Response to Influenza Vaccination in Lymphoma Patients Treated With Rituximab

Non-Hodgkin Lymphoma (NHL) Clinical Trial

— Rituxivac  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707628
• Other study ID #: NL37320.100.11
• Status: Completed
• Phase: N/A
• First received: October 6, 2012
• Last updated: January 30, 2014
• Start date: October 2012
• Est. completion date: June 2013

Study information

• Verified date: January 2014
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma (NHL)

Intervention

Biological:
• influenza vaccination with influenza vaccine

Locations

Country	Name	City	State
Netherlands	Onze Lieve Vrouwen Gasthuis	Amsterdam	Noord-Holland
Netherlands	Reinier de Graaf Groep	Delft	Zuid-Holland
Netherlands	Albert Schweitzer Hospital	Dordrecht	Zuid-Holland
Netherlands	Medisch Spectrum Twente	Enschede	Overrijssel
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden	Friesland
Netherlands	St. Antonius Hospital	Nieuwegein	Utrecht
Netherlands	Canisius Wilhelmina Hospital	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influenza antibody titre		3 weeks after vaccination	No
Secondary	number of memory B cells		6 months	No
Secondary	lymphocyte subsets		6 months	No
Secondary	immunoglobulin levels		6 months	No
Secondary	IgG subclasses		6 months	No
Secondary	production of IFN-? by CD4+ cells		6 months	No
Secondary	Cytokines		6 months	No
Secondary	genetic factors		6 months	No