Response to Influenza Vaccination in Lymphoma Patients Treated With Rituximab

Study Overview
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Brief Summary
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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.

Official Title
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Response to Influenza Vaccination in Lymphoma Patients Treated With CHOP and Rituximab

Conditions
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Non-Hodgkin Lymphoma (NHL)

Intervention / Treatment
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* Biological: influenza vaccination with influenza vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early group after rituximab<br>Patients who received rituximab last dose 3-6 months before influenza vaccination will be the early group. | Biological: influenza vaccination with influenza vaccine<br> <br> * Other names: Vaxigrip;|
| Active Comparator: Late group after rituximab<br>Patients who received rituximab last dose 9-12 months before influenza vaccination will be the late group. | Biological: influenza vaccination with influenza vaccine<br> <br> * Other names: Vaxigrip;|
| Active Comparator: Control group<br>Healthy individuals will be receive vaccination with influenza vaccine and will serve as controls. | Biological: influenza vaccination with influenza vaccine<br> <br> * Other names: Vaxigrip;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza antibody titre |  | 3 weeks after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of memory B cells |  | 6 months | 
| lymphocyte subsets |  | 6 months | 
| immunoglobulin levels |  | 6 months | 
| IgG subclasses |  | 6 months | 
| production of IFN-γ by CD4+ cells |  | 6 months | 
| Cytokines |  | 6 months | 
| genetic factors |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NHL, influenza vaccination, rituximab