Maraviroc as Graft Versus Host Disease Prophylaxis in Pediatric and Adult Stem Cell Transplant Recipients
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Area Under The Concentration-Time Curve (AUC) of Maraviroc
研究概览
简要总结
The purpose is to determine if the addition of Maraviroc to a standard transplant regimen will reduce the incidence of graft versus host disease in children and young adults after a stem cell transplant.
详细描述
In the first stage, drug levels will be obtained to establish appropriate dosing. In the second stage of the study the investigators will study the effects of using Maraviroc in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 5 years and </= 40 years
- •All diagnoses
- •Peripheral blood stem cells, marrow or cord blood
- •All conditioning regimens
- •Patient must be planned to receive a calcineurin inhibitor (cyclosporine or tacrolimus) together with steroid, methotrexate or mycophenolate mofetil as GVHD prophylaxis.
排除标准
- •Documented anaphylaxis to Maraviroc
- •Ex vivo T-cell (type of white blood cell) depleted grafts
- •Abnormal Alanine Aminotransferase (ALT) (>/=10X ULN) on day -
- •(Assessed at study enrollment and confirmed again prior to the first dose of maraviroc.)
研究组 & 干预措施
Maraviroc
Maraviroc administration will start on day -3 and will end on day +30 after stell cell transplant, making the total number of days of drug administration 34 days. Maraviroc will be administered twice daily orally or via enteral tube. Dosing of Maraviroc will be based on body surface area (starting with 100mg twice a day for BSA of 0.2 and up to 300mg twice a day for BSA greater than 1.73).
干预措施: Maraviroc (Drug)
结局指标
主要结局
Area Under The Concentration-Time Curve (AUC) of Maraviroc
时间窗: Day 10
pK target \>100ng/ml at day 10 at the following time points : before the dose and 1, 2, 4, 6, 8, and 12 hours after maraviroc administration
Incidence of Visceral GVHD
时间窗: day+100
determine the number of patients who develop visceral GVHD by day+100
Feasibility of Maraviroc
时间窗: Up to day +100
The ability to administer twice daily oral maraviroc in children and adults undergoing stem cell transplant in addition to routine standard graft versus host disease prophylaxis.
GVHD Incidence
时间窗: By day +100
Incidence of GVHD by day+100
次要结局
- Overall Survival(By day +100)
- Graft Failure(By day +100)
- Primary Disease Relapse(By day +100)
- Toxicities(Up to day +100)
- Infectious Complications(Up to day +100)
- Time to Neutrophil(Up to day +100)
- Time to Platelet Engraftment(days)