Fase I/II, Unicentric, Historical Control Clinical Trial to Evaluate the Effectiveness of Donor IL-15 Stimulated NK Cells Post Transplant Infusion, in Acute Leukemia Patients With Poor Prognosis and Haploidentical Unmanipulated Transplant
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0
研究概览
简要总结
Clinical trial phase I and II, single-center, historical control, to evaluate the effectiveness of donor IL-15 stimulated NK cells post transplant infusion, in acute leukemia patients with poor prognosis and haploidentical unmanipulated transplant
详细描述
This clinical trial wants to study the safety, effectiveness and efficacy of NK cells incubated infusion (CD56 +, CD3) incubated ex vivo with IL-15 infusion in patients with high risk acute myeloid leukemia undergoing allogeneic transplant of an haploidentical donor with post-transplant cyclophosphamide administration.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 18 years old, with acute myeloid leukemia who goes to undergo haploidentical
- •Assessable disease by analytic, molecular or image techniques.
- •Comorbidity Sorror index less than
- •Give informed consent according to the legal requirements.
- •Dispose of a donor without
排除标准
- •Exclusion Criteria:
- •Positive HIV serology.
- •Patients with an active infection or other underlying serious medical statement.
- •Any medical process, analytical abnormality or important psychiatric disorder, according to the investigator's opinion, that prevent the participation of the patient in the study.
- •Participation of any other interventional clincal trial within 30 days of planned enrollment into this study.
- •Women who are pregnant or breastfeeding.
研究组 & 干预措施
NK cells infusion
NK cells incubated infusion (CD56 +, CD3) ex vivo with IL-15 in patients with acute myeloid leukemia undergoing high-risk allogeneic haploidentical Pt-C donor
干预措施: Donor IL-15 stimulated NK cells infusion (Biological)
结局指标
主要结局
Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0
时间窗: Up to 2 years after first infusion
Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0
次要结局
- Reevaluation of the Minimal residual disease (MRD)(Up to 1 year after first infusion)