<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/NCT01716806</url>
  </required_header>
  <id_info>
    <org_study_id>SGN35-015</org_study_id>
    <nct_id>NCT01716806</nct_id>
  </id_info>
  <brief_title>A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)</brief_title>
  <official_title>A Phase 2 Open-label Study of Brentuximab Vedotin in Front-line Therapy of Hodgkin Lymphoma (HL) an dCD30-expressing Peripheral T-cell Lymphoma (PTCL) in Older Patients or Patients With Significant Comorbidities Ineligible for Standard Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seagen Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Seagen Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial will study brentuximab vedotin to find out whether it is an effective treatment&#xD;
      for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study&#xD;
      will be older or will have other conditions that make them unable to have standard&#xD;
      chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with&#xD;
      other drugs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed to evaluate the efficacy and tolerability of brentuximab vedotin as&#xD;
      monotherapy and in combination with other agents as frontline therapy. There are 6 parts of&#xD;
      the study. The population to be studied includes treatment-naïve patients with classical&#xD;
      Hodgkin lymphoma (HL) or treatment-naïve patients with CD30-expressing peripheral T-cell&#xD;
      lymphoma (PTCL).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 31, 2012</start_date>
  <completion_date type="Anticipated">January 31, 2028</completion_date>
  <primary_completion_date type="Actual">April 7, 2023</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective response rate (ORR) according to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C)</measure>
    <time_frame>Through 1 month following last dose; up to approximately 16 months</time_frame>
    <description>Defined as the proportion of patients with complete response (CR) or (PR)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ORR according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas (Lugano criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D)</measure>
    <time_frame>Through 1 month following last dose; up to approximately 16 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>ORR according to modified Lugano criteria per blinded independent central review (BICR) (Parts E and F)</measure>
    <time_frame>Through 1 month following last dose; up to approximately 16 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only); up to approximately 18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of laboratory abnormalities</measure>
    <time_frame>Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only); up to approximately 18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete remission (CR) rate</measure>
    <time_frame>Through 1 month following last dose; up to approximately 16 months</time_frame>
    <description>Defined as the proportion of patients with CR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of complete response</measure>
    <time_frame>Up to approximately 10 years</time_frame>
    <description>Defined as the time from start of the first documentation of complete tumor response (CR) to the first documentation of tumor progression or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of objective response</measure>
    <time_frame>Up to approximately 10 years</time_frame>
    <description>Defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>Up to approximately 10 years</time_frame>
    <description>Defined as the time from start of study treatment to first documentation of tumor progression or death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate</measure>
    <time_frame>Up to approximately 10 years</time_frame>
    <description>Defined as the proportion of patients with CR, PR, or stable disease (SD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR according to Lugano criteria per BICR (Parts E and F)</measure>
    <time_frame>Through 1 month following last dose; up to approximately 16 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>B symptom resolution rate</measure>
    <time_frame>Through 1 month following last dose; up to approximately 16 months</time_frame>
    <description>Defined as the proportion of patients with lymphoma-related B symptoms at baseline who achieve resolution of all B symptoms at any time during the treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood concentrations of brentuximab vedotin</measure>
    <time_frame>Up to approximately 16 months. Cycle 1: predose, 30 minutes, and 24, 48, 168, and 336 hours post-dose; Cycles 2 and later (through 1 month post last dose): pre-dose and 30 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of brentuximab vedotin antitherapeutic antibodies (ATA)</measure>
    <time_frame>Up to approximately 18 months. Cycles 1, 2, 4, and every 4 cycles thereafter (through 1 month post last dose [Parts A, B, and C] or through 100 days post last dose of nivolumab [Part D only]): predose</time_frame>
    <description>Defined as the proportion of patients who develop ATA to brentuximab vedotin at any time during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood concentrations of nivolumab (Part D only)</measure>
    <time_frame>Up to approximately 16 months. Cycle 1: predose, 30 minutes, and 168 and 336 hours post-dose; Cycles 2, 4, and every 4 cycles thereafter (through 1 month post last dose): pre-dose and 30 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of nivolumab antitherapeutic antibodies (ATA) (Part D only)</measure>
    <time_frame>Up to approximately 18 months. Cycles 1, 2, 4, and every 4 cycles thereafter (through 100 days post last dose of nivolumab): predose</time_frame>
