Response to vaccination in lymphoma patients treated with CHOP and rituximab.

Conditions: cancer of the lymph nodes
10047438
10025320
Lymphoma

Registration Number: NL-OMON38294

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 160

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.;Controls:
1. Age, sex and co-morbidity matched controls

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.;Controls:
1. Immunocompromised persons will be excluded (for example immunosuppressive medication).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Immune response to vaccination in patients who were treated with rituximab, in<br /><br>association with the reconstitution of immune function. Parameters are:<br /><br>• Antibody titres the influenza virus vaccine before and after vaccination. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Immunoglobulin levels and subclass.<br /><br>• Lymphocyte subsets (number of B cells and memory-B cells, CD3, CD4, CD8 and<br /><br>NK cells).<br /><br>• Production of IFN-* by CD4+ cells. This will be measured in order to<br /><br>investigate if cellular mediated immune responses are intact after rituximab<br /><br>treatment.<br /><br>• Cytokines and genetic factors (for example BAFF, CXCL13, APRIL) influencing B<br /><br>cell development and survival will be measured in order to determine if there<br /><br>is a correlation between specific cytokines/genetic factors and the observed<br /><br>B-cell depletion/reconstitution.<br /><br>• Serum rituximab levels.<br /><br>• The relationship between time after last dose, number of doses of rituximab<br /><br>and chemotherapy and increase in antibody titres. At what time point after<br /><br>rituximab adequate antibody titres can be generated.</p><br>