<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/NCT02191930</url>
  </required_header>
  <id_info>
    <org_study_id>B-CAP</org_study_id>
    <nct_id>NCT02191930</nct_id>
  </id_info>
  <brief_title>Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma</brief_title>
  <acronym>B-CAP</acronym>
  <official_title>Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma - a GHSG-NLG Intergroup Phase II Trial -</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cologne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Cologne</source>
  <brief_summary>
    <textblock>
      The purpose of this trial is to determine&#xD;
&#xD;
        1. Objective response rate (ORR), defined as the proportion of patients having CR, CRr or&#xD;
           PR in the centrally reviewed restaging after six cycles of chemotherapy&#xD;
&#xD;
        2. Progression-free survival (PFS) 3 years after registration&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Actual">March 2022</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>after 6 cycles of therapy (at least 18 weeks after start of treatment)</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Hodgkin Lymphoma</condition>
  <arm_group>
    <arm_group_label>B-CAP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with ECOG of 2 or less (3 or less if caused by HL) and CIRS-G score of 6 or less (overall) and 3 or less per organ system receive 6 cycles of B-CAP (Brentuximab vedotin, cyclophosphamide, doxorubicine, predniso(lo)ne). Cycle length is 21 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brentoximab Vedotin only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with CIRS-G score of 7 ore more receive Brentuximab Vedotin as single agent therapy for up to 16 cycles. Cycle length is 21 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>B-CAP</intervention_name>
    <arm_group_label>B-CAP</arm_group_label>
    <other_name>Brentuximab Vedotin</other_name>
    <other_name>Cyclophosphamide</other_name>
    <other_name>Doxorubicine</other_name>
    <other_name>Predniso(lo)ne</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Brentuximab Vedotin</intervention_name>
    <arm_group_label>Brentoximab Vedotin only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (B-CAP):&#xD;
&#xD;
          -  classical Hodgkin Lymphoma&#xD;
&#xD;
          -  Age 60 years or older&#xD;
&#xD;
          -  ECOG performance status ≤ 2 or ≤ 3 if due to HL&#xD;
&#xD;
          -  CIRS-G score of ≤ 6 and ≤ 3 per organ system (except score 4 for eye, ear, nose and&#xD;
             throat)&#xD;
&#xD;
          -  Advanced stages: Stage IIB with large mediastinal mass and/or extranodal lesions,&#xD;
             stage III or IV disease&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria (B-CAP):&#xD;
&#xD;
          -  Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)&#xD;
&#xD;
          -  Prior chemotherapy or radiation for HL except prephase&#xD;
&#xD;
          -  Peripheral neuropathy greater than CTC Grade 1&#xD;
&#xD;
        Inclusion Criteria (BV only):&#xD;
&#xD;
          -  classical Hodgkin Lymphoma&#xD;
&#xD;
          -  Age 60 years or older&#xD;
&#xD;
          -  stage IA to IVB&#xD;
&#xD;
          -  CIRS-G score of ≥ 7 or 4 in one organ system (except score 4 for eye, ear, nose and&#xD;
             throat)&#xD;
&#xD;
          -  Patients not eligible to curative poly-chemotherapy at the investigators judgment&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria (BV only):&#xD;
&#xD;
          -  Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)&#xD;
&#xD;
          -  Prior chemotherapy or radiation for HL except prephase as outlined in the protocol&#xD;
&#xD;
          -  Peripheral neuropathy greater than CTC Grade 1&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Borchmann, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Cologne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>1st Dept. of Medicine, Cologne University Hospital</name>
      <address>
        <city>Cologne</city>
        <zip>50924</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.ghsg.org</url>
    <description>Homepage GHSG</description>
  </link>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>August 5, 2022</last_update_submitted>
  <last_update_submitted_qc>August 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cologne</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Peter Borchmann</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Hodgkin Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Doxorubicin</mesh_term>
    <mesh_term>Brentuximab Vedotin</mesh_term>
    <mesh_term>Antibodies, Monoclonal</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/NCT02191930
org study id: B-CAP
nct id: NCT02191930
lead sponsor: 
The purpose of this trial is to determine

        1. Objective response rate (ORR), defined as the proportion of patients having CR, CRr or
           PR in the centrally reviewed restaging after six cycles of chemotherapy

        2. Progression-free survival (PFS) 3 years after registration
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate
time frame: after 6 cycles of therapy (at least 18 weeks after start of treatment)
arm group label: B-CAP
arm group type: Experimental
description: Patients with ECOG of 2 or less (3 or less if caused by HL) and CIRS-G score of 6 or less (overall) and 3 or less per organ system receive 6 cycles of B-CAP (Brentuximab vedotin, cyclophosphamide, doxorubicine, predniso(lo)ne). Cycle length is 21 days
arm group label: Brentoximab Vedotin only
arm group type: Experimental
description: Patients with CIRS-G score of 7 ore more receive Brentuximab Vedotin as single agent therapy for up to 16 cycles. Cycle length is 21 days
intervention type: Drug
intervention name: B-CAP
arm group label: B-CAP
other name: Brentuximab Vedotin
other name: Cyclophosphamide
other name: Doxorubicine
other name: Predniso(lo)ne
intervention type: Drug
intervention name: Brentuximab Vedotin
arm group label: Brentoximab Vedotin only
criteria: 
gender: All
minimum age: 60 Years
maximum age: 99 Years
healthy volunteers: No
last name: Peter Borchmann, Prof.
role: Principal Investigator
affiliation: University Hospital of Cologne
facility: 
country: Germany
url: http://www.ghsg.org
description: Homepage GHSG
responsible party type: Principal Investigator
investigator affiliation: University of Cologne
investigator full name: Prof. Dr. Peter Borchmann
investigator title: Prof.
mesh term: Lymphoma
mesh term: Hodgkin Disease
mesh term: Cyclophosphamide
mesh term: Doxorubicin
mesh term: Brentuximab Vedotin
mesh term: Antibodies, Monoclonal