NCT02074657已完成2 期
"LANK-2": Activated and Expanded NK Cell Immunotherapy Together With Salvage Chemotherapy in Children, Adolescents and Young Adults With Relapsed or Refractary Acute Leukemia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- To assess the safety of activated and expanded NK cell (NKAE) immunotherapy after salvage chemotherapy in patients with relapsed or refractary acute leukemia
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 children, adolescents and young adults with relapsed or refractary acute leukemia
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 23 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 0 and 23 years of age with diagnosis of acute lymphoblastic leukemia, in second relapse situation, posttransplant relapse or refractary, or
- •Patients between 0 and 23 years of age with diagnosis of acute myeloblastic leukemia, relapsed or refractary. (Patient must meet inclusion criteria 1 or 2)
- •Lansky index > 60%
- •Mild (<2) functional organs alteration (hepatic, renal, respiratory) according to National Cancer Institute criteria (NCI CTCAE v4).
- •Left ventricular ejection fraction > 39%
- •To grant informed consent in accordance with the current legal regulations.
- •Presence of a compatible haploidentical donor (father or mother or brother).
排除标准
- •Patients with history of bad therapeutical compliance
- •Patients not valid after psycho-social evaluation
- •Positive HIV serology
结局指标
主要结局
To assess the safety of activated and expanded NK cell (NKAE) immunotherapy after salvage chemotherapy in patients with relapsed or refractary acute leukemia
时间窗: 2 months after infusion
Number of patients with adverse events according to NCI-CTCAE v4.0 CRITERIA as a measure of safety and tolerability
次要结局
- Days of hematological recovery (neutrophils >500/microL, lymphocytes >250/microL and platelets >50.000/microL), days of hospitalization, in each cycle Immune(End of infusion and follow-up (2 months and 1 year))
- Objective response rate according to cytomorphic and by "minimal residual disease" criteria (cytometry and/or real time PCR) at the end of the treatment(End of infusion and follow-up (2 months and 1 year))
- Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections(End of infusion and follow-up (2 months and 1 year))
- Immune reconstitution: Median of T-cell , B, NK, Natural Killer T cell (NKT) and dendritic cells count and subpopulations of T and NK lymphocytes (cel/microL) during posttreatment follow-up period.(End of infusion and follow-up (2 months and 1 year))
研究者
Antonio Pérez Martínez
MD, Servicio de Hemato-Oncología Pediátrica
Hospital Universitario La Paz
研究点 (4)
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