<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/NCT02210065</url>
  </required_header>
  <id_info>
    <org_study_id>2013-0620</org_study_id>
    <secondary_id>NCI-2014-02335</secondary_id>
    <nct_id>NCT02210065</nct_id>
  </id_info>
  <brief_title>Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Cytomegalovirus (CMV) Reactivation</brief_title>
  <official_title>The Pre-Emptive Use of Recipient-Derived Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Cytomegalovirus (CMV) Reactivation After Allogeneic Stem Cell Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Miltenyi Biotec B.V. &amp; Co. KG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes (CTLs)&#xD;
      can help control CMV when it reactivates (becomes active again) in patients who receive an&#xD;
      allogeneic stem cell transplant. Researchers also want to learn about the safety of giving&#xD;
      CTLs to patients who have had a stem cell transplant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The CTLs:&#xD;
&#xD;
      Blood (about 34 tablespoons) will be drawn 1 time. The blood will be frozen and stored in a&#xD;
      laboratory at MD Anderson for future use to make the CTLs. If CMV comes back after your&#xD;
      transplant, the blood will be used to create CTLs. To create CTLs, blood cells are grown in&#xD;
      the laboratory and trained to kill CMV. If the blood is not used to make the CTLs within 3&#xD;
      years, it will be destroyed.&#xD;
&#xD;
      CTL Administration:&#xD;
&#xD;
      If your CMV becomes active after your stem cell transplant, you will receive the CTLs through&#xD;
      a needle in your vein over 1-5 minutes one time, within 72 hours after CMV becomes active&#xD;
      again. Before you receive the CTLs, you will receive Benadryl (diphenhydramine) and Tylenol&#xD;
      (acetaminophen) by mouth to help reduce the risk of side effects. This can be done in either&#xD;
      the hospital (if not yet discharged after your transplant) or in the outpatient clinic (if&#xD;
      you are discharged).&#xD;
&#xD;
      Your vital signs will be monitored at the end of the infusion, and then at 30 and 60 minutes&#xD;
      after the infusion. Your oxygen level will be measured by pulse oximetry. For this test, a&#xD;
      clothespin-shaped clip will be placed on your finger for at least 30 minutes. If you are an&#xD;
      outpatient, you will remain in the clinic for at least 1 hour after the CTL infusion.&#xD;
&#xD;
      If the CMV does not become active again after your stem cell transplant, you will not receive&#xD;
      the CTL infusion.&#xD;
&#xD;
      Study Visits:&#xD;
&#xD;
      If the CMV does not become active again after your stem cell transplant, you will not receive&#xD;
      the CTL infusion and your follow-up care will be done as per post-transplant standard of&#xD;
      care.&#xD;
&#xD;
      If you receive the CTL infusion, you will have the tests/procedures listed below.&#xD;
&#xD;
      Within 48 hours before the CTL infusion:&#xD;
&#xD;
        -  You will have a physical exam.&#xD;
&#xD;
        -  Blood (about 6 tablespoons) will be drawn for routine tests and to check your kidney and&#xD;
           liver function. Part of blood draw will be used for a pregnancy test for women who are&#xD;
           able to become pregnant. To take part in this study, you must not be pregnant.&#xD;
&#xD;
      Once a week for 4 weeks, blood (about 4-8 tablespoons) will be drawn to check the level of&#xD;
      CMV infection in your body. This may be done more often, if you doctor thinks it is needed.&#xD;
&#xD;
      About 1, 2, 3, and 4 weeks, and then about 3, 6, and 12 months after the CTL infusion:&#xD;
&#xD;
        -  You will have a physical exam.&#xD;
&#xD;
        -  Blood (about 4 tablespoons) will be drawn for routine tests and to check your kidney and&#xD;
           liver function.&#xD;
&#xD;
      Blood (about 4 tablespoons) will be drawn for tests to learn more about the way the CTLs are&#xD;
      working and how long they last in the body. This blood will be drawn before the CTL infusion,&#xD;
      and then about 2 weeks, 4 weeks, 3 months, and 6 months after the CTL infusion. If possible,&#xD;
      the blood needed for these tests will be collected during blood draws for routine tests so&#xD;
      that no additional needle sticks will be needed.&#xD;
&#xD;
      Follow-Up Visits:&#xD;
&#xD;
      Once a week for 6 weeks, and then about 3, 6, 9, and 12 months after the CTL infusion, you&#xD;
      will be checked for signs of graft-versus-host disease (GVHD) at every clinic visit. You were&#xD;
      told about GVHD at the time of being prepared for transplant.&#xD;
&#xD;
      Length of Study:&#xD;
&#xD;
      Your participation on this study will end after your last follow-up visit about 12 months&#xD;
      after the CTL infusion.&#xD;
&#xD;
      This is an investigational study. The use of CTLs to treat CMV infection is not FDA approved.&#xD;
      At this time, CTLs are only being used to treat infections in research studies.&#xD;
&#xD;
      Up to 105 patients will take part in this study. All will be enrolled at MD Anderson.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 3, 2015</start_date>
  <completion_date type="Actual">May 13, 2019</completion_date>
  <primary_completion_date type="Actual">May 13, 2019</primary_completion_date>
  <phase>Phase 2</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>Number of Participants With Non-Relapse Mortality</measure>
    <time_frame>6 months</time_frame>
    <description>Non-relapse mortality defined as death because of causes other than relapse of the underlying hematological malignancy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Success Rate of Cytotoxic T Cells</measure>
    <time_frame>28 days</time_frame>
    <description>Treatment considered a success if the patient does not require initiation of cytomegalovirus (CMV) anti-viral therapy.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Leukemia</condition>
  <condition>Lymphoma</condition>
  <arm_group>
    <arm_group_label>Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)</intervention_name>
    <description>CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.</description>
    <arm_group_label>Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. STEP 1: Within 30 days of study entry: Patients with a history of bone marrow&#xD;
             disorders including hematological malignancies and aplastic anemia, Myelodysplastic&#xD;
             Syndrome (MDS) and Myeloproliferative disorder (MPD) planning to undergo allogeneic&#xD;
             HSCT with reduced intensity or myeloablative conditioning regimens.&#xD;
&#xD;
          2. Disease status must be complete remission by standard criteria for Lymphoma and Acute&#xD;
             Leukemia patients.&#xD;
&#xD;
          3. Patients with Myelodysplastic Syndrome (MDS) and Myeloproliferative Disorder (MPD)&#xD;
             must have &lt;5% blasts in the bone marrow.&#xD;
&#xD;
          4. Patients with T Cell ALL must be in complete remission and MRD negative (-) by flow&#xD;
             cytometry and molecular studies.&#xD;
&#xD;
          5. Patients &gt;/= 18 years of age.&#xD;
&#xD;
          6. Karnofsky greater than or equal to 80%.&#xD;
&#xD;
          7. CMV seropositive.&#xD;
&#xD;
          8. Donor is either matched related, matched unrelated, mismatched unrelated, or&#xD;
