NCT01944982终止1 期
Salvage Therapy With Chemotherapy and Natural Killer Cells in Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma.
Hospital Infantil Universitario Niño Jesús, Madrid, Spain2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2013年7月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Safety profile (number of AEs per patient)
研究概览
简要总结
To determine safety profile of immunotherapy with natural killer cells and activated expanded (NKAEs) after salvage chemotherapy in relapsed/refractory paediatric T cell lymphoblastic leukaemia and lymphoma.
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
- •Patients aged between 0 and 21 years with relapsed or refractary acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
- •Lansky Index > 60%.
- •Left ventricular ejection fraction > 39%.
- •Negative HIV serology.
- •Provide informed consent in accordance with current legislation.
排除标准
- •Patients with a history of poor compliance.
- •Patients not valid after psycho-social evaluation
- •Severe (4) functional organ disorders (hepatic, renal, respiratory) according to NCI CTCAE v3 criteria
结局指标
主要结局
Safety profile (number of AEs per patient)
时间窗: Two months
次要结局
- Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections(During 14 months)
- time to hematological recovery (days)(2 months)
- days of hospitalization in each cycle(2 months)
- Objective response rate(2 months)
- days of isolation(2 months)
研究者
Antonio Perez-Martinez
Doctor
Hospital Universitario La Paz
研究点 (2)
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