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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01707628
First Posted: October 16, 2012
Last Update Posted: January 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
M. Rab, St. Antonius Hospital
October 6, 2012
October 16, 2012
January 31, 2014
October 2012
June 2013   (Final data collection date for primary outcome measure)
Influenza antibody titre [ Time Frame: 3 weeks after vaccination ]
Same as current
Complete list of historical versions of study NCT01707628 on ClinicalTrials.gov Archive Site
  • number of memory B cells [ Time Frame: 6 months ]
  • lymphocyte subsets [ Time Frame: 6 months ]
  • immunoglobulin levels [ Time Frame: 6 months ]
  • IgG subclasses [ Time Frame: 6 months ]
  • production of IFN-γ by CD4+ cells [ Time Frame: 6 months ]
  • Cytokines [ Time Frame: 6 months ]
  • genetic factors [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
Response to Influenza Vaccination in Lymphoma Patients Treated With Rituximab
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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Non-Hodgkin Lymphoma (NHL)
Biological: influenza vaccination with influenza vaccine
Other Names:
  • Influvac
  • Vaxigrip
  • Active Comparator: Early group after rituximab
    Patients who received rituximab last dose 3-6 months before influenza vaccination will be the "early group".
    Intervention: Biological: influenza vaccination with influenza vaccine
  • Active Comparator: Late group after rituximab
    Patients who received rituximab last dose 9-12 months before influenza vaccination will be the "late group".
    Intervention: Biological: influenza vaccination with influenza vaccine
  • Active Comparator: Control group
    Healthy individuals will be receive vaccination with influenza vaccine and will serve as controls.
    Intervention: Biological: influenza vaccination with influenza vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
June 2013
June 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01707628
NL37320.100.11
No
Not Provided
Not Provided
M. Rab, St. Antonius Hospital
St. Antonius Hospital
Not Provided
Principal Investigator: Minke AE Rab, Drs. St. Antonius Hospital
St. Antonius Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP