KGEL Vaccine After Initial Therapy of Hodgkin's Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Safety and Tolerability
研究概览
简要总结
RATIONALE: Vaccines made from a tumor antigen may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and how well vaccine therapy works in treating patients who have received first-line therapy for Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine immunologic responses in patients who have completed first-line therapy for Hodgkin's lymphoma treated with Hodgkin's antigens-GM-CSF-expressing cell vaccine.
- Determine the durability of these immunologic responses in these patients.
- Determine the utility of an Epstein-Barr virus reporter system for monitoring cellular vaccine responses.
- Determine the safety and tolerability of this vaccine in these patients.
OUTLINE: Beginning 4-6 months after last chemotherapy, patients receive Hodgkin's antigens-GM-CSF-expressing cell vaccine on day 1. Treatment repeats every 3 weeks for up to 4 courses.
Immunologic responses are serially monitored along with disease status.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
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 120 Years（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
研究组 & 干预措施
Cell vaccine after initial therapy for Hodgkin lymphoma
Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy.
干预措施: Hodgkin's antigens-GM-CSF-expressing cell vaccine (Biological)
Cell vaccine after initial therapy for Hodgkin lymphoma
Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy.
干预措施: adjuvant therapy (Procedure)
结局指标
主要结局
Safety and Tolerability
时间窗: After administration of last vaccine at 9 weeks
Immunologic Response
时间窗: 9 months
Durability of Immunologic Response
时间窗: 2 years
Utility of Epstein-Barr Virus Reporter System for Monitoring Cellular Vaccine Responses
时间窗: 2 years
次要结局
未报告次要终点