K562/GM-CSF Vaccination in Patients With Myelodysplastic Syndrome
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Hematologic Response Rate as Assessed by Number of Participants Achieving a Major Hematologic Response
研究概览
简要总结
RATIONALE: Vaccines made from cancer cells may help the body build an effective immune response to kill abnormal cells.
PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients with myelodysplastic syndromes (MDS).
详细描述
OBJECTIVES:
Primary
- Determine the safety of GM-K562 cell vaccine in patients with myelodysplastic syndromes.
- Determine the hematologic and cytogenetic response in patients treated with this vaccine.
Secondary
- Determine if vaccination with GM-K562 cell vaccine can induce an immune response to common myeloid antigens (e.g., Wilms' tumor-1 [WT-1], survivin, or proteinase-3), as defined by a 30% increase from baseline in specific cytotoxic T-cells measured by Elispot assay, in patients with myelodysplastic syndromes.
- Determine if immune response correlates with any clinical responses (e.g., hematologic response, resolution of cytogenetic abnormalities, or decrease in other parameters, such as WT-1 mRNA levels).
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 —（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
Hematologic Response Rate as Assessed by Number of Participants Achieving a Major Hematologic Response
时间窗: Baseline, week 21 post-intervention
A major hematologic response is defined as any of the following: hemoglobin increase \>= 2 g/dL from baseline; platelet increase \>= 30k/mcL from baseline; or neutrophil increase \>= 100% or \>= 500/mcL from baseline.
Cytogenetic Response Rate as Assessed by Number of Participants Achieving a Cytogenetic Response
时间窗: Week 21
Cytogenetic response is defined as normalization of pretreatment cytogenetic abnormalities.
次要结局
- Immune Response Rate as Assessed by Number of Participants Who Exhibit Induced Immune Response to WT-1, Survivin, or Proteinase-3(Baseline, week 21 post-intervention)
- Combined Immune and Clinical Response Rate(Week 21 post-intervention)