    <description>Defined as the proportion of patients who develop ATA to nivolumab at any time during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (Parts E and F only)</measure>
    <time_frame>Up to approximately 5 years</time_frame>
    <description>Defined as the time from start of study treatment to date of death due to any cause</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">131</enrollment>
  <condition>Hodgkin Disease</condition>
  <condition>Peripheral T Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>Part A: Brentuximab Vedotin in HL Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: Brentuximab Vedotin + Dacarbazine in HL Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C: Brentuximab Vedotin + Bendamustine in HL Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part D: Brentuximab Vedotin + Nivolumab in HL Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part E: Brentuximab Vedotin in HL Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part F: Brentuximab Vedotin in PTCL Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>brentuximab vedotin</intervention_name>
    <description>1.8 mg/kg every 3 weeks by IV infusion</description>
    <arm_group_label>Part A: Brentuximab Vedotin in HL Patients</arm_group_label>
    <arm_group_label>Part B: Brentuximab Vedotin + Dacarbazine in HL Patients</arm_group_label>
    <arm_group_label>Part C: Brentuximab Vedotin + Bendamustine in HL Patients</arm_group_label>
    <arm_group_label>Part D: Brentuximab Vedotin + Nivolumab in HL Patients</arm_group_label>
    <arm_group_label>Part E: Brentuximab Vedotin in HL Patients</arm_group_label>
    <arm_group_label>Part F: Brentuximab Vedotin in PTCL Patients</arm_group_label>
    <other_name>Adcetris; SGN-35</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bendamustine</intervention_name>
    <description>70 mg/m^2 by IV infusion on Days 1 and 2 of 3-week cycle</description>
    <arm_group_label>Part C: Brentuximab Vedotin + Bendamustine in HL Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dacarbazine</intervention_name>
    <description>375 mg/m^2 every 3 weeks by IV infusion</description>
    <arm_group_label>Part B: Brentuximab Vedotin + Dacarbazine in HL Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>nivolumab</intervention_name>
    <description>3 mg/kg every 3 weeks by IV infusion</description>
    <arm_group_label>Part D: Brentuximab Vedotin + Nivolumab in HL Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parts A, B, C, and D: 60 years of age or older&#xD;
&#xD;
          -  Treatment-naive patients with histopathological diagnosis of classical Hodgkin&#xD;
             lymphoma (Parts A, B, C, D, and E)&#xD;
&#xD;
          -  Treatment-naive patients with CD30-expressing PTCL (Part F)&#xD;
&#xD;
          -  Ineligible for or have declined initial conventional combination chemotherapy for HL&#xD;
             (Parts A, B, C, and D)&#xD;
&#xD;
          -  Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E)&#xD;
             or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by:&#xD;
&#xD;
               -  A CIRS score of 10 or greater&#xD;
&#xD;
               -  Requiring assistance with or dependence on other for any instrumental activities&#xD;
                  of daily living (IADLs)&#xD;
&#xD;
          -  Measurable disease of at least 1.5 cm as documented by radiographic technique&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3&#xD;
             (Parts, A, B, C, E, and F) or less than or equal to 2 (Part D)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Symptomatic neurologic disease compromising IADLs or requiring medication&#xD;
&#xD;
          -  History of progressive multifocal leukoencephalopathy&#xD;
&#xD;
          -  Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the&#xD;
             first dose of brentuximab vedotin&#xD;
&#xD;
          -  Concurrent use of other investigational agents&#xD;
&#xD;
          -  Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not&#xD;
             completed 4 weeks prior to first dose of study drug&#xD;
&#xD;
          -  History of another malignancy within 1 year before first dose of study drug (Parts E&#xD;
             and F only)&#xD;
&#xD;
          -  Part D only:&#xD;
&#xD;
               -  Received any prior immune-oncology therapy&#xD;
&#xD;
               -  History of known or suspected autoimmune disease&#xD;
&#xD;
               -  Prior allogeneic stem cell transplant&#xD;
&#xD;
               -  History of cerebral vascular event within 6 months of first dose of study drug&#xD;
&#xD;
               -  Active interstitial lung disease that is symptomatic or may interfere with the&#xD;
                  detection or management of suspected drug-related pulmonary toxicology&#xD;
&#xD;
               -  Known history of pancreatitis&#xD;
&#xD;
          -  Parts D, E, and F only:&#xD;
&#xD;
               -  Known cerebral/meningeal disease related to the underlying malignancy&#xD;
&#xD;
               -  Systemic treatment with corticosteroids or other immunosuppressive medications&#xD;
                  within 1 week of enrollment&#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>Robert Sims, MD</last_name>
    <role>Study Director</role>
    <affiliation>Seagen Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Alabama - Mitchell Cancer Institute</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alaska Urological Institute</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Banner MD Anderson Cancer Center</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Oncology Associates, PC - HOPE</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Cancer Center / University of Arizona</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724-5024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Highlands Oncology Group</name>
      <address>
        <city>Springdale</city>
        <state>Arkansas</state>
