NCT00144703已完成2 期
Open Label Phase II Trial of Sirolimus in Combination With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Matched, Related Allogeneic Hematopoietic Stem Cell Transplantation
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- To determine the feasibility of using sirolimus and tacrolimus without methotrexate for GVHD prophylaxis after stem cell transplantation.
研究概览
简要总结
The purpose of this study is to evaluate the ability of sirolimus to prevent graft versus host disease (GVHD) in patients following stem cell transplant from a related donor.
详细描述
- Therapy to prevent GVHD will consist of an infusion of tacrolimus intravenously and sirolimus orally once per day starting 3 days before stem cell infusion. This will take place in the hospital where the patient will remain for the duration of the transplant.
- Sirolimus will continue for 9 weeks at at stable dose, then will be tapered by 1/3 on week 9 and 1/3 on week 17. It will be stopped on week 26 if there is no significant evidence of GVHD. These dose modifications will occur at home and patients will be seen weekly for the first 2 months after discharge.
- If GVHD is present, the tapering schedule wil be slower and based upon the patient's clinical condition.
- Tacrolimus will be given orally once the patient is discharged from the hospital and will be tapered at the same schedule as sirolimus. Blood levels of both tacrolimus and sirolimus will be monitored and the dose adjusted accordingly.
- During the year following stem cell transplant, blood work will be performed to evaluate the immune system and GVHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Patients with hematologic malignancies who will undergo allogeneic HSCT from matched family-members.
- •Age greater than 18
- •ECOG performance status 0-2
- •Total bilirubin < 2.0 mg/dl
- •AST < 90 IU
- •Serum creatinine < 2.0 mg/dl
排除标准
- •Active, uncontrolled infection
- •Ejection fraction < 45% by echocardiogram or MUGA scan
- •Forced vital capacity < 60%
- •Uncontrolled hypertension
- •Second transplantation
- •Evidence of HIV infection
- •Cholesterol > 300 mg/dl
- •Relapsed aggressive Burkitt's or Burkitt's-like lymphoma
结局指标
主要结局
To determine the feasibility of using sirolimus and tacrolimus without methotrexate for GVHD prophylaxis after stem cell transplantation.
次要结局
- To compare the rates of grade II-IV and III-IV acute GVHD with historical controls
- to determine the incidence of 100 day mortality after stem cell transplant using this regimen
- to determine the overall survival at 1 year after transplantation in this patient population.
研究者
Corey S. Cutler, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute
研究点 (2)
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