Non-Hodgkin Lymphoma (NHL)RituxivacNCT01707628
Response to Influenza Vaccination in Lymphoma Patients Treated With Rituximab
A study testing influenza vaccination with influenza vaccine in people with Non-Hodgkin Lymphoma (NHL), run by St. Antonius Hospital at 7 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-Hodgkin Lymphoma (NHL)
- What is being tested?
- influenza vaccination with influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 7 sitesNetherlands
- Study dates
- Oct 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Netherlands7 sites
Onze Lieve Vrouwen Gasthuis
Amsterdam, North Holland
Reinier de Graaf Groep
Delft, South Holland
Albert Schweitzer Hospital
Dordrecht, South Holland
Medisch Spectrum Twente
Enschede, Overrijssel
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland
St. Antonius Hospital
Nieuwegein, Utrecht, 3435CM
Canisius Wilhelmina Hospital
Nijmegen, Gelderland
About this study
Official title: Response to Influenza Vaccination in Lymphoma Patients Treated With CHOP and Rituximab
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.
- Conditions
- Non-Hodgkin Lymphoma (NHL)
- Being tested
- influenza vaccination with influenza vaccine
- Keywords
- NHL, influenza vaccination, rituximab
- Medical subject headings
- Lymphoma, Non-Hodgkin, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
influenza vaccination with influenza vaccineBiological
Also called Influvac, Vaxigrip
| Study group | Role | What they receive |
|---|---|---|
| Early group after rituximab | Active comparator | Patients who received rituximab last dose 3-6 months before influenza vaccination will be the "early group". Receives: 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". Receives: Biological: influenza vaccination with influenza vaccine |
| Control group | Active comparator | Healthy individuals will be receive vaccination with influenza vaccine and will serve as controls. Receives: Biological: influenza vaccination with influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza antibody titre
Measured: 3 weeks after vaccination
Secondary outcomes (7)
number of memory B cells
Measured: 6 months
lymphocyte subsets
Measured: 6 months
immunoglobulin levels
Measured: 6 months
IgG subclasses
Measured: 6 months
production of IFN-γ by CD4+ cells
Measured: 6 months
Cytokines
Measured: 6 months
genetic factors
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin Lymphoma (NHL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Rab, St. Antonius Hospital
- Investigators
- Minke AE Rab, Drs., Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707628
- Sponsor's protocol ID
- NL37320.100.11
- Acronym
- Rituxivac
- Status last verified
- Jan 2014
- First submitted
- 6 Oct 2012
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to Influenza Vaccination in Lymphoma Patients Treated With CHOP and Rituximab
- ClinicalTrials.gov ID
- NCT01707628
- Acronym / sponsor ID
- Rituxivac / NL37320.100.11
- Conditions
- Non-Hodgkin Lymphoma (NHL)
- Keywords
- NHL, influenza vaccination, rituximab
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early group after rituximab | Active comparator | Biological: influenza vaccination with influenza vaccinePatients who received rituximab last dose 3-6 months before influenza vaccination will be the "early group". |
| Late group after rituximab | Active comparator | Biological: influenza vaccination with influenza vaccinePatients who received rituximab last dose 9-12 months before influenza vaccination will be the "late group". |
| Control group | Active comparator | Biological: influenza vaccination with influenza vaccineHealthy individuals will be receive vaccination with influenza vaccine and will serve as controls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| influenza vaccination with influenza vaccineAlso: Influvac, Vaxigrip | Biological | Control group, Early group after rituximab, Late group after rituximab |
Primary outcome
Influenza antibody titre
Time frame: 3 weeks after vaccination
7 secondary outcomes
number of memory B cells
Time frame: 6 months
lymphocyte subsets
Time frame: 6 months
immunoglobulin levels
Time frame: 6 months
IgG subclasses
Time frame: 6 months
production of IFN-γ by CD4+ cells
Time frame: 6 months
Cytokines
Time frame: 6 months
genetic factors
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minke AE Rab, Drs. principal investigator
St. Antonius Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing influenza vaccination with influenza vaccine in people with Non-Hodgkin Lymphoma (NHL), run by St. Antonius Hospital at 7 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influenza antibody titre (time frame: 3 weeks after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2014.