NCT00428233已完成1 期
Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- To collect up to 20 patient samples per year that could potentially be used to prepare autologous tumor cell vaccines.
研究概览
简要总结
The purpose of this research study is to collect, freeze and store leukemia cells from the blood or bone marrow of patients that have advanced chronic lymphocytic leukemia (CLL) that is not in clinical remission. This study is a companion study to DF/HCC clinical trial 06-196 in which the participants' own CLL cells may form part of a vaccine treatment for their leukemia.
详细描述
- It is important to understand that even if the participant consents to allow us to save their leukemia cells, we cannot guarantee that they will be able to receive a vaccine. First, we may not be able to make enough vaccine from the collected cells. Second, they may not be able to participate in a vaccine study in the future for reasons related to the status of your overall health. Third, an appropriate vaccine trial may not be available in the future.
- In order to make the vaccine, leukemia cells will be collected by one or more of the following methods: drawing blood during one of two visits to the clinic; leukapheresis; bone marrow aspiration; or, surgery to remove a lymph node.
- The physician will discuss with the participant which approach is best in their case to ensure the highest number of tumor cells collected.
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
- •Ability to harvest CLL cells from peripheral blood, lymph nodes or bone marrow, defined as > 30% involvement of bone marrow intratrabecular space, or peripheral blood lymphocytosis > 5000/microliter, or surgically accessible lymph nodes of greater than or equal to 2cm.
- •ECOG performance status 0-2
- •18 years of age or older
排除标准
- •Uncontrolled infection
- •Leukemia with active CNS involvement
结局指标
主要结局
To collect up to 20 patient samples per year that could potentially be used to prepare autologous tumor cell vaccines.
时间窗: 2 years
次要结局
未报告次要终点
研究者
Catherine Wu, MD
Principal Investigator
Dana-Farber Cancer Institute
研究点 (2)
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