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临床试验/NCT01071226
NCT01071226已完成不适用

CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation With The CliniMACS Device for T and B Cell Depletion

Medical College of Wisconsin2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年5月最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
To measure the incidence and quality of engraftment
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

T cell depletion utilizing the CliniMACS device will allow more precise, specific and controlled graft engineering of peripheral blood stem cells from unrelated and partially matched related donors without an increase in relapse or graft rejection and grade III or IV acute graft versus host disease (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
Treatment
盲法
None

入排标准

年龄范围
— 至 22 Years（Child, Adult）
性别
All
接受健康志愿者
否

入选标准

  • •All races are eligible
  • •Malignant diseases: Leukemias and Lymphomas
  • •Non-malignant diseases: Severe Aplastic Anemia, immunodeficiencies

排除标准

  • •Lansky or Karnofsky > 70
  • •Echo > 27% shortening fraction
  • •renal function:serum creatinine < 1.5 x for normal age
  • •no active untreated infection
  • •DLCO > 50% of predicted value
  • •Hepatic: AST and ALT < 3x upper limit of normal; bilirubin < 2.0.

结局指标

主要结局

To measure the incidence and quality of engraftment

时间窗: Weekly for first 100 days, 6 months and 1 year

次要结局

  • Evaluate the incidence of acute Graft versus Health Disease and treatment related mortality.(weekly for the first 100 days and then 6 and 12 months post transplant date)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julie-An M. Talano

Associate Professor of Pediatrics and Director of Clinical Pediatric BMT Research

Medical College of Wisconsin

研究点 (2)

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