Response to Influenza Vaccination in Lymphoma Patients Treated With Rituximab

NCT ID: NCT01707628

Last Updated: 2014-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Hodgkin Lymphoma (NHL)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

NHL influenza vaccination rituximab

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Early group after rituximab

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

Group Type ACTIVE_COMPARATOR

influenza vaccination with influenza vaccine

Intervention Type BIOLOGICAL

Late group after rituximab

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

Group Type ACTIVE_COMPARATOR

influenza vaccination with influenza vaccine

Intervention Type BIOLOGICAL

Control group

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

Group Type ACTIVE_COMPARATOR

influenza vaccination with influenza vaccine

Intervention Type BIOLOGICAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

influenza vaccination with influenza vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Influvac Vaxigrip

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Antonius Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

M. Rab

Drs.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Minke AE Rab, Drs.

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Canisius Wilhelmina Hospital

Nijmegen, Gelderland, Netherlands

Site Status

Onze Lieve Vrouwen Gasthuis

Amsterdam, North Holland, Netherlands

Site Status

Medisch Spectrum Twente

Enschede, Overrijssel, Netherlands

Site Status

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, Netherlands

Site Status

Reinier de Graaf Groep

Delft, South Holland, Netherlands

Site Status

Albert Schweitzer Hospital

Dordrecht, South Holland, Netherlands

Site Status

St. Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NL37320.100.11

Identifier Type: -

Identifier Source: org_study_id