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CompletedNCT01707628RituxivacUpdated Jan 31, 2014

Response to Influenza Vaccination in Lymphoma Patients Treated With Rituximab

An interventional study of influenza vaccination with influenza vaccine in Non-Hodgkin Lymphoma (NHL), sponsored by St. Antonius Hospital. Completed at 7 sites in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-31.

Sponsored by St. Antonius Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
98
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Non-Hodgkin Lymphoma (NHL)

Keywords

  • NHL
  • influenza vaccination
  • rituximab
03

In context

Lymphoma, Non-Hodgkin

2,043 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 309 are open to participants now.

This study's enrollment of 98 is above the median of 40 across 1,744 interventional studies indexed under Lymphoma, Non-Hodgkin.

Browse Lymphoma, Non-Hodgkin studies →

Lead sponsor

St. Antonius Hospital is the lead sponsor of 97 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
98 participants (actual)

Study arms

  • 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

  • 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

  • Active comparator
    Control group

    Healthy individuals will be receive vaccination with influenza vaccine and will serve as controls.

    Biological: influenza vaccination with influenza vaccine

Interventions

  • Biologicalinfluenza vaccination with influenza vaccine

    Also known as: Influvac, Vaxigrip

06

What researchers measure

Primary outcomes

  1. Influenza antibody titre

    Time frame: 3 weeks after vaccination

Secondary outcomes

  1. number of memory B cells

    Time frame: 6 months

  2. lymphocyte subsets

    Time frame: 6 months

  3. immunoglobulin levels

    Time frame: 6 months

  4. IgG subclasses

    Time frame: 6 months

  5. production of IFN-γ by CD4+ cells

    Time frame: 6 months

  6. Cytokines

    Time frame: 6 months

  7. genetic factors

    Time frame: 6 months

07

Study locations

7 sites
  • Canisius Wilhelmina Hospital
    Nijmegen, Gelderland, Netherlands
  • Onze Lieve Vrouwen Gasthuis
    Amsterdam, North Holland, Netherlands
  • Medisch Spectrum Twente
    Enschede, Overrijssel, Netherlands
  • Medisch Centrum Leeuwarden
    Leeuwarden, Provincie Friesland, Netherlands
  • Reinier de Graaf Groep
    Delft, South Holland, Netherlands
  • Albert Schweitzer Hospital
    Dordrecht, South Holland, Netherlands
  • St. Antonius Hospital
    Nieuwegein, Utrecht 3435CM, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01707628
Lead sponsor
St. Antonius Hospital
Responsible party
M. Rab (Drs., St. Antonius Hospital) — Principal investigator
First posted
Oct 16, 2012
Start date
Oct 2012
Primary completion
Jun 2013
Completion
Jun 2013
Last update
Jan 31, 2014

Study contacts

Minke AE Rab, Drs.
principal investigator · St. Antonius Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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