<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01707628</url>
  </required_header>
  <id_info>
    <org_study_id>NL37320.100.11</org_study_id>
    <nct_id>NCT01707628</nct_id>
  </id_info>
  <brief_title>Response to Influenza Vaccination in Lymphoma Patients Treated With Rituximab</brief_title>
  <acronym>Rituxivac</acronym>
  <official_title>Response to Influenza Vaccination in Lymphoma Patients Treated With CHOP and Rituximab</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Antonius Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Antonius Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the number of responders to vaccination with the&#xD;
      influenza virus vaccine at different time points after last dose of rituximab in patients&#xD;
      with lymphoma. Secondly to study the immune-response to vaccination with influenza virus&#xD;
      vaccine, after treatment with rituximab in relation to the reconstitution of immune-function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Influenza antibody titre</measure>
    <time_frame>3 weeks after vaccination</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of memory B cells</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>lymphocyte subsets</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>immunoglobulin levels</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IgG subclasses</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>production of IFN-γ by CD4+ cells</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokines</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>genetic factors</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">98</enrollment>
  <condition>Non-Hodgkin Lymphoma (NHL)</condition>
  <arm_group>
    <arm_group_label>Early group after rituximab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who received rituximab last dose 3-6 months before influenza vaccination will be the &quot;early group&quot;.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late group after rituximab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who received rituximab last dose 9-12 months before influenza vaccination will be the &quot;late group&quot;.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy individuals will be receive vaccination with influenza vaccine and will serve as controls.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>influenza vaccination with influenza vaccine</intervention_name>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Early group after rituximab</arm_group_label>
    <arm_group_label>Late group after rituximab</arm_group_label>
    <other_name>Influvac</other_name>
    <other_name>Vaxigrip</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with non-Hodgkin's lymphoma, treated with rituximab (with a range of 6-12&#xD;
             cycles) and who are in remission.&#xD;
&#xD;
          2. Completion of rituximab therapy in the last twelve months before start of the study.&#xD;
&#xD;
          3. Age ≥ 18 years.&#xD;
&#xD;
          4. Signing of informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Completion of rituximab therapy 7-8 months before start of the study.&#xD;
&#xD;
          2. Fever at time of vaccination.&#xD;
&#xD;
          3. Previous/known allergic reaction to any of the components of the vaccines given.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Minke AE Rab, Drs.</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Antonius Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medisch Centrum Leeuwarden</name>
      <address>
        <city>Leeuwarden</city>
        <state>Friesland</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Canisius Wilhelmina Hospital</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onze Lieve Vrouwen Gasthuis</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord-Holland</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Spectrum Twente</name>
      <address>
        <city>Enschede</city>
        <state>Overrijssel</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Antonius Hospital</name>
      <address>
        <city>Nieuwegein</city>
        <state>Utrecht</state>
        <zip>3435CM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reinier de Graaf Groep</name>
      <address>
        <city>Delft</city>
        <state>Zuid-Holland</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Schweitzer Hospital</name>
      <address>
        <city>Dordrecht</city>
        <state>Zuid-Holland</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>October 6, 2012</study_first_submitted>
  <study_first_submitted_qc>October 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>January 30, 2014</last_update_submitted>
  <last_update_submitted_qc>January 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Antonius Hospital</investigator_affiliation>
    <investigator_full_name>M. Rab</investigator_full_name>
    <investigator_title>Drs.</investigator_title>
  </responsible_party>
  <keyword>NHL</keyword>
  <keyword>influenza vaccination</keyword>
  <keyword>rituximab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01707628
org study id: NL37320.100.11
nct id: NCT01707628
lead sponsor: 
has dmc: No
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.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Influenza antibody titre
time frame: 3 weeks after vaccination
measure: number of memory B cells
time frame: 6 months
measure: lymphocyte subsets
time frame: 6 months
measure: immunoglobulin levels
time frame: 6 months
measure: IgG subclasses
time frame: 6 months
measure: production of IFN-γ by CD4+ cells
time frame: 6 months
measure: Cytokines
time frame: 6 months
measure: genetic factors
time frame: 6 months
arm group label: Early group after rituximab
arm group type: Active Comparator
description: Patients who received rituximab last dose 3-6 months before influenza vaccination will be the "early group".
arm group label: Late group after rituximab
arm group type: Active Comparator
description: Patients who received rituximab last dose 9-12 months before influenza vaccination will be the "late group".
arm group label: Control group
arm group type: Active Comparator
description: Healthy individuals will be receive vaccination with influenza vaccine and will serve as controls.
intervention type: Biological
intervention name: influenza vaccination with influenza vaccine
arm group label: Control group
arm group label: Early group after rituximab
arm group label: Late group after rituximab
other name: Influvac
other name: Vaxigrip
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Minke AE Rab, Drs.
role: Principal Investigator
affiliation: St. Antonius Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: St. Antonius Hospital
investigator full name: M. Rab
investigator title: Drs.
mesh term: Influenza, Human
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin