NCT00569179终止1 期
A PHASE I TRIAL OF ALLOREACTIVE NK CELLS INFUSION FOLLOWING TRANSPLANTATION OF HAPLOTYPE MISMATCHED, KIR MISMATCHED HIGHLY PURIFIED CD34 CELLS IN PATIENTS WITH ADVANCED OR REFRACTORY MYELOID MALIGNANCIES
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Investigate the maximum-tolerated dose (MTD) of highly-purified alloreactive NK cells infused following haplotype-mismatched, KIR ligand-mismatched transplants in patients with refractory hematological malignancies.
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose of alloreactive NK cells that can be transfused following stem cell transplant.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically documented AML, ALL, MDS, CML,
- •Identification of haploidentical donor
- •LVEF > 45% corrected
- •DLCO > 50% predicted
- •Serum Creatinine <= 2 mg/dL
- •Bilirubin < 2 x ULN
- •AST, ALT < 2 x ULN
- •Age ≤ 65 years
- •Performance Status 0-1
排除标准
- •Patients relapsing <6 months after autologous SCT are not eligible.
- •Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection
- •No HIV disease
- •Non-pregnant and non-nursing
研究组 & 干预措施
Alloreactive NK cell infusion
Experimental
Escalating doses of alloreactive NK cells.
干预措施: CliniMACS CD34 Reagent System (Device)
结局指标
主要结局
Investigate the maximum-tolerated dose (MTD) of highly-purified alloreactive NK cells infused following haplotype-mismatched, KIR ligand-mismatched transplants in patients with refractory hematological malignancies.
时间窗: through Day 128
次要结局
- Assess toxicity associated with the infusion of alloreactive NK cells(through Day 128)
- Assess the risk of acute and chronic GvHD following infusion of alloreactive NK cells.(through Day 128)
- Assess the feasibility of multiple harvesting and purifying NK cells to the relatively high-doses.(through Day 128)
- Describe the frequency and type of infections occurring within the first year following transplantation.(through Day 128)
- Describe immune reconstitution following transplantation.(through Day 128)
研究者
研究点 (1)
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