HLA-haploidentical Allogeneic Hematopoietic Cell Transplantation Using CD3 Depletion for Children and Adolescents With Acute Leukemia, Myelodysplastic Syndrome and Solid Tumors After Conditioning of TBI, Fludarabine, Cyclophosphamide and Antithymocyte Globulin
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Transplantation-related mortality and overall survival of TBI, Fludarabine, Cyclophosphamide and anti-thymocyte globulin for engraftment of CD3 depleted haploidentical peripheral blood stem cells.
研究概览
简要总结
RATIONALE: Conditioning with total body irradiation (TBI) and fludarabine, cyclophosphamide and anti-thymocyte globulin may induce the engraftment cross the immunologic barrier in the setting of HLA-haploidentical allogeneic hematopoietic cell transplantation. In addition, T-cell depletion may contribute to prevent developing severe acute graft versus host disease (GVHD) in haploidentical transplantation.
PURPOSE: This phase I/II trial is to evaluate the safety and efficacy of TBI, fludarabine, cyclophosphamide and antithymocyte globulin with T-cell depleted graft from haploidentical donors in treating patients with acute leukemia and myelodysplastic syndrome.
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 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
HAPLO
干预措施: anti-thymocyte globulin (Biological)
HAPLO
干预措施: filgrastim (Biological)
HAPLO
干预措施: Total body irradiation (Radiation)
HAPLO
干预措施: Fludarabine (Drug)
HAPLO
干预措施: cyclophosphamide (Drug)
HAPLO
干预措施: Tacrolimus (Drug)
HAPLO
干预措施: Mycophenolate mofetil (Drug)
HAPLO
干预措施: Rituximab (Drug)
结局指标
主要结局
Transplantation-related mortality and overall survival of TBI, Fludarabine, Cyclophosphamide and anti-thymocyte globulin for engraftment of CD3 depleted haploidentical peripheral blood stem cells.
时间窗: 2 years post-transplant
次要结局
- Engraftment and graft failure rates(28 days engraftment and graft failure)
- Incidence of acute GVHD(100 days post-transplant)
- Treatment related mortality(100 days post-transplant)
- Relapse rate and overall survival(2 year after transplantation)
研究者
Ho Joon Im
Principal investigator
Asan Medical Center