Procurement of Follicular B Cell Lymphoma Cells From Blood, Tissue or Malignant Effusion for the Purpose of Possible Use in Future Clinical Trials: A Minimal Risk Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Tissue collection for vaccine generation
研究概览
简要总结
In order to learn more about follicular lymphoma and anti-cancer vaccines, we are collecting samples from people with this diagnosis. We then hope to make a vaccine from this tissue to help the immune system destroy cancer cells. We plan on keeping samples in the tissue bank indefinitely.
详细描述
- The following tests and procedures will be performed: Approximately 50cc of peripheral blood will be drawn and stored in the tissue bank; patients who have follicular lymphoma cells circulating in the blood will have about 40cc's of blood drawn and stored for processing; patients undergoing a lymph node biopsy will have samples of the biopsy stored; patients having fluid drained from the abdomen or from around the lung will have some of their fluid saved to cell collection and processing; patients undergoing a bone marrow biopsy will have some of the sample stored for cell collection and processing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed, refractory or de novo histologically confirmed follicular B-cell lymphoma with accessible lymph nodes, tumor mass or malignant effusion or peripheral blood
- •35 years of age or older
排除标准
- •Uncontrolled active infection
- •HIV or viral Hepatitis infection
- •Other current malignancies except any in situ cancer or basal or squamous cell carcinoma of the skin
- •Autoimmune cytopenias
结局指标
主要结局
Tissue collection for vaccine generation
时间窗: 2 years
Collect eligible patient samples that potentially could be used to prepare autologous cell vaccines and possibly prepare autologous tumor cell injection for vaccine induced delayed-type hypersensitiviy evaluation for the companion treatment protocol. There will be no analysis performed on this protocol, the analysis will occur on a companion vaccination protocol. Patients will be consented to this protocol separately.
次要结局
未报告次要终点
研究者
Eric Jacobsen, MD
Principal Investigator
Dana-Farber Cancer Institute