        <zip>J. Thaddeus Beck</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence St Joseph Medical Center</name>
      <address>
        <city>Burbank</city>
        <state>California</state>
        <zip>91505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope National Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilshire Oncology Medical Group Inc.</name>
      <address>
        <city>Pomona</city>
        <state>California</state>
        <zip>91767</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers - Aurora</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Affiliates</name>
      <address>
        <city>Trinity</city>
        <state>Florida</state>
        <zip>34655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IACT Health</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Cancer Specialists / Northside Hospital Cancer Institute</name>
      <address>
        <city>Sandy Springs</city>
        <state>Georgia</state>
        <zip>30341</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Cancer Specialists / Advocate Lutheran General Hospital</name>
      <address>
        <city>Niles</city>
        <state>Illinois</state>
        <zip>60714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Oncology Networks LLC</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Institute / Wayne State University</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology Hematology P.A.</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Cancer Specialists</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morristown Medical Center/ Carol G. Simon Cancer Center</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers Cancer Institute of New Jersey</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Oncology Hematology, P.C.</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James P. Wilmot Cancer Center / University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Hematology Care</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James Cancer Hospital / Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Willamette Valley Cancer Institute and Research Center</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Cancer Specialists, P.C.</name>
      <address>
        <city>Tigard</city>
        <state>Oregon</state>
        <zip>97223</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prisma Health</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arlington Cancer Center</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Bedford</name>
      <address>
        <city>Bedford</city>
        <state>Texas</state>
        <zip>76022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Presbyterian Cancer Center Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Denton South</name>
      <address>
        <city>Denton</city>
        <state>Texas</state>
        <zip>Kurkul</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Fort Worth 12th Avenue</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center / University of Texas</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Longview</name>
      <address>
        <city>Longview</city>
        <state>Texas</state>
        <zip>75601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - McAllen</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Seton Williamson</name>
      <address>
        <city>Round Rock</city>
        <state>Texas</state>
        <zip>78665</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists, PC</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University Medical Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care</name>
      <address>
        <city>Salem</city>
        <state>Virginia</state>
        <zip>24153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shenandoah Oncology P.C.</name>
      <address>
        <city>Winchester</city>
        <state>Virginia</state>
        <zip>22601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benaroya Research Institute/Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Cancer Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wenatchee Valley Medical Center</name>
      <address>
        <city>Wenatchee</city>
        <state>Washington</state>
        <zip>98821</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carbone Cancer Center / University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alberta / Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Centre - Victoria Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIUSSS de L'Est de l'lle de Montreal / installation Hopital Maisonneuve-Rosemont</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Victoria Hospital, McGill University Health Centre</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Antibody-Drug Conjugate</keyword>
  <keyword>Antibodies, Monoclonal</keyword>
  <keyword>Hematologic Diseases</keyword>
  <keyword>Hodgkin Disease</keyword>
  <keyword>Antigens, CD30</keyword>
  <keyword>Lymphoma</keyword>
  <keyword>monomethylauristatin E</keyword>
  <keyword>Drug Therapy</keyword>
  <keyword>CD30-expression</keyword>
  <keyword>PTCL</keyword>
  <keyword>Seattle Genetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Hodgkin Disease</mesh_term>
    <mesh_term>Lymphoma, T-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Peripheral</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nivolumab</mesh_term>
    <mesh_term>Brentuximab Vedotin</mesh_term>
    <mesh_term>Bendamustine Hydrochloride</mesh_term>
    <mesh_term>Dacarbazine</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/NCT01716806
org study id: SGN35-015
nct id: NCT01716806
lead sponsor: 
collaborator: 
has dmc: No
This trial will study brentuximab vedotin to find out whether it is an effective treatment
      for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study
      will be older or will have other conditions that make them unable to have standard
      chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with
      other drugs.
