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:
St. Antonius Hospital
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Non-Hodgkin Lymphoma (NHL) |
Biological: influenza vaccination with influenza vaccine |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Response to Influenza Vaccination in Lymphoma Patients Treated With CHOP and Rituximab |
Resource links provided by NLM:
Further study details as provided by St. Antonius Hospital:
Primary Outcome Measures:
- Influenza antibody titre [ Time Frame: 3 weeks after vaccination ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 160 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Early group after rituximab
Patients who received rituximab last dose 3-6 months before influenza vaccination will be the "early group".
|
Biological: influenza vaccination with influenza vaccine
Other Names:
|
|
Active Comparator: Late group after rituximab
Patients who received rituximab last dose 9-12 months before influenza vaccination will be the "late group".
|
Biological: influenza vaccination with influenza vaccine
Other Names:
|
|
Active Comparator: Control group
Healthy individuals will be receive vaccination with influenza vaccine and will serve as controls.
|
Biological: influenza vaccination with influenza vaccine
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707628
Contacts
| Contact: Minke AE Rab, Drs. | +3188-3203000 | m.rab@antoniusziekenhuis.nl |
| Contact: Okke de Weerdt, Drs. | +31880-3203000 | o.weerdt@antoniusziekenhuis.nl |
Locations
| Netherlands | |
| Medisch Centrum Leeuwarden | Recruiting |
| Leeuwarden, Friesland, Netherlands | |
| Contact: Carla Wassenaar +3158 2866279 c.wassenaar@znb.nl | |
| Sub-Investigator: Mels Hoogendoorn, Dr. | |
| Canisius Wilhelmina Hospital | Recruiting |
| Nijmegen, Gelderland, Netherlands | |
| Contact: Caroline M Mandigers, Dr. +3124-3658788 c.mandigers@cwz.nl | |
| Contact: Hanneke Walthaus +3124-3658788 h.walthaus@cwz.nl | |
| Sub-Investigator: Caroline M Mandigers, Dr. | |
| Onze Lieve Vrouwen Gasthuis | Recruiting |
| Amsterdam, Noord-Holland, Netherlands | |
| Contact: Judith Westra +3120-5992674 j.westra@olvg.nl | |
| Sub-Investigator: Onno C Leeksma, Dr. | |
| Medisch Spectrum Twente | Recruiting |
| Enschede, Overrijssel, Netherlands | |
| Contact: Tineke Duyts +3153 4872440 a.duyts@mst.nl | |
| Sub-Investigator: Martijn R Schaafsma, Dr. | |
| St. Antonius Hospital | Recruiting |
| Nieuwegein, Utrecht, Netherlands, 3435CM | |
| Contact: Minke AE Rab, Drs m.rab@antoniusziekenhuis.nl | |
| Principal Investigator: Minke AE Rab, Drs. | |
| Reinier de Graaf Groep | Recruiting |
| Delft, Zuid-Holland, Netherlands | |
| Contact: Edith van Druten +3115-2603482 druten@rdgg.nl | |
| Sub-Investigator: Rolf E Brouwer, Dr. | |
| Albert Schweitzer Hospital | Recruiting |
| Dordrecht, Zuid-Holland, Netherlands | |
| Contact: Sylvia Sprangers-Van Campen +3178-6542274 s.sprangers@asz.nl | |
| Sub-Investigator: Mark-David Levin, Dr. | |
Sponsors and Collaborators
St. Antonius Hospital
Investigators
| Principal Investigator: | Minke AE Rab, Drs. | St. Antonius Hospital |
More Information
No publications provided
| Responsible Party: | M. Rab, Drs., St. Antonius Hospital |
| ClinicalTrials.gov Identifier: | NCT01707628 History of Changes |
| Other Study ID Numbers: | NL37320.100.11 |
| Study First Received: | October 6, 2012 |
| Last Updated: | December 7, 2012 |
| Health Authority: | The Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by St. Antonius Hospital:
|
NHL influenza vaccination rituximab |
Additional relevant MeSH terms:
|
Influenza, Human Lymphoma Lymphoma, Non-Hodgkin Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013