Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With Haploidentical Natural Killer Cells in High-risk Acute Myeloid Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 3
- 主要终点
- 2-year overall survival
研究概览
简要总结
The trial investigates the efficacy of adoptive immunotherapy with haploidentical natural killer cells compared to standard chemotherapy (after first complete remission) in patients with a high-risk acute myeloid leukemia being older than 65 years of age and not eligible for allogeneic transplantation
详细描述
Randomised controlled phase-2 trial to determine the efficacy of adoptive immunotherapy with haploidentical natural killer cells in high-risk acute myeloid leukemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed AML other than acute promyelocytic leukemia (APL) according to WHO criteria
- •In AML defined by cytogenetic aberrations the proportion of blasts may be <20%
- •Age ≥60 years
- •Clinical performance corresponding to ECOG score 0-2
- •High-risk karyotype
- •<5% myeloblasts in bone marrow ≥21 days after beginning of most recent chemotherapy
- •maximal two preceding chemotherapy cycles
- •Potentially available haploidentical family donor (child/ sibling), willing and fit for NK cell donation
排除标准
- •AML with favorable or intermediate risk cytogenetic features
- •Persistent aplasia following preceding chemotherapy
- •Relapsed or refractory AML
- •Known pre-existing autoimmune diseases
- •Any severe concomitant condition which makes it undesirable for the patient to participate in the study
- •Any condition which could jeorpadize compliance of the protocol
- •Participation in another clinical trial during or within 4 weeks before study entry
研究组 & 干预措施
Control Intervention
1 cycle of consolidation chemotherapy with high-dose cytarabine
干预措施: Cytarabine (Drug)
NK cells
Infusion of haploidentical NK cells after immunosuppression with cyclophosphamide and fludarabine, followed by immunostimulatory treatment with interleukin-2
干预措施: NK cells (Biological)
结局指标
主要结局
2-year overall survival
时间窗: 2 years after study inclusion
measure time of survival of each patiente up to 2 years after study inclusion
次要结局
- Time to relapse(2 years after study inclusion)
- Relapse-free survival(2 years after study inclusion)
- Yield and purity of NK cells (CD3-CD56+) after CD3 depletion and CD56 enrichment(timepoint of application of NK cells)
- NK cell analysis(2 years after study inclusion)
- Clinical performance (ECOG score)(2 years after study inclusion)
- Incidence and severity of GVHD(6 months after start of treatment)
- Incidence of (S)AEs(5 weeks after start of treatment)