CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation With The CliniMACS Device for T and B Cell Depletion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To measure the incidence and quality of engraftment
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.
研究组 & 干预措施
Stratum 1
Patients receiving an unrelated donor or partially matched related donor.
干预措施: CliniMACS (CD+3, CD+19 depletion) (Device)
Stratum 1
Patients receiving an unrelated donor or partially matched related donor.
干预措施: HSCT (Other)
Stratum 2
For the patient's whose donors are haploidentical or a 2 antigen mismatched where one of the mismatches includes DRB1
干预措施: CliniMACS (CD 34+ positive selection) (Device)
Stratum 2
For the patient's whose donors are haploidentical or a 2 antigen mismatched where one of the mismatches includes DRB1
干预措施: HSCT (Other)
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
Julie-An M. Talano
Associate Professor of Pediatrics and Director of Clinical Pediatric BMT Research
Medical College of Wisconsin