Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Children/Young Adults With High-risk, Refractory or Relapsed 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
- Objective Response Rate (ORR) (PR+ MLFS+CRi +CR)
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 for children/young adults with primary high risk or refractory AML and relapsed 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.
For patients with high-risk primary AML a cycle of immunotherapy includes chemotherapy (HD-ARA-C+IDA) followed by three doses of NK cells infusion.
For patients with refractory/relapsed AML a cycle of immunotherapy includes chemotherapy (FLAG - fludarabine, cytarabine, G-CSF) followed by three doses of NK cells infusion.
A 2nd cycle of therapy may be administered if a recipient continues to meet the eligibility criteria.
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 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary high risk AML
- •primary refractory AML
- •relapsed AML
- •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
Objective Response Rate (ORR) (PR+ MLFS+CRi +CR)
时间窗: 30 days after every a course of NK immunotherapy
The proportion of patients with complete remission (CR), CR with incomplete hematologic recovery (CRi), morphologic leukemia-free state (MLFS), and partial remission (PR) as measured by response criteria definitions for acute myeloid leukemia.
Overall survival (OS)
时间窗: 1 year
The proportion of patients with overall survival
Leukemia-free survival (LFS)
时间窗: 1 year
Time from achievement of CR/CRi/MLFS to the time of relapse, death in remission, or last follow-up.
次要结局
- Duration of persistence of infused NK cells(21 days after the first infusion)
- Number of T, B, NK, activated T and NK cells after immunotherapy(30 days after the first infusion)