Response to Influenza Vaccination in Lymphoma Patients Treated With Rituximab

Not Applicable

Completed

• Conditions: Non-Hodgkin Lymphoma (NHL)
• Interventions: Biological: influenza vaccination with influenza vaccine

• Registration Number: NCT01707628
• Lead Sponsor: St. Antonius Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-06
• Study First Submitted QC: 2012-10-14
• Study First Posted: 2012-10-16
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-30
• Last Update Posted: 2014-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Early group after rituximab	influenza vaccination with influenza vaccine	Patients who received rituximab last dose 3-6 months before influenza vaccination will be the "early group".
Late group after rituximab	influenza vaccination with influenza vaccine	Patients who received rituximab last dose 9-12 months before influenza vaccination will be the "late group".
Control group	influenza vaccination with influenza vaccine	Healthy individuals will be receive vaccination with influenza vaccine and will serve as controls.

Primary Outcome Measures

Name	Time	Method
Influenza antibody titre	3 weeks after vaccination

Secondary Outcome Measures

Name	Time	Method
immunoglobulin levels	6 months
IgG subclasses	6 months
production of IFN-γ by CD4+ cells	6 months
Cytokines	6 months
genetic factors	6 months
lymphocyte subsets	6 months
number of memory B cells	6 months

Trial Locations

Locations (7)

Albert Schweitzer Hospital; 🇳🇱 Dordrecht, Zuid-Holland, Netherlands

Onze Lieve Vrouwen Gasthuis; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Overrijssel, Netherlands

Medisch Centrum Leeuwarden; 🇳🇱 Leeuwarden, Friesland, Netherlands

Reinier de Graaf Groep; 🇳🇱 Delft, Zuid-Holland, Netherlands

Canisius Wilhelmina Hospital; 🇳🇱 Nijmegen, Gelderland, Netherlands

St. Antonius Hospital; 🇳🇱 Nieuwegein, Utrecht, Netherlands