             haploidentical. Cord blood recipients are also eligible.&#xD;
&#xD;
          9. Hgb greater than 10 g/L.&#xD;
&#xD;
         10. Patient or patient's legal representative, parent(s) or guardian able to provide&#xD;
             written informed consent.&#xD;
&#xD;
         11. Negative pregnancy test in female patients of childbearing potential.&#xD;
&#xD;
         12. STEP 2: Eligibility at time of generating and infusing CMV-specific cytotoxic T cells&#xD;
             (adoptive immunotherapy): CMV reactivation defined as CMV DNAemia &gt;/= 137 copies/ml.&#xD;
&#xD;
         13. Evidence of neutrophil engraftment defined as the absolute neutrophil count (ANC)&gt; 0.5&#xD;
             X 10^3/for 3 consecutive days.&#xD;
&#xD;
         14. Clinical status to allow tapering of steroids to less than 0.5 mg/kg/day prednisone or&#xD;
             equivalent.&#xD;
&#xD;
         15. Negative pregnancy test in female patients of childbearing potential.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. STEP 1: Within 30 days of study entry: T cell leukemia or lymphoma.&#xD;
&#xD;
          2. CMV seronegative.&#xD;
&#xD;
          3. Positive for HIV, HBV, HCV, HTLV1 and/or HTLV2.&#xD;
&#xD;
          4. STEP 2: Eligibility at time of generating and infusing CMV-specific cytotoxic T cells&#xD;
             (adoptive immunotherapy): Documented CMV end-organ disease.&#xD;
&#xD;
          5. Patients receiving ATG, or Campath within 28 days of CMV reactivation.&#xD;
&#xD;
          6. Patients with other uncontrolled infections. For bacterial infections, patients must&#xD;
             be receiving definitive therapy and have no signs of progressing infection for 72&#xD;
             hours prior to generating CTLs. For fungal infections patients must be receiving&#xD;
             definitive systemic anti-fungal therapy and have no signs of progressing infection for&#xD;
             1 week prior to generating CTLs. Progressing infection is defined as hemodynamic&#xD;
             instability attributable to sepsis or new symptoms, worsening physical signs or&#xD;
             radiographic findings attributable to infection. Persisting fever without other signs&#xD;
             or symptoms will not be interpreted as progressing infection.&#xD;
&#xD;
          7. Patients who have received donor lymphocyte infusion (DLI) within 28 days.&#xD;
&#xD;
          8. Patients with active acute GVHD grades II-IV.&#xD;
&#xD;
          9. Active and uncontrolled relapse of malignancy.&#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>Betul Oran, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <results_first_submitted>February 6, 2020</results_first_submitted>
  <results_first_submitted_qc>March 10, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 17, 2020</results_first_posted>
  <last_update_submitted>March 10, 2020</last_update_submitted>
  <last_update_submitted_qc>March 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Leukemia</keyword>
  <keyword>Lymphoma</keyword>
  <keyword>Blood And Marrow Transplantation</keyword>
  <keyword>Hematological malignancies</keyword>
  <keyword>Cytotoxic T cells</keyword>
  <keyword>CTL</keyword>
  <keyword>Cytomegalovirus</keyword>
  <keyword>CMV</keyword>
  <keyword>Allogeneic hematopoietic stem cell transplantation</keyword>
  <keyword>HSCT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cytomegalovirus Infections</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 9, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT02210065/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>All participants were registered in UT MD Anderson Cancer Center.</recruitment_details>
      <pre_assignment_details>Five participants did not receive treatment as either they did not have CMV reactivation or had relapse of their primary malignancy and received treatment for relapse.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)</title>
          <description>CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.&#xD;
Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs): CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.</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>
      <group_list>
        <group group_id="B1">
          <title>Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)</title>
          <description>CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.&#xD;
Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs): CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.</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>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>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</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>Number of Participants With Non-Relapse Mortality</title>
        <description>Non-relapse mortality defined as death because of causes other than relapse of the underlying hematological malignancy.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)</title>
            <description>CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.&#xD;
Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs): CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Non-Relapse Mortality</title>
          <description>Non-relapse mortality defined as death because of causes other than relapse of the underlying hematological malignancy.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </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>Success Rate of Cytotoxic T Cells</title>
        <description>Treatment considered a success if the patient does not require initiation of cytomegalovirus (CMV) anti-viral therapy.</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)</title>
            <description>CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.&#xD;
Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs): CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Success Rate of Cytotoxic T Cells</title>
          <description>Treatment considered a success if the patient does not require initiation of cytomegalovirus (CMV) anti-viral therapy.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Death, serious adverse events, and other (non-serious adverse events) were not assessed for the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)</title>
          <description>CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.&#xD;
Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs): CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.</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="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </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="0" subjects_at_risk="0"/>
              </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>Dr. Betul Oran / Associate Professor, Stem Cell Transplantation</name_or_title>
      <organization>U.T. MD Anderson Cancer Center</organization>
      <phone>713-745-2820</phone>
      <email>BOran@mdanderson.org</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/NCT02210065
org study id: 2013-0620
secondary id: NCI-2014-02335
nct id: NCT02210065
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes (CTLs)
      can help control CMV when it reactivates (becomes active again) in patients who receive an
      allogeneic stem cell transplant. Researchers also want to learn about the safety of giving
      CTLs to patients who have had a stem cell transplant.
The CTLs:

