Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Relapse-free survival (RFS)
研究概览
简要总结
The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells as consolidation therapy for children/young adults with intermediate risk AML.
详细描述
Immunotherapy with NK cells may improve the treatment results in AML. For better efficiency high cell doses or several infusions of NK cells are required. For this purpose, donor NK cells are expanded in the presence of feeder K562-mbIL21-41BBL cell line. The cycle of immunotherapy includes chemotherapy (cyclophosphamide, fludarabine) followed by two doses of NK cells infusion.
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
- 6 Months 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary intermediate risk AML in molecular complete remission;
- •primary high risk AML in molecular complete remission awaiting unrelated HSCT;
- •Karnofsky or Lansky performance scale greater or equal to 70;
- •written informed consent.
- •haploidentical family donor;
- •donor suitable for cell donation and apheresis according to standard criteria;
- •written informed consent.
排除标准
- •uncontrolled infection;
- •severe hepatic dysfunction: SGOT or SCPT >=5x upper limit of normal for age;
- •positive serology for human immunodeficiency virus (HIV).
- •pregnancy;
- •positive serology for HIV, hepatitis B or C.
结局指标
主要结局
Relapse-free survival (RFS)
时间窗: 2 years
Time from achievement of CR to the time of relapse or death from any cause.
Overall survival (OS)
时间窗: 2 years
The proportion of patients with overall survival
次要结局
- Persistence of donor NK cells(21 days after the first infusion)
- Number of T, B, NK, activated T and NK cells after immunotherapy(28 days after the first infusion)