NCT00153582Unknown2 期
Phase II Study of WT1 126-134 Peptide Vaccination in Combination With Adjuvants GM-CSF and KLH in AML
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Generation of T cell response
研究概览
简要总结
In this trial, HLA-A2+ patients with active AML are vaccinated with a peptide from the leukemia-associated antigen WT1 together with immunological adjuvants keyhole limpet hemocyanin (KLH) as T-helper protein and granulocyte macrophage colony stimulating factor (GM-CSF) 4 times bi-weekly, then monthly.
详细描述
In this phase II trial HLA-A2+ patients with active AML without curative treatment option are vaccinated with WT1 126-134 peptide mixed with adjuvant KLH as T-helper protein and GM-CSF 4 times bi-weekly, then monthly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AML or myelodysplastic syndromes (MDS)
- •Partial response (PR) or complete response (CR) or smoldering course without option for allogeneic stem cell transplantation
- •WT1-expression in bone marrow
排除标准
- 未提供
结局指标
主要结局
Generation of T cell response
次要结局
- Clinical outcome
- Safety
研究者
研究点 (2)
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