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

Primary Purpose

Non-Hodgkin Lymphoma (NHL)

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
influenza vaccination with influenza vaccine
Sponsored by
St. Antonius Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-Hodgkin Lymphoma (NHL) focused on measuring NHL, influenza vaccination, rituximab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Medisch Centrum Leeuwarden
  • Canisius Wilhelmina Hospital
  • Onze Lieve Vrouwen Gasthuis
  • Medisch Spectrum Twente
  • St. Antonius Hospital
  • Reinier de Graaf Groep
  • Albert Schweitzer Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Early group after rituximab

Late group after rituximab

Control group

Arm Description

Patients who received rituximab last dose 3-6 months before influenza vaccination will be the "early group".

Patients who received rituximab last dose 9-12 months before influenza vaccination will be the "late group".

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

Outcomes

Primary Outcome Measures

Influenza antibody titre

Secondary Outcome Measures

number of memory B cells
lymphocyte subsets
immunoglobulin levels
IgG subclasses
production of IFN-γ by CD4+ cells
Cytokines
genetic factors

Full Information

First Posted
October 6, 2012
Last Updated
January 30, 2014
Sponsor
St. Antonius Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01707628
Brief Title
Response to Influenza Vaccination in Lymphoma Patients Treated With Rituximab
Acronym
Rituxivac
Official Title
Response to Influenza Vaccination in Lymphoma Patients Treated With CHOP and Rituximab
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Antonius Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma (NHL)
Keywords
NHL, influenza vaccination, rituximab

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early group after rituximab
Arm Type
Active Comparator
Arm Description
Patients who received rituximab last dose 3-6 months before influenza vaccination will be the "early group".
Arm Title
Late group after rituximab
Arm Type
Active Comparator
Arm Description
Patients who received rituximab last dose 9-12 months before influenza vaccination will be the "late group".
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Healthy individuals will be receive vaccination with influenza vaccine and will serve as controls.
Intervention Type
Biological
Intervention Name(s)
influenza vaccination with influenza vaccine
Other Intervention Name(s)
Influvac, Vaxigrip
Primary Outcome Measure Information:
Title
Influenza antibody titre
Time Frame
3 weeks after vaccination
Secondary Outcome Measure Information:
Title
number of memory B cells
Time Frame
6 months
Title
lymphocyte subsets
Time Frame
6 months
Title
immunoglobulin levels
Time Frame
6 months
Title
IgG subclasses
Time Frame
6 months
Title
production of IFN-γ by CD4+ cells
Time Frame
6 months
Title
Cytokines
Time Frame
6 months
Title
genetic factors
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minke AE Rab, Drs.
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
State/Province
Friesland
Country
Netherlands
Facility Name
Canisius Wilhelmina Hospital
City
Nijmegen
State/Province
Gelderland
Country
Netherlands
Facility Name
Onze Lieve Vrouwen Gasthuis
City
Amsterdam
State/Province
Noord-Holland
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
State/Province
Overrijssel
Country
Netherlands
Facility Name
St. Antonius Hospital
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3435CM
Country
Netherlands
Facility Name
Reinier de Graaf Groep
City
Delft
State/Province
Zuid-Holland
Country
Netherlands
Facility Name
Albert Schweitzer Hospital
City
Dordrecht
State/Province
Zuid-Holland
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Response to Influenza Vaccination in Lymphoma Patients Treated With Rituximab

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