<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/NCT02203578</url>
  </required_header>
  <id_info>
    <org_study_id>021309</org_study_id>
    <secondary_id>NCI-2014-01411</secondary_id>
    <secondary_id>021309</secondary_id>
    <secondary_id>P30CA072720</secondary_id>
    <secondary_id>Pro2014004116</secondary_id>
    <nct_id>NCT02203578</nct_id>
  </id_info>
  <brief_title>Romidepsin in Treating Patients With Steroid-Refractory Graft-versus-Host Disease</brief_title>
  <official_title>A Pilot Study of Romidepsin for Therapy of Graft-versus-Host Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rutgers, The State University of New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rutgers Cancer Institute of New Jersey</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rutgers, The State University of New Jersey</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies romidepsin in treating patients with graft-versus-host&#xD;
      disease (GVHD) that has not responded to treatment with steroids. Romidepsin may be an&#xD;
      effective treatment for graft-versus-host disease caused by a bone marrow or stem cell&#xD;
      transplant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine if romidepsin should be developed as a therapy for patients with&#xD;
      steroid-refractory GVHD.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive romidepsin intravenously (IV) over 4 hours on days 1, 8, and 15. Treatment&#xD;
      repeats every 28 days for up to 6 courses in the absence of disease progression or&#xD;
      unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 3 and 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    slow accrual&#xD;
  </why_stopped>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">June 14, 2016</completion_date>
  <primary_completion_date type="Actual">June 14, 2016</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of aGVHD</measure>
    <time_frame>At 28 days after initiation of romidepsin</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of cGVHD</measure>
    <time_frame>At 1 month after initiation of romidepsin</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of cGVHD</measure>
    <time_frame>At 3 months after initiation of romidepsin</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of cGVHD</measure>
    <time_frame>At 6 months after initiation of romidepsin</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of cGVHD</measure>
    <time_frame>At 9 months after initiation of romidepsin</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of cGVHD</measure>
    <time_frame>At 12 months after initiation of romidepsin</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Duration of Immunosuppressive Therapy</measure>
    <time_frame>Up to 12 months after initiation of romidepsin</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Documented Infection</measure>
    <time_frame>Up to 12 months after initiation of romidepsin</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T Cell Kinetics - Reconstitution</measure>
    <time_frame>Up to 12 months after initiation of romidepsin</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Graft Versus Host Disease</condition>
  <arm_group>
    <arm_group_label>Supportive care (romidepsin)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>romidepsin</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Supportive care (romidepsin)</arm_group_label>
    <other_name>FK228</other_name>
    <other_name>FR901228</other_name>
    <other_name>Istodax</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laboratory biomarker analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Supportive care (romidepsin)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with steroid (or immunosuppressive therapy [IST]) refractory acute GVHD&#xD;
             (aGVHD) or chronic GVHD (cGVHD)&#xD;
&#xD;
          -  Absolute neutrophil count &gt;= 750/mm^3&#xD;
&#xD;
          -  Platelet count &gt;= 50,000/mm^3&#xD;
&#xD;
          -  Corrected QT interval (QTc) =&lt; 480 msec&#xD;
&#xD;
          -  Bilirubin =&lt; 1.5 x upper limit of normal (ULN)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and&#xD;
             alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =&lt; 3 x&#xD;
             ULN&#xD;
&#xD;
          -  Serum potassium &gt;= 3.8 mmol/L&#xD;
&#xD;
          -  Serum magnesium &gt;= 1.8 mg/dL&#xD;
&#xD;
          -  Serum creatinine =&lt; 2.0 mg/dl&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3&#xD;
&#xD;
          -  Patients may undergo electrolyte repletion therapy to meet eligibility requirements&#xD;
&#xD;
          -  Patients must be scheduled for tapering doses of (or no longer treated with):&#xD;
&#xD;
               -  Cyclosporine;&#xD;
&#xD;
               -  Tacrolimus;&#xD;
&#xD;
               -  Sirolimus;&#xD;
&#xD;
               -  Steroids (patients may be on physiologic doses of steroids)&#xD;
&#xD;
          -  Patients receiving extracorporeal photopheresis must discontinue extracorporeal&#xD;
             photopheresis or placed on a tapering schedule;&#xD;
&#xD;
          -  Any prior therapy for GVHD must be completed and discontinued with the exception of&#xD;
             the above;&#xD;
&#xD;
          -  Patients with breakpoint cluster region (bcr)-ABL proto-oncogene 1 (abl) associated&#xD;
             malignancies may be on a tyrosine kinase inhibitor as malignant disease therapy or&#xD;
             prophylaxis&#xD;
&#xD;
          -  There must be no uncontrolled active infections or medical conditions that the&#xD;
             investigator feels will compromise the safety of the treatment and/or the assessment&#xD;
             of the efficacy of therapy&#xD;
&#xD;
          -  The patient must be aware of the high risk and experimental nature of the treatment&#xD;
             and provide informed consent&#xD;
&#xD;
          -  Negative serum pregnancy test at the time of enrollment for females of childbearing&#xD;
             potential&#xD;
&#xD;
          -  For males and females of child-producing potential, use of effective contraceptive&#xD;
             methods during the study and for at least 6 months after the last dose of romidepsin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active/uncontrolled infection&#xD;
&#xD;
          -  Evidence of relapsed disease&#xD;
&#xD;
          -  Life expectancy &lt; 12 weeks&#xD;
&#xD;
