NCT01795378已完成1 期
HLA-Haploidentical Hematopoietic Cell Transplantation and Subsequent Donor Natural Killer Cell Infusion in Refractory Acute Leukemia - A Phase 1-2a STUDY
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- occurrence and severity of side effects of donor natural killer cell infusion
研究概览
简要总结
The protocol treatment is to evaluate clinical effects of donor-derived natural killer cells that are given after HLA-mismatched hematopoietic cell transplantation.
详细描述
Those patients with acute leukemia, which is not responding to coventional chemotherapy, will be treated. The clinical effects will be evaulated in terms of safety (side effects) and anti-leukemia effect.
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
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute leukemia, which are refractory to standard treatment. Patients should be 17 years of age or older. The performance status of the patients should be 70 or over by Karnofsky scale. Patients should not have excessive hepatic dysfunction (bilirubin less than 3.0 mg/dl, AST less than 5 times the upper normal limit).
- •Patients should not have excessive renal dysfunction (creatinine less than 3.0 mg/dl).
- •Patients should not have clinically-evident cardiac or pulmonary dysfunction. Patients and donors must sign informed consent.
排除标准
- •Patients who are pregnant or lactating are not eligible.
结局指标
主要结局
occurrence and severity of side effects of donor natural killer cell infusion
时间窗: 1 year
次要结局
- anti-leukemia effect of donor natural killer cell infusion(2 years)
研究者
Kyoo-Hyung Lee
Professor
Asan Medical Center
研究点 (2)
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