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

This study is currently recruiting participants.

Verified December 2012 by St. Antonius Hospital

Sponsor:

Information provided by (Responsible Party):

M. Rab, St. Antonius Hospital

ClinicalTrials.gov Identifier:

NCT01707628

First received: October 6, 2012

Last updated: December 7, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 6, 2012

Last Updated Date

December 7, 2012

Start Date ^ICMJE

October 2012

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01707628 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Response to Influenza Vaccination in Lymphoma Patients Treated With Rituximab

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Non-Hodgkin Lymphoma (NHL)

Intervention ^ICMJE

Biological: influenza vaccination with influenza vaccine

Other Names:

Influvac
Vaxigrip

Study Arm (s)

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

Intervention: 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".

Intervention: Biological: influenza vaccination with influenza vaccine
Active Comparator: Control group
Healthy individuals will be receive vaccination with influenza vaccine and will serve as controls.

Intervention: Biological: influenza vaccination with influenza vaccine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

160

Estimated Completion Date

June 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Minke AE Rab, Drs.	+3188-3203000	m.rab@antoniusziekenhuis.nl
Contact: Okke de Weerdt, Drs.	+31880-3203000	o.weerdt@antoniusziekenhuis.nl

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT01707628

Other Study ID Numbers ^ICMJE

NL37320.100.11

Has Data Monitoring Committee

Responsible Party

M. Rab, St. Antonius Hospital

Study Sponsor ^ICMJE

St. Antonius Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Minke AE Rab, Drs.

St. Antonius Hospital

Information Provided By

St. Antonius Hospital

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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