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Efficienty of vaccination in patients with cancer who are treated with chemotherapy.


- candidate number10554
- NTR NumberNTR3155
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-nov-2011
- Secondary IDsNL37320.100.11 CCMO
- Public TitleEfficienty of vaccination in patients with cancer who are treated with chemotherapy.
- Scientific TitleResponse to influenza vaccination in lymphoma patients treated with CHOP and rituximab.
- ACRONYMRITUXIVAC
- hypothesisPatients with lymphoma who are treated with rituximab have an increased risk of developing infections. However because of the disease, and because rituximab also diminishes healthy B cells, the humoral response to vaccination may be impaired.
- Healt Condition(s) or Problem(s) studiedNon Hodkin's lymfoma (NHL), Vaccination, Rituximab , Influenza, Humoral immune response
- Inclusion criteria1. 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 control who has an indication for influenza vaccination.
- Exclusion criteria1. 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).
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-sep-2012
- planned closingdate1-mei-2013
- Target number of participants160
- InterventionsInfluenza vaccination.
- Primary outcomePercentage responders.
- Secondary outcomeImmunesystem components (amount of memory Bcells, lymphocyte sbsets etc).
- Timepoints2-6 months after rituximab treatment or 9-12 months after rituximab treatment.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES M. Rab
- CONTACT for SCIENTIFIC QUERIES M. Rab
- Sponsor/Initiator Sint Antonius Ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryRituximab is a chimeric anti-CD20 monoclonal antibody used in combination with chemotherapy for the treatment of non-Hodgkin’s lymphoma (NHL). Following infusion with rituximab, B-cell depletion in the peripheral blood occurs within days. Levels of normal peripheral B-cells remain low for 2-6 months. Because of the immunosuppressive (chemo) therapy, patients might be prone to develop infections with the influenza virus. Vaccination against this virus is, therefore, indicated for these immunocompromised patients. However little is known about the effect of rituximab with chemotherapy in patients with non-Hodgkin lymphoma on the response to vaccination.
Objectives of this study are to investigate what the ideal moment to vaccinate would be, early (after 3-6 months) or late (after 9-12 months) after cessation of rituximab. Secondly to study the immune-response to vaccination with influenza virus vaccine, after treatment with rituximab in relation to the reconstitution of immune-function (in terms of number of B-cells, lymphocyte subsets, immunoglobulin levels and IgG subclasses, CD4+ IFN-alfa production, BAFF, CXCl13 and IL-10).
- Main changes (audit trail)
- RECORD18-nov-2011 - 28-nov-2011


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