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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01707628 |
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Date of registration:
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06/10/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Response to Influenza Vaccination in Lymphoma Patients Treated With Rituximab
Rituxivac |
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Scientific title:
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Response to Influenza Vaccination in Lymphoma Patients Treated With CHOP and Rituximab |
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Date of first enrolment:
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October 2012 |
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Target sample size:
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98 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01707628 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Minke AE Rab, Drs. |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Antonius Hospital |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non-Hodgkin Lymphoma (NHL)
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Intervention(s)
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Biological: influenza vaccination with influenza vaccine
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Primary Outcome(s)
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Influenza antibody titre
[Time Frame: 3 weeks after vaccination]
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Secondary Outcome(s)
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IgG subclasses
[Time Frame: 6 months]
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lymphocyte subsets
[Time Frame: 6 months]
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immunoglobulin levels
[Time Frame: 6 months]
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Cytokines
[Time Frame: 6 months]
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production of IFN-? by CD4+ cells
[Time Frame: 6 months]
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genetic factors
[Time Frame: 6 months]
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number of memory B cells
[Time Frame: 6 months]
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Secondary ID(s)
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NL37320.100.11
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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