|- candidate number||10554|
|- NTR Number||NTR3155|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-nov-2011|
|- Secondary IDs||NL37320.100.11 CCMO|
|- Public Title||Efficienty of vaccination in patients with cancer who are treated with chemotherapy.|
|- Scientific Title||Response to influenza vaccination in lymphoma patients treated with CHOP and rituximab.|
|- hypothesis||Patients 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) studied||Non Hodkin's lymfoma (NHL), Vaccination, Rituximab , Influenza, Humoral immune response|
|- 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.
1. Age, sex and co-morbidity matched control who has an indication for influenza vaccination.
|- 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.
1. Immunocompromised persons will be excluded (for example immunosuppressive medication).
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-sep-2012|
|- planned closingdate||1-mei-2013|
|- Target number of participants||160|
|- Interventions||Influenza vaccination.|
|- Primary outcome||Percentage responders.|
|- Secondary outcome||Immunesystem components (amount of memory Bcells, lymphocyte sbsets etc).|
|- Timepoints||2-6 months after rituximab treatment or 9-12 months after rituximab treatment.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| M. Rab|
|- CONTACT for SCIENTIFIC QUERIES|| M. Rab|
|- Sponsor/Initiator ||Sint Antonius Ziekenhuis|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rituximab 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)|
|- RECORD||18-nov-2011 - 28-nov-2011|