          -  Pregnant or breast feeding females&#xD;
&#xD;
          -  Prior therapy with romidepsin&#xD;
&#xD;
          -  Known seropositive for or active viral infection with human immunodeficiency virus&#xD;
             (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); patients who are&#xD;
             seropositive because of hepatitis B virus vaccine are eligible&#xD;
&#xD;
          -  Any known cardiac abnormalities such as:&#xD;
&#xD;
               -  Congenital long QT syndrome&#xD;
&#xD;
               -  QTc interval &gt;= 480 milliseconds;&#xD;
&#xD;
               -  Myocardial infarction within 6 months of course 1, day 1 (C1D1); subjects with a&#xD;
                  history of myocardial infarction between 6 and 12 months prior to C1D1 who are&#xD;
                  asymptomatic and have had a negative cardiac risk assessment (treadmill stress&#xD;
                  test, nuclear medicine stress test, or stress echocardiogram) since the event may&#xD;
                  participate;&#xD;
&#xD;
               -  Other significant electrocardiogram (ECG) abnormalities including 2nd degree&#xD;
                  atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia&#xD;
                  (ventricular rate less than 50 beats/min);&#xD;
&#xD;
               -  Symptomatic coronary artery disease (CAD), e.g., angina Canadian class II-IV; in&#xD;
                  any patient in whom there is doubt, the patient should have a stress imaging&#xD;
                  study and, if abnormal, angiography to define whether or not CAD is present;&#xD;
&#xD;
               -  An ECG recorded at screening showing evidence of cardiac ischemia (ST depression&#xD;
                  of &gt;= 2 mm, measured from isoelectric line to the ST segment); if in any doubt,&#xD;
                  the patient should have a stress imaging study and, if abnormal, angiography to&#xD;
                  define whether or not CAD is present;&#xD;
&#xD;
               -  Congestive heart failure (CHF) that meets New York Heart Association (NYHA) class&#xD;
                  II to IV definitions and/or ejection fraction &lt; 40% by multi gated acquisition&#xD;
                  (MUGA) scan or &lt; 50% by echocardiogram and/or magnetic resonance imaging (MRI);&#xD;
&#xD;
               -  A known history of sustained ventricular tachycardia (VT), ventricular&#xD;
                  fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently&#xD;
                  addressed with an automatic implantable cardioverter defibrillator (AICD);&#xD;
&#xD;
               -  Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or&#xD;
                  other cause;&#xD;
&#xD;
               -  Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable&#xD;
                  doses of beta-blockers)&#xD;
&#xD;
          -  Uncontrolled hypertension, i.e., blood pressure (BP) of &gt;= 160/95; patients who have a&#xD;
             history of hypertension controlled by medication must be on a stable dose (for at&#xD;
             least one month) and meet all other inclusion criteria; or&#xD;
&#xD;
          -  Patients taking drugs leading to significant QT prolongation must have an ECG prior to&#xD;
             each treatment&#xD;
&#xD;
          -  Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)&#xD;
             inhibitors&#xD;
&#xD;
          -  Concomitant use of medications known to induce a disulfiram-like reaction to alcohol&#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>Roger Strair</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rutgers Cancer Institute of New Jersey</affiliation>
  </overall_official>
  <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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <results_first_submitted>February 13, 2017</results_first_submitted>
  <results_first_submitted_qc>February 13, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 30, 2017</results_first_posted>
  <last_update_submitted>February 13, 2017</last_update_submitted>
  <last_update_submitted_qc>February 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2017</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>Graft vs Host Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Romidepsin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited through the Rutgers Cancer Institute of New Jersey. The study was open to accrual on 11/20/2014 and was closed by the Principal Investigator on 6/14/2016 due to slow accrual.</recruitment_details>
      <pre_assignment_details>We are reporting results on 1 eligible participant.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Supportive Care (Romidepsin)</title>
          <description>Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.&#xD;
romidepsin: Given IV&#xD;
laboratory biomarker analysis: Correlative studies</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants &gt; 18 years old with steroid (or IST) refractory aGVHD or cGVHD were enrolled.</population>
      <group_list>
        <group group_id="B1">
          <title>Supportive Care (Romidepsin)</title>
          <description>Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.&#xD;
romidepsin: Given IV&#xD;
laboratory biomarker analysis: Correlative studies</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49" lower_limit="49" upper_limit="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence of aGVHD</title>
        <time_frame>At 28 days after initiation of romidepsin</time_frame>
        <population>Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Supportive Care (Romidepsin)</title>
            <description>Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.&#xD;
romidepsin: Given IV&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of aGVHD</title>
          <population>Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence of cGVHD</title>
        <time_frame>At 1 month after initiation of romidepsin</time_frame>
        <population>Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Supportive Care (Romidepsin)</title>
            <description>Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.&#xD;
romidepsin: Given IV&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of cGVHD</title>
          <population>Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence of cGVHD</title>
        <time_frame>At 3 months after initiation of romidepsin</time_frame>
