NCT01707628

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 31, 2014

Status Verified

January 1, 2014

Enrollment Period

8 months

First QC Date

October 6, 2012

Last Update Submit

January 30, 2014

Conditions

Non-Hodgkin Lymphoma (NHL)

Keywords

NHLinfluenza vaccinationrituximab

Outcome Measures

Primary Outcomes (1)

  • Influenza antibody titre

    3 weeks after vaccination

Secondary Outcomes (7)

  • number of memory B cells

    6 months

  • lymphocyte subsets

    6 months

  • immunoglobulin levels

    6 months

  • IgG subclasses

    6 months

  • production of IFN-γ by CD4+ cells

    6 months

  • +2 more secondary outcomes

Study Arms (3)

Early group after rituximab

ACTIVE COMPARATOR

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

Biological: influenza vaccination with influenza vaccine

Late group after rituximab

ACTIVE COMPARATOR

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

Biological: influenza vaccination with influenza vaccine

Control group

ACTIVE COMPARATOR

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

Biological: influenza vaccination with influenza vaccine

Interventions

influenza vaccination with influenza vaccineBIOLOGICAL
Also known as: Influvac, Vaxigrip
Control groupEarly group after rituximabLate group after rituximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Canisius Wilhelmina Hospital

Nijmegen, Gelderland, Netherlands

Location

Onze Lieve Vrouwen Gasthuis

Amsterdam, North Holland, Netherlands

Location

Medisch Spectrum Twente

Enschede, Overrijssel, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, Netherlands

Location

Reinier de Graaf Groep

Delft, South Holland, Netherlands

Location

Albert Schweitzer Hospital

Dordrecht, South Holland, Netherlands

Location

St. Antonius Hospital

Nieuwegein, Utrecht, 3435CM, Netherlands

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinInfluenza, Human

Interventions

Influenza Vaccinesinfluvacvaxigrip

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesRespiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Minke AE Rab, Drs.

    St. Antonius Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Drs.

Study Record Dates

First Submitted

October 6, 2012

First Posted

October 16, 2012

Study Start

October 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

January 31, 2014

Record last verified: 2014-01

Locations

NL(7)