NCT00945126终止2 期
Allogeneic Stem Cell Transplantation With CD3/CD19 Depleted Stem Cells of Related or Unrelated Haploidentical Donors in Pediatric Patients With Malignant and Non-malignant Diseases
Johann Wolfgang Goethe University Hospital2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2006年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- To evaluate engraftment after CD3/CD19 depletion of the graft
研究概览
简要总结
The aim of the study is to investigate the feasibility and toxicity of allogeneic haploidentical or unrelated transplantation with CD3/CD19 depleted stem cells associated with a reduced or a standard conditioning regimen in pediatric patients with malignant and non-malignant high-risk diseases, for whom allogeneic stem cell transplantation represents the only possible therapy option and no human leukocyte antigen (HLA) compatible related donors are available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 0 to 30 years
- •Written informed consent from patient and/or parents or guardian
- •Patients with Karnofsky Index > 60%
- •Malignant disease:
- •acute lymphoblastic leukemia
- •acute myeloid leukemia
- •myelodysplastic syndrome
- •chronic myeloid leukemia according to the standard indications
- •solid tumors (e.g. neuroblastoma recurrence, soft-tissue sarcoma, Ewing's sarcoma, osteosarcoma, hepatoblastoma)
- •. Non malignant disease:
- •acquired anemias (e.g. severe aplastic anemia, particularly severe Evans syndrome)
- •congenital anemias (e.g. thalassemia and sickle cell anemia)
- •Women reliable contraception method when appropriate
排除标准
- •Participation in other clinical trials
- •Patients, parents, or guardians unable to understand the nature, the importance and the implications of the procedure
- •Pregnant or nursing women
- •Patients who underwent a stem cell transplantation in the last 250 days
- •Patients with kidney, heart or liver insufficiency
结局指标
主要结局
To evaluate engraftment after CD3/CD19 depletion of the graft
时间窗: within 1 year
次要结局
- To evaluate immunoreconstitution after transplantation by assessing lymphocyte subsets(within 1 year)
研究者
Peter Bader
Prof. Dr. med. Peter Bader
Johann Wolfgang Goethe University Hospital
研究点 (2)
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