This study is designed to evaluate the efficacy and tolerability of brentuximab vedotin as
      monotherapy and in combination with other agents as frontline therapy. There are 6 parts of
      the study. The population to be studied includes treatment-naïve patients with classical
      Hodgkin lymphoma (HL) or treatment-naïve patients with CD30-expressing peripheral T-cell
      lymphoma (PTCL).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate (ORR) according to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C)
time frame: Through 1 month following last dose; up to approximately 16 months
description: Defined as the proportion of patients with complete response (CR) or (PR)
measure: ORR according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas (Lugano criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D)
time frame: Through 1 month following last dose; up to approximately 16 months
measure: ORR according to modified Lugano criteria per blinded independent central review (BICR) (Parts E and F)
time frame: Through 1 month following last dose; up to approximately 16 months
measure: Incidence of adverse events
time frame: Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only); up to approximately 18 months
measure: Incidence of laboratory abnormalities
time frame: Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only); up to approximately 18 months
measure: Complete remission (CR) rate
time frame: Through 1 month following last dose; up to approximately 16 months
description: Defined as the proportion of patients with CR
measure: Duration of complete response
time frame: Up to approximately 10 years
description: Defined as the time from start of the first documentation of complete tumor response (CR) to the first documentation of tumor progression or death
measure: Duration of objective response
time frame: Up to approximately 10 years
description: Defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or death
measure: Progression-free survival
time frame: Up to approximately 10 years
description: Defined as the time from start of study treatment to first documentation of tumor progression or death due to any cause
measure: Disease control rate
time frame: Up to approximately 10 years
description: Defined as the proportion of patients with CR, PR, or stable disease (SD)
measure: ORR according to Lugano criteria per BICR (Parts E and F)
time frame: Through 1 month following last dose; up to approximately 16 months
measure: B symptom resolution rate
time frame: Through 1 month following last dose; up to approximately 16 months
description: Defined as the proportion of patients with lymphoma-related B symptoms at baseline who achieve resolution of all B symptoms at any time during the treatment period
measure: Blood concentrations of brentuximab vedotin
time frame: Up to approximately 16 months. Cycle 1: predose, 30 minutes, and 24, 48, 168, and 336 hours post-dose; Cycles 2 and later (through 1 month post last dose): pre-dose and 30 minutes
measure: Incidence of brentuximab vedotin antitherapeutic antibodies (ATA)
time frame: Up to approximately 18 months. Cycles 1, 2, 4, and every 4 cycles thereafter (through 1 month post last dose [Parts A, B, and C] or through 100 days post last dose of nivolumab [Part D only]): predose
description: Defined as the proportion of patients who develop ATA to brentuximab vedotin at any time during the study
measure: Blood concentrations of nivolumab (Part D only)
time frame: Up to approximately 16 months. Cycle 1: predose, 30 minutes, and 168 and 336 hours post-dose; Cycles 2, 4, and every 4 cycles thereafter (through 1 month post last dose): pre-dose and 30 minutes
measure: Incidence of nivolumab antitherapeutic antibodies (ATA) (Part D only)
time frame: Up to approximately 18 months. Cycles 1, 2, 4, and every 4 cycles thereafter (through 100 days post last dose of nivolumab): predose
description: Defined as the proportion of patients who develop ATA to nivolumab at any time during the study
measure: Overall survival (Parts E and F only)
time frame: Up to approximately 5 years
description: Defined as the time from start of study treatment to date of death due to any cause
arm group label: Part A: Brentuximab Vedotin in HL Patients
arm group type: Experimental
arm group label: Part B: Brentuximab Vedotin + Dacarbazine in HL Patients
arm group type: Experimental
arm group label: Part C: Brentuximab Vedotin + Bendamustine in HL Patients
arm group type: Experimental
arm group label: Part D: Brentuximab Vedotin + Nivolumab in HL Patients
arm group type: Experimental
arm group label: Part E: Brentuximab Vedotin in HL Patients
arm group type: Experimental
arm group label: Part F: Brentuximab Vedotin in PTCL Patients
arm group type: Experimental
intervention type: Drug
intervention name: brentuximab vedotin
description: 1.8 mg/kg every 3 weeks by IV infusion
arm group label: Part A: Brentuximab Vedotin in HL Patients
arm group label: Part B: Brentuximab Vedotin + Dacarbazine in HL Patients
arm group label: Part C: Brentuximab Vedotin + Bendamustine in HL Patients
arm group label: Part D: Brentuximab Vedotin + Nivolumab in HL Patients
arm group label: Part E: Brentuximab Vedotin in HL Patients
arm group label: Part F: Brentuximab Vedotin in PTCL Patients
other name: Adcetris; SGN-35
intervention type: Drug
intervention name: bendamustine
description: 70 mg/m^2 by IV infusion on Days 1 and 2 of 3-week cycle
arm group label: Part C: Brentuximab Vedotin + Bendamustine in HL Patients
intervention type: Drug
intervention name: dacarbazine
description: 375 mg/m^2 every 3 weeks by IV infusion
arm group label: Part B: Brentuximab Vedotin + Dacarbazine in HL Patients
intervention type: Drug
intervention name: nivolumab
description: 3 mg/kg every 3 weeks by IV infusion
arm group label: Part D: Brentuximab Vedotin + Nivolumab in HL Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Sims, MD
role: Study Director
affiliation: Seagen Inc.
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Hodgkin Disease
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral
mesh term: Nivolumab
mesh term: Brentuximab Vedotin
mesh term: Bendamustine Hydrochloride
mesh term: Dacarbazine