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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M. Rab, St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT01707628
First received: October 6, 2012
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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 Intervention
Non-Hodgkin Lymphoma (NHL)
Biological: influenza vaccination with influenza vaccine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Response to Influenza Vaccination in Lymphoma Patients Treated With CHOP and Rituximab

Resource links provided by NLM:


Further study details as provided by St. Antonius Hospital:

Primary Outcome Measures:
  • Influenza antibody titre [ Time Frame: 3 weeks after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of memory B cells [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • lymphocyte subsets [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • immunoglobulin levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • IgG subclasses [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • production of IFN-γ by CD4+ cells [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Cytokines [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • genetic factors [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: October 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: M. Rab, Drs., St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT01707628     History of Changes
Other Study ID Numbers: NL37320.100.11
Study First Received: October 6, 2012
Last Updated: January 30, 2014
Health Authority: The Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 19, 2014