at 3-12 ng/dl.
Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped.
Rapamycin will then be tapered off over 2 weeks.
The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.
其他名称：
Tacrolimus target level is 5-10 ng/dl.
Tacrolimus taper will start at 26 weeks post SCT.
Tacrolimus will be tapered off over 4-8 weeks.
The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily.
For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Improvement of the Rate of Graft Versus Host Disease (GVHD) From the Accepted Rate of 74%.
大体时间：up to 8 weeks
|
Percentage of patients free from graft versus host disease
|
up to 8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival
大体时间：up to 10 weeks
|
achieved overall survival in regard to leukemia
|
up to 10 weeks
|
|
Disease Free Survival
大体时间：up to 10 weeks
|
achieved disease free in regard to leukemia
|
up to 10 weeks
|
合作者和调查者
调查人员
- 首席研究员：Stuart Seropian, M.D.、Yale University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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