        <population>Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Supportive Care (Romidepsin)</title>
            <description>Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.&#xD;
romidepsin: Given IV&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of cGVHD</title>
          <population>Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence of cGVHD</title>
        <time_frame>At 6 months after initiation of romidepsin</time_frame>
        <population>Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Supportive Care (Romidepsin)</title>
            <description>Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.&#xD;
romidepsin: Given IV&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of cGVHD</title>
          <population>Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence of cGVHD</title>
        <time_frame>At 9 months after initiation of romidepsin</time_frame>
        <population>Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Supportive Care (Romidepsin)</title>
            <description>Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.&#xD;
romidepsin: Given IV&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of cGVHD</title>
          <population>Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence of cGVHD</title>
        <time_frame>At 12 months after initiation of romidepsin</time_frame>
        <population>Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Supportive Care (Romidepsin)</title>
            <description>Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.&#xD;
romidepsin: Given IV&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of cGVHD</title>
          <population>Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Duration of Immunosuppressive Therapy</title>
        <time_frame>Up to 12 months after initiation of romidepsin</time_frame>
        <population>Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Supportive Care (Romidepsin)</title>
            <description>Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.&#xD;
romidepsin: Given IV&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Total Duration of Immunosuppressive Therapy</title>
          <population>Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Documented Infection</title>
        <time_frame>Up to 12 months after initiation of romidepsin</time_frame>
        <population>Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Supportive Care (Romidepsin)</title>
            <description>Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.&#xD;
romidepsin: Given IV&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Documented Infection</title>
          <population>Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>T Cell Kinetics - Reconstitution</title>
        <time_frame>Up to 12 months after initiation of romidepsin</time_frame>
        <population>Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Supportive Care (Romidepsin)</title>
            <description>Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.&#xD;
romidepsin: Given IV&#xD;
laboratory biomarker analysis: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>T Cell Kinetics - Reconstitution</title>
          <population>Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected over 60 days.</time_frame>
      <desc>CTCAE version 4.0 was utilized.</desc>
      <group_list>
        <group group_id="E1">
          <title>Supportive Care (Romidepsin)</title>
          <description>Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.&#xD;
romidepsin: Given IV&#xD;
laboratory biomarker analysis: Correlative studies</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Endocarditis infective</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Roger Strair, MD, PhD</name_or_title>
      <organization>Rutgers Cancer Institute of New Jersey</organization>
      <phone>732-235-7298</phone>
      <email>strairrk@cinj.rutgers.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02203578
org study id: 021309
secondary id: NCI-2014-01411
secondary id: 021309
secondary id: P30CA072720
secondary id: Pro2014004116
nct id: NCT02203578
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This pilot clinical trial studies romidepsin in treating patients with graft-versus-host
      disease (GVHD) that has not responded to treatment with steroids. Romidepsin may be an
      effective treatment for graft-versus-host disease caused by a bone marrow or stem cell
      transplant.
PRIMARY OBJECTIVES:

      I. To determine if romidepsin should be developed as a therapy for patients with
      steroid-refractory GVHD.

      OUTLINE:

      Patients receive romidepsin intravenously (IV) over 4 hours on days 1, 8, and 15. Treatment
      repeats every 28 days for up to 6 courses in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed up at 3 and 6 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Incidence of aGVHD
time frame: At 28 days after initiation of romidepsin
measure: Incidence of cGVHD
time frame: At 1 month after initiation of romidepsin
measure: Incidence of cGVHD
time frame: At 3 months after initiation of romidepsin
measure: Incidence of cGVHD
time frame: At 6 months after initiation of romidepsin
measure: Incidence of cGVHD
time frame: At 9 months after initiation of romidepsin
measure: Incidence of cGVHD
time frame: At 12 months after initiation of romidepsin
measure: Total Duration of Immunosuppressive Therapy
time frame: Up to 12 months after initiation of romidepsin
measure: Rate of Documented Infection
time frame: Up to 12 months after initiation of romidepsin
measure: T Cell Kinetics - Reconstitution
time frame: Up to 12 months after initiation of romidepsin
arm group label: Supportive care (romidepsin)
arm group type: Experimental
description: Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: romidepsin
description: Given IV
arm group label: Supportive care (romidepsin)
other name: FK228
other name: FR901228
other name: Istodax
intervention type: Other
intervention name: laboratory biomarker analysis
description: Correlative studies
arm group label: Supportive care (romidepsin)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roger Strair
role: Principal Investigator
affiliation: Rutgers Cancer Institute of New Jersey
facility: 
country: United States
responsible party type: Sponsor
mesh term: Graft vs Host Disease
mesh term: Romidepsin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 