Response to Influenza Vaccination in Lymphoma Patients Treated With Rituximab (Rituxivac)

January 30, 2014 updated by: M. Rab, St. Antonius Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Friesland
      • Leeuwarden, Friesland, Netherlands
        • Medisch Centrum Leeuwarden
    • Gelderland
      • Nijmegen, Gelderland, Netherlands
        • Canisius Wilhelmina Hospital
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands
        • Onze Lieve Vrouwen Gasthuis
    • Overrijssel
      • Enschede, Overrijssel, Netherlands
        • Medisch Spectrum Twente
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3435CM
        • St. Antonius Hospital
    • Zuid-Holland
      • Delft, Zuid-Holland, Netherlands
        • Reinier de Graaf Groep
      • Dordrecht, Zuid-Holland, Netherlands
        • Albert Schweitzer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Influenza antibody titre
Time Frame: 3 weeks after vaccination
3 weeks after vaccination

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Antonius Hospital

Investigators

  • Principal Investigator: Minke AE Rab, Drs., St. Antonius Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

October 6, 2012

First Submitted That Met QC Criteria

October 14, 2012

First Posted (Estimate)

October 16, 2012

Study Record Updates

Last Update Posted (Estimate)

January 31, 2014

Last Update Submitted That Met QC Criteria

January 30, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL37320.100.11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-Hodgkin Lymphoma (NHL)

Clinical Trials on influenza vaccination with influenza vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe