Haploidentical Stem Cell Transplantation With CD3/CD19 Depleted Stem Cells in Pediatric Patients With Refractory Hematological and Oncological Diseases
试验速览
- 阶段
- 1 期
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Engraftment rate and transplant related mortality
研究概览
简要总结
Feasibility and toxicity of haploidentical transplantation of CD3/CD19 depleted stem cells in combination with a toxicity reduced conditioning regimen or with standard conditioning regimens according to underlying disease.
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
- 1 Year 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with primary refractory or relapsed disease (including relapse after previous SCT and active disease)
- •AML in complete remission of refractory
- •MDS RAEB-t/secondary AML
- •Non-Hodgkin Lymphoma / Hodgkin Lymphoma
- •non malignant diseases (aplastic anemia, thalassemia, SCID)
- •relapsed Neuroblastoma
- •relapsed soft tissue sarcoma (Rhabdomyosarcoma, Ewing sarcoma, PNET
- •soft tissue sarcoma with primary bone metastases or bone marrow
- •in whom no matched donor was available,
排除标准
- •< 6 months after previous HSCT
- •active cerebral seizure conditions
- •massive progression of leukemias or solid tumours before planned trp.
- •left ventricular ejection fraction <25%
- •creatinine clearance <40ml/min before conditioning
- •respiratory insufficiency with oxygen demand or DLCO <30%
- •Bilirubin >4mg/dl, GOT/GPT >400
- •severe infection (HIV, Aspergillosis)
- •pregnancy
研究组 & 干预措施
Transplantation of CD3/CD19 depleted stem cells
Patients receive a minimum dosage of 10x10E6/kg bodyweight CD3/CD19 depleted CD34+ stem cells. Maximum dosage of residual T cells will be 1x10E5/kg BW
干预措施: Transplantation of CD3/CD19 depleted stem cells (Other)
结局指标
主要结局
Engraftment rate and transplant related mortality
时间窗: 365 days
engraftment rate will be evaluated by leukocyte counts in peripheral blood . Definition of engraftment: \>500 neutrophiles/µl blood. Transplant related mortality will be evaluated at day 100 and day 365 post transplant
次要结局
- Graft versus Host disease and speed of immune reconstitution(365 days)
研究者
Peter Lang
Prof. Dr. med.
University Children's Hospital Tuebingen