<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/NCT03766516</url>
  </required_header>
  <id_info>
    <org_study_id>2018-06-006</org_study_id>
    <nct_id>NCT03766516</nct_id>
  </id_info>
  <brief_title>Registry of BrentuximabVedotinin Patients With R/R Anaplastic Large Cell Lymphoma or Classical HL</brief_title>
  <acronym>BRAVO</acronym>
  <official_title>A Multi-center and Non-interventional Registry of BrentuximabVedotinin Patients With Relapsed or Refractory Anaplastic Large Cell Lymphoma or Classical Hodgkin Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In case of relapsed or refractory ALK-negative ALCL patients, high-dosage chemotherapy/ stem&#xD;
      cell transplantation is a universal salvage option for patients with sensitivity to&#xD;
      anti-cancer treatment and a relatively successful salvage rate can be expected.&#xD;
&#xD;
      Recently, there has been a report of successful stem cell transplantation with full response&#xD;
      to BrentuximabVedotin induced before stem cell transplantation and BrentuximabVedotin's role&#xD;
      as a bridge therapy before stem cell transplantation has also been suggested.&#xD;
&#xD;
      Hodgkin lymphoma is a type of curable blood cancer with unique tissues and clinical&#xD;
      characteristics. Based on the 2008 WHO classification, Hodgkin lymphoma has two types-nodular&#xD;
      lymphocyte predominant type and classical type-and the classical type is further classified&#xD;
      into four types, nodular sclerosis, mixed cellularity, lymphocyte depletion and&#xD;
      lymphocyte-rich type.&#xD;
&#xD;
      Recently, immune checkpoint inhibitor is reported as a very effective treatment for relapsed&#xD;
      Hodgkin lymphoma and more active treatment such as stem cell transplantation is considered&#xD;
      for younger patients.&#xD;
&#xD;
      Treatment with Brentuximabvedotin targeting CD30+ is also very effective for the treatment of&#xD;
      relapsed Hodgkin lymphoma and considered a good option for patients who are not suitable for&#xD;
      stem cell transplantation or aged patients.&#xD;
&#xD;
      It shows consistent response to anti-CD30 antibody treatment in relation to relapsed&#xD;
      anaplastic large cell lymphoma or Hodgkin lymphoma. The effect of Brentuximabvedotin (BV) has&#xD;
      been proven for relapsed or intractable ALCL targeting CD30 as an antibody-chemical adhesive&#xD;
      in the recent phase-2 study.&#xD;
&#xD;
      As Korea currently lacks real-world evidence in relation to BV, this study was conducted to&#xD;
      address BV's effect as salvage therapy for patients with relapsed/refractoryanaplastic large&#xD;
      cell lymphoma or Hodgkin lymphoma. This study identified the clinical results for treatment&#xD;
      patterns and patients using the collected data and derived critical evidence for treatment&#xD;
      decisions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">December 30, 2021</completion_date>
  <primary_completion_date type="Actual">December 30, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Overall response rate</measure>
    <time_frame>3years</time_frame>
    <description>Rate of patients with complete response and partial response based on Lugano classification.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response retention period</measure>
    <time_frame>3years</time_frame>
    <description>From 1st dose date of Brentuximab Vedotin to progression date.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival period</measure>
    <time_frame>3years</time_frame>
    <description>Period from start of salvage therapy with Brentuximab Vedotin to end of study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of time until next treatment</measure>
    <time_frame>3years</time_frame>
    <description>Length of time from start of salvage therapy with Brentuximab Vedotin to next salvage option after progress of disease.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Relapsed or Refractory Anaplastic Large Cell Lymphoma &amp; Hodgkin Lymphoma</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
    <description>Any patient planning to administer BrentuximabVedotin to treat the target disease.&#xD;
Any patient administering BrentuximabVedotin to treat the target disease.&#xD;
Any patient tracing BrentuximabVedotin after treating the target disease.&#xD;
Any patient administering another salvage option for cancer as the target disease has relapsed after terminating treatment using BrentuximabVedotin.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        1. Any patient planning to administer BrentuximabVedotin to treat the target disease;&#xD;
&#xD;
          2. Any patient administering BrentuximabVedotin to treat the target disease;&#xD;
&#xD;
          3. Any patient tracing BrentuximabVedotin after treating the target disease; or&#xD;
&#xD;
          4. Any patient administering another salvage option for cancer as the target disease has&#xD;
             relapsed after terminating treatment using BrentuximabVedotin.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Any patient subject to one of the following at the start of treatment with&#xD;
        BrentuximabVedotin:&#xD;
&#xD;
          1. Any patient planning to administer BrentuximabVedotin to treat the target disease;&#xD;
&#xD;
          2. Any patient administering BrentuximabVedotin to treat the target disease;&#xD;
&#xD;
          3. Any patient tracing BrentuximabVedotin after treating the target disease; or&#xD;
&#xD;
          4. Any patient administering another salvage option for cancer as the target disease has&#xD;
             relapsed after terminating treatment using BrentuximabVedotin.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. If conditions for target diseases are not met.&#xD;
&#xD;
          2. If conditions for target patients are not met.&#xD;
&#xD;
          3. If patients do not give written consent to participate in study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Gangnam-Gu</state>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>February 4, 2022</last_update_submitted>
  <last_update_submitted_qc>February 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Kim, Seok Jin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </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>Hodgkin Disease</mesh_term>
    <mesh_term>Lymphoma, Large-Cell, Anaplastic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03766516
org study id: 2018-06-006
nct id: NCT03766516
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In case of relapsed or refractory ALK-negative ALCL patients, high-dosage chemotherapy/ stem
      cell transplantation is a universal salvage option for patients with sensitivity to
      anti-cancer treatment and a relatively successful salvage rate can be expected.

