Recombinant Human Growth Hormone(RH-GH) For Accelerating Immune Reconstitution In Pediatric and Adult Patients Undergoing Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- To define the safety of recombinant human growth hormone (rh-GH, Genotropin) in a population of patients undergoing allogeneic transplantation
研究概览
简要总结
The primary objective of this study is to define the safety and efficacy of recombinant human growth hormone (rh-GH, Genotropin) in a patients undergoing allogeneic transplantation.
详细描述
The primary objective of this study is to define the safety and efficacy of recombinant human growth hormone (rh-GH, Genotropin) in a population of patients undergoing allogeneic stem cell transplant. The secondary objectives of this study are: to evaluate the incidence of mortality due to opportunistic infections in the first 6 months, to evaluate the incidence and severity of infectious complications, to assess laboratory parameters of post-transplant immune recovery in patients on GH therapy and to determine the probability and time of neutrophil and platelet recovery on GH therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<90 days following Allogeneic Transplantation.
- •ANC>500/ul for 3 consecutive days.
- •≥50% donor cells in all cellular fractions tested.
- •No active grade II or higher acute graft versus host disease
- •Receiving ≤ 1 mg/kg/day Methylprednisolone or equivalent
- •Documentation of morphologic or radiographic remission within 45 days of protocol enrollment
排除标准
- •Patients with acute organ dysfunction requiring monitoring in the Intensive Care unit or receiving invasive interventions that may include, Hemodialysis ,CVVHD, or any form of mechanical ventilation including CPAP/BiPap at the time of starting therapy.
- •Pregnant or lactating patients and those without a negative pregnancy test.
- •Patients must have a life expectancy of at least 3 months.
- •Patients must be HIV negative.
- •Patients must not be receiving investigational agents for treatment of GVHD.
- •Patients with severe veno-occlusive disease as determined by standard criteria.
- •Patients with Type 1 Diabetes at the time of initiation of stem cell transplantation.
结局指标
主要结局
To define the safety of recombinant human growth hormone (rh-GH, Genotropin) in a population of patients undergoing allogeneic transplantation
时间窗: After 6, 12, 18 patients have enrolled
次要结局
- To evaluate the incidence of mortality due to opportunistic infections in the first 6 months.(After 6, 12, and 18 patients have enrolled)
- To evaluate the incidence and severity of infectious complications.(After 6, 12, and 18 patients have enrolled)
- To assess laboratory parameters of post-transplant immune recovery in patients on GH therapy.(After 6, 12, and 18 patients enroll.)
- To determine the probability and time of neutrophil and platelet recovery on GH therapy.(After 6, 12, and 18 patients enroll)
研究者
Mitchell Horwitz, MD
Assoc Professor of Medicine
Duke University