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Completed

NCT Number: NCT01707628

Response to Influenza Vaccination in Lymphoma Patients Treated With 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.

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Key information

Conditions

Non-Hodgkin Lymphoma (NHL) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Infections Influenza, Human Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canisius Wilhelmina Hospital, Nijmegen, Gelderland, Netherlands

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with non-Hodgkin's lymphoma, treated with rituximab (with a range of 6-12 cycles) and who are in remission.
  • Completion of rituximab therapy in the last twelve months before start of the study.
  • Age ≥ 18 years.
  • Signing of informed consent.

Exclusion criteria

  • Completion of rituximab therapy 7-8 months before start of the study.
  • Fever at time of vaccination.
  • Previous/known allergic reaction to any of the components of the vaccines given.

Treatment and study plan

influenza vaccination with influenza vaccine

Biological

Other names: Influvac, Vaxigrip

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

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Official study title

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

Acronym: Rituxivac

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 16, 2012
Registry last updated
Jan 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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