      Recently, there has been a report of successful stem cell transplantation with full response
      to BrentuximabVedotin induced before stem cell transplantation and BrentuximabVedotin's role
      as a bridge therapy before stem cell transplantation has also been suggested.

      Hodgkin lymphoma is a type of curable blood cancer with unique tissues and clinical
      characteristics. Based on the 2008 WHO classification, Hodgkin lymphoma has two types-nodular
      lymphocyte predominant type and classical type-and the classical type is further classified
      into four types, nodular sclerosis, mixed cellularity, lymphocyte depletion and
      lymphocyte-rich type.

      Recently, immune checkpoint inhibitor is reported as a very effective treatment for relapsed
      Hodgkin lymphoma and more active treatment such as stem cell transplantation is considered
      for younger patients.

      Treatment with Brentuximabvedotin targeting CD30+ is also very effective for the treatment of
      relapsed Hodgkin lymphoma and considered a good option for patients who are not suitable for
      stem cell transplantation or aged patients.

      It shows consistent response to anti-CD30 antibody treatment in relation to relapsed
      anaplastic large cell lymphoma or Hodgkin lymphoma. The effect of Brentuximabvedotin (BV) has
      been proven for relapsed or intractable ALCL targeting CD30 as an antibody-chemical adhesive
      in the recent phase-2 study.

      As Korea currently lacks real-world evidence in relation to BV, this study was conducted to
      address BV's effect as salvage therapy for patients with relapsed/refractoryanaplastic large
      cell lymphoma or Hodgkin lymphoma. This study identified the clinical results for treatment
      patterns and patients using the collected data and derived critical evidence for treatment
      decisions.
observational model: Cohort
time perspective: Other
measure: Overall response rate
time frame: 3years
description: Rate of patients with complete response and partial response based on Lugano classification.
measure: Response retention period
time frame: 3years
description: From 1st dose date of Brentuximab Vedotin to progression date.
measure: Overall survival period
time frame: 3years
description: Period from start of salvage therapy with Brentuximab Vedotin to end of study.
measure: Length of time until next treatment
time frame: 3years
description: Length of time from start of salvage therapy with Brentuximab Vedotin to next salvage option after progress of disease.
arm group label: Cohort
description: Any patient planning to administer BrentuximabVedotin to treat the target disease.
Any patient administering BrentuximabVedotin to treat the target disease.
Any patient tracing BrentuximabVedotin after treating the target disease.
Any patient administering another salvage option for cancer as the target disease has relapsed after terminating treatment using BrentuximabVedotin.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Kim, Seok Jin
investigator title: Principal Investigator
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Hodgkin Disease
mesh term: Lymphoma, Large-Cell, Anaplastic
sharing ipd: No