Non-Hodgkin Lymphoma (NHL)
Conditions
Keywords
NHL, influenza vaccination, rituximab
Brief summary
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.
Interventions
BIOLOGICALinfluenza vaccination with influenza vaccine
Sponsors
St. Antonius Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients with non-Hodgkin's lymphoma, treated with rituximab (with a range of 6-12 cycles) and who are in remission. 2. Completion of rituximab therapy in the last twelve months before start of the study. 3. Age ≥ 18 years. 4. Signing of informed consent.
Exclusion criteria
1. Completion of rituximab therapy 7-8 months before start of the study. 2. Fever at time of vaccination. 3. Previous/known allergic reaction to any of the components of the vaccines given.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Influenza antibody titre | 3 weeks after vaccination |
Secondary
| Measure | Time frame |
|---|---|
| lymphocyte subsets | 6 months |
| immunoglobulin levels | 6 months |
| IgG subclasses | 6 months |
| number of memory B cells | 6 months |
| Cytokines | 6 months |
| genetic factors | 6 months |
| production of IFN-γ by CD4+ cells | 6 months |
Countries
Netherlands
Outcome results
None listed