<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/NCT01724294</url>
  </required_header>
  <id_info>
    <org_study_id>ML28497</org_study_id>
    <nct_id>NCT01724294</nct_id>
  </id_info>
  <brief_title>An Observational Study of MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in First-Line in Patients With Diffuse Large B-Cell Lymphoma</brief_title>
  <official_title>Non-interventional, Post-marketing Study to Evaluate the Correlation Between Clinical and Biological Factors and IPI as Prognostic Factors in Patients With DLBCL in First Line Treatment With R-CHOP</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 multicenter, observational study will evaluate the correlation between clinical and&#xD;
      biological factors and International Prognostic Index (IPI) as prognostic factors in patients&#xD;
      with diffuse large B-cell lymphoma receiving first-line treatment with MabThera/Rituxan&#xD;
      (rituximab) in combination with CHOP chemotherapy. Eligible patients receiving treatment&#xD;
      according to standard of care and local guidelines will be followed for the duration of&#xD;
      treatment (approximately 8 months) and during 1 year of follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 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>Treatment patterns in clinical practice: Number of treatment cycles received</measure>
    <time_frame>approximately 4 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Event-free survival</measure>
    <time_frame>approximately 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rates</measure>
    <time_frame>approximately 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Incidence of adverse events</measure>
    <time_frame>approximately 4 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">113</enrollment>
  <condition>Diffuse Large B-Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with diffuse large B-cell lymphoma treated in first line with R-CHOP&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, &gt;18 years of age&#xD;
&#xD;
          -  Patients with diagnosed diffuse large B-cell lymphoma in first-line treatment with&#xD;
             R-CHOP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior chemotherapy treatment for diffuse large B-cell lymphoma&#xD;
&#xD;
          -  Contra-indications or exclusion criteria according to the Summary of Product&#xD;
             Characteristics for MabThera/Rituxan&#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>Bucuresti</city>
        <zip>030171</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</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, B-Cell</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</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/NCT01724294
org study id: ML28497
nct id: NCT01724294
lead sponsor: 
This multicenter, observational study will evaluate the correlation between clinical and
      biological factors and International Prognostic Index (IPI) as prognostic factors in patients
      with diffuse large B-cell lymphoma receiving first-line treatment with MabThera/Rituxan
      (rituximab) in combination with CHOP chemotherapy. Eligible patients receiving treatment
      according to standard of care and local guidelines will be followed for the duration of
      treatment (approximately 8 months) and during 1 year of follow-up.
observational model: Cohort
time perspective: Prospective
measure: Treatment patterns in clinical practice: Number of treatment cycles received
time frame: approximately 4 years
measure: Event-free survival
time frame: approximately 4 years
measure: Response rates
time frame: approximately 4 years
measure: Safety: Incidence of adverse events
time frame: approximately 4 years
arm group label: Cohort
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: Romania
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse