<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/NCT01684865</url>
  </required_header>
  <id_info>
    <org_study_id>ML27993</org_study_id>
    <nct_id>NCT01684865</nct_id>
  </id_info>
  <brief_title>An Observational Study of First-Line Maintenance Rituximab (MabThera/Rituxan) in Participants With Follicular Non-Hodgkin's Lymphoma</brief_title>
  <official_title>Prospective, Non Interventional Study to Evaluate the Safety Profile of First- Line Rituximab Maintenance Therapy in Patients With Follicular Non-Hodgkin's Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This prospective observational study will evaluate the safety and efficacy of first-line&#xD;
      rituximab maintenance therapy in participants with follicular non-Hodgkin's lymphoma.&#xD;
      Participants initiated on rituximab maintenance therapy according to the standard of care and&#xD;
      in line with the current summary of product characteristics will be followed for a maximum of&#xD;
      3 years or until disease progression occurs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 22, 2012</start_date>
  <completion_date type="Actual">November 27, 2017</completion_date>
  <primary_completion_date type="Actual">November 27, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Adverse Events</measure>
    <time_frame>Baseline up to approximately 3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma</measure>
    <time_frame>Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years])</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Progression, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma</measure>
    <time_frame>Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years])</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Next Anti-Lymphoma Treatment (TTNLT)</measure>
    <time_frame>Baseline up to institution of a new regimen (chemotherapy, radiotherapy or immunotherapy) (up to approximately 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Next Chemotherapy Treatment (TTNCT)</measure>
    <time_frame>Baseline up to institution of a chemotherapy regimen or cytotoxic agent or radio-immunotherapy (up to approximately 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Baseline up to death (up to approximately 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-Free Survival, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma</measure>
    <time_frame>Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years])</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Overall Response of Complete (CR/CRu) or Partial Response, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma</measure>
    <time_frame>Baseline up to disease progression or death (assessed at baseline and every 8 weeks thereafter until disease progression or death [till the end of rituximab maintenance therapy, up to 2 years])</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">22</enrollment>
  <condition>Non-Hodgkin's Lymphoma</condition>
  <arm_group>
    <arm_group_label>Non-Hodgkin's Lymphoma Participants</arm_group_label>
    <description>Participants initiated on rituximab maintenance therapy according to the standard of care and in line with the current summary of product characteristics will receive rituximab for maximum two years or until disease progression. Participants will be followed for one year after last dose of rituximab administered as maintenance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>Due to observational nature of the study protocol does not specify any dosing schedule for rituximab.</description>
    <arm_group_label>Non-Hodgkin's Lymphoma Participants</arm_group_label>
    <other_name>MabThera®, Rituxan®</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with follicular non-Hodgkin's lymphoma receiving first-line rituximab&#xD;
        maintenance treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological diagnosis of follicular non-Hodgkin's lymphoma&#xD;
&#xD;
          -  Complete or partial response to first-line induction therapy with chemotherapy with&#xD;
             rituximab&#xD;
&#xD;
          -  Participants about to receive first-line rituximab maintenance treatment for&#xD;
             follicular non-Hodgkin's lymphoma according to the local label&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Receipt of an investigational drug within 30 days prior to initiation of observational&#xD;
             drug&#xD;
&#xD;
          -  Any medical or psychological alteration that, to criterion of the investigator, can&#xD;
             jeopardize the capacity of the participant to grant informed consent&#xD;
&#xD;
          -  Central nervous system involvement&#xD;
&#xD;
          -  Hepatitis B or C virus infection or human immunodeficiency virus infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Clinic of Hematology Skopje, Hospital Care Department</name>
      <address>
        <city>Skopje</city>
        <zip>1000</zip>
        <country>Macedonia, The Former Yugoslav Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Macedonia, The Former Yugoslav Republic of</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>December 28, 2017</last_update_submitted>
  <last_update_submitted_qc>December 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Lymphoma, Follicular</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rituximab</mesh_term>
  </intervention_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/NCT01684865
org study id: ML27993
nct id: NCT01684865
lead sponsor: 
This prospective observational study will evaluate the safety and efficacy of first-line
      rituximab maintenance therapy in participants with follicular non-Hodgkin's lymphoma.
      Participants initiated on rituximab maintenance therapy according to the standard of care and
      in line with the current summary of product characteristics will be followed for a maximum of
      3 years or until disease progression occurs.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants With Adverse Events
time frame: Baseline up to approximately 3 years
measure: Progression-Free Survival, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma
time frame: Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years])
measure: Time to Progression, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma
time frame: Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years])
measure: Time to Next Anti-Lymphoma Treatment (TTNLT)
time frame: Baseline up to institution of a new regimen (chemotherapy, radiotherapy or immunotherapy) (up to approximately 3 years)
measure: Time to Next Chemotherapy Treatment (TTNCT)
time frame: Baseline up to institution of a chemotherapy regimen or cytotoxic agent or radio-immunotherapy (up to approximately 3 years)
measure: Overall Survival
time frame: Baseline up to death (up to approximately 3 years)
measure: Event-Free Survival, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma
time frame: Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years])
measure: Percentage of Participants with Overall Response of Complete (CR/CRu) or Partial Response, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma
time frame: Baseline up to disease progression or death (assessed at baseline and every 8 weeks thereafter until disease progression or death [till the end of rituximab maintenance therapy, up to 2 years])
arm group label: Non-Hodgkin's Lymphoma Participants
description: Participants initiated on rituximab maintenance therapy according to the standard of care and in line with the current summary of product characteristics will receive rituximab for maximum two years or until disease progression. Participants will be followed for one year after last dose of rituximab administered as maintenance.
intervention type: Drug
intervention name: Rituximab
description: Due to observational nature of the study protocol does not specify any dosing schedule for rituximab.
arm group label: Non-Hodgkin's Lymphoma Participants
other name: MabThera®, Rituxan®
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
country: Macedonia, The Former Yugoslav Republic of
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Lymphoma, Follicular
mesh term: Rituximab