<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/NCT02240316</url>
  </required_header>
  <id_info>
    <org_study_id>ML28886</org_study_id>
    <nct_id>NCT02240316</nct_id>
  </id_info>
  <brief_title>An Observational Study of Patients With Malignant Lymphomas Treated With MabThera® SC in Everyday Clinical Practice</brief_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 observational study aims to assess the therapeutic responsiveness of MabThera SC in&#xD;
      patients with malignant lymphomas under everyday clinical practice conditions. Patients with&#xD;
      previously untreated CD-20 positive follicular non-Hodgkin's lymphoma (NHL) or previously&#xD;
      untreated CD-20 positive diffuse large B-cell lymphoma (DLBCL) who are planned for therapy&#xD;
      with MabThera SC according to the assessment of the physician will be prospectively enrolled&#xD;
      for observation. No study specific measures are required; treatment and documentation will be&#xD;
      performed according to usual clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2014</start_date>
  <completion_date type="Actual">July 22, 2019</completion_date>
  <primary_completion_date type="Actual">July 22, 2019</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>Proportion of patients in both indications (DLBCL and follicular NHL) who have reached a complete remission (CR), including unconfirmed complete remission (CRu)</measure>
    <time_frame>Up to 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total response rate</measure>
    <time_frame>Up to 2.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Two-year progression-free survival rate for patients with follicular lymphoma under maintenance therapy</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety profile: incidence, nature, severity, and outcomes of all adverse events and pregnancies (composite outcome measure)</measure>
    <time_frame>Up to 2.5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">688</enrollment>
  <condition>Lymphoma, B-Cell, Lymphoma, Follicular</condition>
  <arm_group>
    <arm_group_label>Follicular NHL Cohort</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>DLBCL Cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        CD-20 positive, diffuse large cell B-cell non-Hodgkin lymphoma (DLBCL) and CD-20 positive&#xD;
        follicular non-Hodgkin lymphoma (NHL)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women and men aged &gt;=18 years&#xD;
&#xD;
          -  Previously untreated CD-20 positive follicular NHL&#xD;
&#xD;
          -  Previously untreated CD-20 positive DLBCL&#xD;
&#xD;
          -  Planned therapy with MabThera SC according to the assessment of the physician (before&#xD;
             the start and independent from this study)&#xD;
&#xD;
          -  Suitability for the therapy with MabThera SC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        All contraindications, interactions and incompatibilities for therapy with MabThera SC&#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>Universitätsklinikum Essen; Klinik für Hämatologie</name>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>October 29, 2020</last_update_submitted>
  <last_update_submitted_qc>October 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2020</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, B-Cell</mesh_term>
    <mesh_term>Lymphoma, Follicular</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).</ipd_description>
  </patient_data>
  <!-- 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/NCT02240316
org study id: ML28886
nct id: NCT02240316
lead sponsor: 
This observational study aims to assess the therapeutic responsiveness of MabThera SC in
      patients with malignant lymphomas under everyday clinical practice conditions. Patients with
      previously untreated CD-20 positive follicular non-Hodgkin's lymphoma (NHL) or previously
      untreated CD-20 positive diffuse large B-cell lymphoma (DLBCL) who are planned for therapy
      with MabThera SC according to the assessment of the physician will be prospectively enrolled
      for observation. No study specific measures are required; treatment and documentation will be
      performed according to usual clinical practice.
observational model: Cohort
time perspective: Prospective
measure: Proportion of patients in both indications (DLBCL and follicular NHL) who have reached a complete remission (CR), including unconfirmed complete remission (CRu)
time frame: Up to 2 years
measure: Total response rate
time frame: Up to 2.5 years
measure: Two-year progression-free survival rate for patients with follicular lymphoma under maintenance therapy
time frame: 2 years
measure: Safety profile: incidence, nature, severity, and outcomes of all adverse events and pregnancies (composite outcome measure)
time frame: Up to 2.5 years
arm group label: Follicular NHL Cohort
arm group label: DLBCL Cohort
study pop: 
sampling method: Non-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: Germany
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Follicular
sharing ipd: Yes
ipd description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).