<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/NCT03004833</url>
  </required_header>
  <id_info>
    <org_study_id>Uni-Koeln-2854</org_study_id>
    <nct_id>NCT03004833</nct_id>
  </id_info>
  <brief_title>Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma</brief_title>
  <acronym>NIVAHL</acronym>
  <official_title>Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cologne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Cologne</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of the trial is to improve first-line treatment for early unfavorable cHL by&#xD;
      introduction of the anti-PD-1 antibody Nivolumab with a truncated standard chemotherapy&#xD;
      (AVD).&#xD;
&#xD;
      The primary objective is to show efficacy of the two experimental treatment strategies.&#xD;
      Secondary objectives are to further evaluate efficacy, show safety and feasibility and&#xD;
      perform correlative studies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 21, 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete Remission Rate</measure>
    <time_frame>4 to 6 weeks after end of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment related Morbidity</measure>
    <time_frame>1 year after end of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>1 and 3 years after end of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>1 and 3 years after end of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Classical Hodgkin Lymphoma</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 Cycles of Nivolumab, followed by 2 cycles of Nivolumab plus AVD, followed by 2 Cycles of AVD followed by IF-RT (30 Gy)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Infusion of Nivolumab</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adriamycin</intervention_name>
    <description>Infusion of Adriamycin</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vinblastine</intervention_name>
    <description>Infusion of Vinblastine</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dacarbazine</intervention_name>
    <description>Infusion of Dacarbazine</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven classical HL&#xD;
&#xD;
          -  First diagnosis, no previous treatment&#xD;
&#xD;
          -  Age: 18-60 years&#xD;
&#xD;
          -  Stage I, IIA with risk factors a-d, IIB with RF c-d:&#xD;
&#xD;
               1. large mediastinal mass&#xD;
&#xD;
               2. extranodal lesions&#xD;
&#xD;
               3. elevated ESR&#xD;
&#xD;
               4. ≥ 3 nodal areas confirmed by central review.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)&#xD;
&#xD;
          -  History of other malignancy ≤ 5 years&#xD;
&#xD;
          -  Prior chemotherapy or radiation therapy&#xD;
&#xD;
          -  Concurrent disease precluding protocol treatment&#xD;
&#xD;
          -  Pregnancy, lactation&#xD;
&#xD;
          -  Non-compliance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Engert, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cologne, I. Dept. of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Cologne</name>
      <address>
        <city>Cologne</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.ghsg.org</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</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. Andreas Engert</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>Nivolumab</mesh_term>
    <mesh_term>Doxorubicin</mesh_term>
    <mesh_term>Liposomal doxorubicin</mesh_term>
    <mesh_term>Dacarbazine</mesh_term>
    <mesh_term>Vinblastine</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/NCT03004833
org study id: Uni-Koeln-2854
nct id: NCT03004833
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the trial is to improve first-line treatment for early unfavorable cHL by
      introduction of the anti-PD-1 antibody Nivolumab with a truncated standard chemotherapy
      (AVD).

      The primary objective is to show efficacy of the two experimental treatment strategies.
      Secondary objectives are to further evaluate efficacy, show safety and feasibility and
      perform correlative studies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complete Remission Rate
time frame: 4 to 6 weeks after end of treatment
measure: Treatment related Morbidity
time frame: 1 year after end of treatment
measure: Progression Free Survival
time frame: 1 and 3 years after end of treatment
measure: Overall Survival
time frame: 1 and 3 years after end of treatment
arm group label: Arm A
arm group type: Experimental
description: 4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy)
arm group label: Arm B
arm group type: Experimental
description: 4 Cycles of Nivolumab, followed by 2 cycles of Nivolumab plus AVD, followed by 2 Cycles of AVD followed by IF-RT (30 Gy)
intervention type: Drug
intervention name: Nivolumab
description: Infusion of Nivolumab
arm group label: Arm A
arm group label: Arm B
intervention type: Drug
intervention name: Adriamycin
description: Infusion of Adriamycin
arm group label: Arm A
arm group label: Arm B
intervention type: Drug
intervention name: Vinblastine
description: Infusion of Vinblastine
arm group label: Arm A
arm group label: Arm B
intervention type: Drug
intervention name: Dacarbazine
description: Infusion of Dacarbazine
arm group label: Arm A
arm group label: Arm B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Andreas Engert, Prof.
role: Principal Investigator
affiliation: University of Cologne, I. Dept. of Medicine
facility: 
country: Germany
url: http://www.ghsg.org
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: University of Cologne
investigator full name: Prof. Dr. Andreas Engert
investigator title: Prof.
mesh term: Lymphoma
mesh term: Hodgkin Disease
mesh term: Nivolumab
mesh term: Doxorubicin
mesh term: Liposomal doxorubicin
mesh term: Dacarbazine
mesh term: Vinblastine