<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/NCT03235869</url>
  </required_header>
  <id_info>
    <org_study_id>UMCC 2017.079</org_study_id>
    <secondary_id>HUM00131550</secondary_id>
    <nct_id>NCT03235869</nct_id>
  </id_info>
  <brief_title>Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma</brief_title>
  <official_title>A Single Arm Pilot Study of Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan Rogel Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan Rogel Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single arm, single stage pilot study of radiation therapy plus durvalumab for&#xD;
      tumor-stage cutaneous T-cell lymphoma (CTCL).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The company pulled durvalumab from heme malignancies&#xD;
  </why_stopped>
  <start_date type="Anticipated">March 1, 2018</start_date>
  <completion_date type="Anticipated">March 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2023</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of patients that respond to treatment</measure>
    <time_frame>1 year post treatment</time_frame>
    <description>Overall Response Rate (ORR) is defined as the percentage of patients that obtain a Complete Response (CR) or Partial Response (PR) to treatment. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The percentage of patients that completely respond to treatment</measure>
    <time_frame>1 year post treatment</time_frame>
    <description>Complete Response Rate (CRR) is defined as the percentage of patients that obtain Complete Response (CR) to treatment. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to response</measure>
    <time_frame>1 year post treatment</time_frame>
    <description>The time to response is measured from the start of the treatment until criteria are met for CR or PR. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of overall response</measure>
    <time_frame>1 year post treatment</time_frame>
    <description>The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrence or PD (Progressive disease) is objectively documented. A global composite scoring system will be used to determine response and progression. Skin, nodes, viscera and blood will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival time</measure>
    <time_frame>1 year post treatment</time_frame>
    <description>Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death. A global composite scoring system will be used to determine progression. Skin, nodes, viscera and blood will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to next treatment</measure>
    <time_frame>1 year post treatment</time_frame>
    <description>Time to next treatment is defined as the duration of time from start of study treatment to next treatment or death of any cause, whichever comes first.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Cutaneous T Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>Radiation Therapy + Durvalumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Radiation to 1-3 cutaneous tumors: 20 Gy (4 Gy x 5 fractions) Durvalumab 1500mg IV over 1 hour administered within 2-7 days of initiation of radiation, then every 28 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Durvalumab</intervention_name>
    <description>Durvalumab 1500mg IV over 1 hour administered within 2-7 days of initiation of radiation, then every 28 days.</description>
    <arm_group_label>Radiation Therapy + Durvalumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation Therapy</intervention_name>
    <description>Radiation to 1-3 cutaneous tumors: 20 Gy (4 Gy x 5 fractions)</description>
    <arm_group_label>Radiation Therapy + Durvalumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Voluntarily provide written IRB-approved consent&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Histologically proven CTCL&#xD;
&#xD;
          -  Stage IIB-IV CTCL with ≥2 cutaneous tumors assessable for response&#xD;
&#xD;
          -  At least one cutaneous tumor amenable to radiation therapy. Must have at least 1 tumor&#xD;
             assessable for response that will not undergo radiation.&#xD;
&#xD;
          -  Adequate organ function&#xD;
&#xD;
          -  Prior treatment is allowed if at least 4 weeks have elapsed since last chemotherapy&#xD;
             and/or radiation and the subject has recovered from all treatment related toxicity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior allogeneic stem cell transplant.&#xD;
&#xD;
          -  Prior treatment with a PD-1/PD-L1 inhibitor&#xD;
&#xD;
          -  Active or prior documented autoimmune or inflammatory disorders within the past 3&#xD;
             years prior to the start of treatment.&#xD;
&#xD;
          -  Current or prior use of immunosuppressive medication within 14 days prior to first&#xD;
             dose of durvalumab.&#xD;
&#xD;
          -  Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or active hepatitis&#xD;
             B virus (HBV) infection.&#xD;
&#xD;
          -  History of hypersensitivity to durvalumab or any excipient&#xD;
&#xD;
          -  Receipt of live attenuated vaccination within 30 days prior the first dose of&#xD;
             durvalumab.&#xD;
&#xD;
          -  Female subjects who are pregnant, breast-feeding or female patients of reproductive&#xD;
             potential who are not employing an effective method of birth control&#xD;
&#xD;
          -  Male subjects who are not employing an effective method of birth control&#xD;
&#xD;
          -  Uncontrolled current medical illness, including, but not limited to ongoing or active&#xD;
             infections, symptomatic congestive heart failure, unstable angina pectoris,unstable&#xD;
             cardiac arrhythmia and/or psychiatric illness or other condition that in the opinion&#xD;
             of the investigator would limit compliance with study requirements.&#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>&quot;Ryan Wilcox, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan Rogel Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan Comprehensive Cancer Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>March 13, 2018</last_update_submitted>
  <last_update_submitted_qc>March 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2018</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, T-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Peripheral</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Cutaneous</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Durvalumab</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/NCT03235869
org study id: UMCC 2017.079
secondary id: HUM00131550
nct id: NCT03235869
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a single arm, single stage pilot study of radiation therapy plus durvalumab for
      tumor-stage cutaneous T-cell lymphoma (CTCL).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The percentage of patients that respond to treatment
time frame: 1 year post treatment
description: Overall Response Rate (ORR) is defined as the percentage of patients that obtain a Complete Response (CR) or Partial Response (PR) to treatment. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.
measure: The percentage of patients that completely respond to treatment
time frame: 1 year post treatment
description: Complete Response Rate (CRR) is defined as the percentage of patients that obtain Complete Response (CR) to treatment. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.
measure: Time to response
time frame: 1 year post treatment
description: The time to response is measured from the start of the treatment until criteria are met for CR or PR. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.
measure: Duration of overall response
time frame: 1 year post treatment
description: The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrence or PD (Progressive disease) is objectively documented. A global composite scoring system will be used to determine response and progression. Skin, nodes, viscera and blood will be assessed.
measure: Progression free survival time
time frame: 1 year post treatment
description: Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death. A global composite scoring system will be used to determine progression. Skin, nodes, viscera and blood will be assessed.
measure: Time to next treatment
time frame: 1 year post treatment
description: Time to next treatment is defined as the duration of time from start of study treatment to next treatment or death of any cause, whichever comes first.
arm group label: Radiation Therapy + Durvalumab
arm group type: Experimental
description: Radiation to 1-3 cutaneous tumors: 20 Gy (4 Gy x 5 fractions) Durvalumab 1500mg IV over 1 hour administered within 2-7 days of initiation of radiation, then every 28 days.
intervention type: Drug
intervention name: Durvalumab
description: Durvalumab 1500mg IV over 1 hour administered within 2-7 days of initiation of radiation, then every 28 days.
arm group label: Radiation Therapy + Durvalumab
intervention type: Radiation
intervention name: Radiation Therapy
description: Radiation to 1-3 cutaneous tumors: 20 Gy (4 Gy x 5 fractions)
arm group label: Radiation Therapy + Durvalumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: "Ryan Wilcox, M.D., Ph.D.
role: Principal Investigator
affiliation: University of Michigan Rogel Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral
mesh term: Lymphoma, T-Cell, Cutaneous
mesh term: Durvalumab