Response to Influenza Vaccination in Lymphoma Patients Treated With CHOP and Rituximab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 7
- 主要终点
- Influenza antibody titre
研究概览
简要总结
The purpose of this study is to compare the number of responders to vaccination with the influenza virus vaccine at different time points after last dose of rituximab in patients with lymphoma. Secondly to study the immune-response to vaccination with influenza virus vaccine, after treatment with rituximab in relation to the reconstitution of immune-function.
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
- Prevention
- 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
- 是
入选标准
- •Patients with non-Hodgkin's lymphoma, treated with rituximab (with a range of 6-12 cycles) and who are in remission.
- •Completion of rituximab therapy in the last twelve months before start of the study.
- •Age ≥ 18 years.
- •Signing of informed consent.
排除标准
- •Completion of rituximab therapy 7-8 months before start of the study.
- •Fever at time of vaccination.
- •Previous/known allergic reaction to any of the components of the vaccines given.
研究组 & 干预措施
Early group after rituximab
Patients who received rituximab last dose 3-6 months before influenza vaccination will be the "early group".
干预措施: influenza vaccination with influenza vaccine (Biological)
Late group after rituximab
Patients who received rituximab last dose 9-12 months before influenza vaccination will be the "late group".
干预措施: influenza vaccination with influenza vaccine (Biological)
Control group
Healthy individuals will be receive vaccination with influenza vaccine and will serve as controls.
干预措施: influenza vaccination with influenza vaccine (Biological)
结局指标
主要结局
Influenza antibody titre
时间窗: 3 weeks after vaccination
次要结局
- immunoglobulin levels(6 months)
- IgG subclasses(6 months)
- production of IFN-γ by CD4+ cells(6 months)
- Cytokines(6 months)
- genetic factors(6 months)
- lymphocyte subsets(6 months)
- number of memory B cells(6 months)