NCT01827579已完成1 期
Adoptive Immunotherapy With CD25/71 Allodepleted Donor T Cells to Improve Immunity After Unrelated Donor Stem Cell Transplant
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Circulating CD3+ve T cell count at 4 months post-SCT
研究概览
简要总结
The purpose of this study is to evaluate whether the administration of allodepleted donor T cells to patients with haematological malignancies after stem cell transplant can improve the recovery of the patients immune system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥16 years
- •Underlying haematological malignancy
- •Planned allogeneic peripheral blood stem cell transplantation from a 10/10 or 9/10 HLA matched unrelated donor, using an Alemtuzumab-based conditioning protocol
- •Written Informed consent
排除标准
- •Life expectancy < 6 weeks
- •Female patients who are pregnant and lactating
- •Patients who are serologically positive for Hepatitis B, C or HIV pre-SCT
结局指标
主要结局
Circulating CD3+ve T cell count at 4 months post-SCT
时间窗: 4 months post transplant
次要结局
- Transplant related mortality at 1 year post-SCT(1 year post transplant)
- Time to recovery of normal T-cell (>700/uL) and CD4 (>300/uL) counts and normal TCR diversity as assessed by Vb spectratyping(1 year post transplant)
- In vitro anti-viral responses of circulating PBMC(1 year post transplant)
- Incidence of grade II-IV acute and chronic GVHD(1 year post transplant)
- Disease-free survival at 1 year post-SCT(1 year post transplant)
研究者
研究点 (2)
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