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

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ClinicalTrials.gov Identifier: NCT01707628
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : January 31, 2014
Sponsor:
Information provided by (Responsible Party):
M. Rab, 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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin Lymphoma (NHL) Biological: influenza vaccination with influenza vaccine Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Response to Influenza Vaccination in Lymphoma Patients Treated With CHOP and Rituximab
Study Start Date : October 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Lymphoma
U.S. FDA Resources

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:
  • Influvac
  • Vaxigrip
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:
  • Influvac
  • Vaxigrip
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:
  • Influvac
  • Vaxigrip



Primary Outcome Measures :
  1. Influenza antibody titre [ Time Frame: 3 weeks after vaccination ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707628


Locations
Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Friesland, Netherlands
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, Netherlands
Onze Lieve Vrouwen Gasthuis
Amsterdam, Noord-Holland, Netherlands
Medisch Spectrum Twente
Enschede, Overrijssel, Netherlands
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3435CM
Reinier de Graaf Groep
Delft, Zuid-Holland, Netherlands
Albert Schweitzer Hospital
Dordrecht, Zuid-Holland, Netherlands
Sponsors and Collaborators
St. Antonius Hospital
Investigators
Principal Investigator: Minke AE Rab, Drs. St. Antonius Hospital

Responsible Party: M. Rab, Drs., St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT01707628     History of Changes
Other Study ID Numbers: NL37320.100.11
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: January 31, 2014
Last Verified: January 2014

Keywords provided by M. Rab, St. Antonius Hospital:
NHL
influenza vaccination
rituximab

Additional relevant MeSH terms:
Lymphoma
Influenza, Human
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antirheumatic Agents