<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/NCT02199288</url>
  </required_header>
  <id_info>
    <org_study_id>ML29314</org_study_id>
    <nct_id>NCT02199288</nct_id>
  </id_info>
  <brief_title>Effectiveness, Safety &amp; Nurse Management Study of MabThera SC in Patients With Non-Hodgkin's Lymphoma: Real-Life Setting</brief_title>
  <official_title>A NON-INTERVENTIONAL STUDY TO EVALUATE THE EFFECTIVENESS, SAFETY AND NURSE MANAGEMENT DURING INDUCTION TREATMENT WITH MABTHERA S.C. FOLLOWING A FIRST INITIAL MABTHERA I.V. TREATMENT, IN PATIENTS WITH NON-HODGKINS LYMPHOMA IN A REAL-LIFE SETTING</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, open-label, multicenter, observational study will investigate the&#xD;
      effectiveness and safety of MabThera SC (rituximab, subcutaneous) induction therapy in&#xD;
      patients with non-Hodgkin's lymphoma, following a first initial treatment of MabThera IV&#xD;
      (rituximab, intraveneous). Induction treatment period in the study is estimated to be 8&#xD;
      months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Response rate using the International Working Group criteria</measure>
    <time_frame>8 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Through to end of study, up to approximately 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of administration related reactions during induction therapy in patients who have previously received at least one dose of MabThera IV</measure>
    <time_frame>Through to end of study, up to approximately 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of serious adverse events</measure>
    <time_frame>Through to end of study, up to approximately 1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">54</enrollment>
  <condition>Non-Hodgkin's Lymphoma</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients within label indication for MabThera SC and subject for induction therapy with&#xD;
        MabThera SC; patients object for maintenance therapy are excluded&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Indication according to the Summary of Product Characteristics (SPC) for MabThera SC&#xD;
             formulation:&#xD;
&#xD;
               -  As treatment of previously untreated patients with stage III-IV follicular&#xD;
                  lymphoma in combination with chemotherapy&#xD;
&#xD;
               -  As treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's&#xD;
                  lymphoma in combination with chemotherapy&#xD;
&#xD;
          2. At least 4 treatment cycles with MabThera is planned&#xD;
&#xD;
          3. Patients &gt;/= 18 years at inclusion&#xD;
&#xD;
          4. Patients written informed consent&#xD;
&#xD;
          5. Treatment decision to prescribe MabThera SC has been taken by the physician prior to&#xD;
             recruitment into the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindications according to SPC for MabThera SC formulation:&#xD;
&#xD;
               -  Hypersensitivity for the active substance or murine antibodies, hyaluronidase or&#xD;
                  any other excipients&#xD;
&#xD;
               -  Active and severe infections&#xD;
&#xD;
               -  Patients with severe immunsuppression&#xD;
&#xD;
          2. Patient included in clinical trials with experimental pharmaceuticals&#xD;
&#xD;
          3. Pregnancy&#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>
      <address>
        <city>Eskilstuna</city>
        <zip>63188</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Halmstad</city>
        <zip>301 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Helsingborg</city>
        <zip>25187</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Linkoeping</city>
        <zip>581 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Luleå</city>
        <zip>S-971 80</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Visby</city>
        <zip>62184</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Örebro</city>
        <zip>701 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>November 1, 2016</last_update_submitted>
  <last_update_submitted_qc>November 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2016</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>
  </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/NCT02199288
org study id: ML29314
nct id: NCT02199288
lead sponsor: 
This prospective, open-label, multicenter, observational study will investigate the
      effectiveness and safety of MabThera SC (rituximab, subcutaneous) induction therapy in
      patients with non-Hodgkin's lymphoma, following a first initial treatment of MabThera IV
      (rituximab, intraveneous). Induction treatment period in the study is estimated to be 8
      months.
observational model: Cohort
time perspective: Prospective
measure: Response rate using the International Working Group criteria
time frame: 8 months
measure: Incidence of adverse events
time frame: Through to end of study, up to approximately 1 year
measure: Incidence of administration related reactions during induction therapy in patients who have previously received at least one dose of MabThera IV
time frame: Through to end of study, up to approximately 1 year
measure: Incidence of serious adverse events
time frame: Through to end of study, up to approximately 1 year
arm group label: 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: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin