NCT00823524已完成1 期
Donor NK Cell Infusion for Progression/Recurrence of Underlying Malignant Disorders After HLA-haploidentical HCT - a Phase 1-2 Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
RATIONALE: Giving an infusion of natural killer cells from a donor after a donor stem cell transplant may help kill any remaining cancer cells after the transplant.
PURPOSE: This phase I/II trial is studying the side effects and best dose of donor natural killer cells when given after a donor stem cell transplant in treating patients with advanced cancer.
详细描述
OBJECTIVES:
Primary
- To assess the safety of donor natural killer (NK) cell infusion after HLA-mismatched/haploidentical allogeneic hematopoietic stem cell transplantation from a familial donor in patients with advanced malignant disorders.
- To determine the maximum number of donor NK cells that can be safely given to these patients.
Secondary
- To assess the clinical efficacy donor NK cell infusion, in terms of tumor response, response duration, and survival, in patients with progressive or recurrent malignant disorders.
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
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Safety
时间窗: 15 days to 1 year after transplantation
Safety will be evaluation in terms of transplantation outcomes as well as side effects of donor NK cell infusion
次要结局
- Clinical efficacy of donor NK cell infusion, in terms of tumor response, response duration, and survival(15 days to 1 year)
研究者
Kyoo-Hyung Lee
Professor of Internal Medicine
Asan Medical Center
研究点 (2)
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