CD34+Stem Cell Selection for Patients Receiving Partially Matched Family or Matched Unrelated Adult Donor Allogeneic Stem Cell Transplantations for Malignant and Non-Malignant Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The safety CD34+ stem cell selection
研究概览
简要总结
CD34+ stem cell selection in children, adolescents and young adults receiving partially matched family donor or matched unrelated adult donor allogeneic bone marrow or peripheral blood stem cell transplant will be safe and well tolerated and be associated with a low incidence of serious (Grade III/IV) acute and chronic graft versus host disease (GVHD).
详细描述
The selection of CD34+ cells is associated with the simultaneous depletion of T cells that are responsible for severe acute and chronic graft versus host disease (GVHD). Successful engraftment is reported in adult patients with malignant and non-malignant disease who received CD34+ selected stem cells from HLA-matched or mismatched mobilized peripheral blood (PBSC) or bone marrow.
Study Design:
Selected patients defined in the eligibility criteria will enrolled on this study. Patients will receive one of either full intensity or reduced intensity regimen based on the patient's disease status, organ function and performance and determined by the PI and will have peripheral blood undergo CD34 selection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adequate renal function defined as:Serum creatinine <1.5 x normal, or Creatinine clearance or radioisotope GFR >60 ml/min/m2 or an equivalent GFR as determined by the institutional normal range.
- •Adequate liver function defined as:Total bilirubin <1.5 x normal, or SGOT (AST) or SGPT (ALT) <3.0 x normal
- •Adequate cardiac function defined as:Shortening fraction >27% by echocardiogram, or Ejection fraction of >47% by radionucleotide angiogram or echocardiogram.
- •Adequate pulmonary function defined as:Uncorrected DLCO >50% by pulmonary function test. For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% on room air.
- •Eligibility for Reduced Intensity Regimen:
- •Adequate renal function defined as:Serum creatinine 2.0 x normal, or creatinine clearance or radioisotope GFR > 40 ml/min/m2 or an equivalent GFR as determined by the institutional normal range.
- •Adequate liver function defined as:Total bilirubin < 2.5 x normal; or SGOT (AST) or SGPT (ALT) < 5.0 x normal.
- •Adequate cardiac function defined as:Shortening fraction of >25% by echocardiogram, or Ejection fraction of >40% by radionuclide angiogram or echocardiogram.
- •Adequate pulmonary function defined as:DLCO >35% by pulmonary function test. For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% in room air.
排除标准
- •Pregnancy/Breast Feeding: Females who are pregnant or breast-feeding are not eligible.
- •Infection: Patients with documented uncontrolled infection at the time of study entry are not eligible.
研究组 & 干预措施
Thiotepa/Cyclophosphamide/ATG
Full intensity with TBI
干预措施: Full Intensity with TBI (Drug)
Busulfan/Melphalan/ATG
Full intensity without TBI
干预措施: Full Intensity (Drug)
Busulfan/Fludarabine/Alemtuzumab
Reduced Intensity Chemotherapy
干预措施: Reduced Intensity (Drug)
Fludarabine/Cyclophosphamide/ATG
Reduced Intensity Chemotherapy for Fanconi Anemia
干预措施: Reduced Intensity (Fanconi) (Drug)
结局指标
主要结局
The safety CD34+ stem cell selection
时间窗: 100 days
serious adverse events will be monitored post transplant to determine if there is an increase vs. historical data related to the CD34+ selection
次要结局
- Immune reconstitution (T, B, DC) following CD34+ selection(3 years)
研究者
Mitchell Cairo
Principal Investigator
New York Medical College