      Blood (about 34 tablespoons) will be drawn 1 time. The blood will be frozen and stored in a
      laboratory at MD Anderson for future use to make the CTLs. If CMV comes back after your
      transplant, the blood will be used to create CTLs. To create CTLs, blood cells are grown in
      the laboratory and trained to kill CMV. If the blood is not used to make the CTLs within 3
      years, it will be destroyed.

      CTL Administration:

      If your CMV becomes active after your stem cell transplant, you will receive the CTLs through
      a needle in your vein over 1-5 minutes one time, within 72 hours after CMV becomes active
      again. Before you receive the CTLs, you will receive Benadryl (diphenhydramine) and Tylenol
      (acetaminophen) by mouth to help reduce the risk of side effects. This can be done in either
      the hospital (if not yet discharged after your transplant) or in the outpatient clinic (if
      you are discharged).

      Your vital signs will be monitored at the end of the infusion, and then at 30 and 60 minutes
      after the infusion. Your oxygen level will be measured by pulse oximetry. For this test, a
      clothespin-shaped clip will be placed on your finger for at least 30 minutes. If you are an
      outpatient, you will remain in the clinic for at least 1 hour after the CTL infusion.

      If the CMV does not become active again after your stem cell transplant, you will not receive
      the CTL infusion.

      Study Visits:

      If the CMV does not become active again after your stem cell transplant, you will not receive
      the CTL infusion and your follow-up care will be done as per post-transplant standard of
      care.

      If you receive the CTL infusion, you will have the tests/procedures listed below.

      Within 48 hours before the CTL infusion:

        -  You will have a physical exam.

        -  Blood (about 6 tablespoons) will be drawn for routine tests and to check your kidney and
           liver function. Part of blood draw will be used for a pregnancy test for women who are
           able to become pregnant. To take part in this study, you must not be pregnant.

      Once a week for 4 weeks, blood (about 4-8 tablespoons) will be drawn to check the level of
      CMV infection in your body. This may be done more often, if you doctor thinks it is needed.

      About 1, 2, 3, and 4 weeks, and then about 3, 6, and 12 months after the CTL infusion:

        -  You will have a physical exam.

        -  Blood (about 4 tablespoons) will be drawn for routine tests and to check your kidney and
           liver function.

      Blood (about 4 tablespoons) will be drawn for tests to learn more about the way the CTLs are
      working and how long they last in the body. This blood will be drawn before the CTL infusion,
      and then about 2 weeks, 4 weeks, 3 months, and 6 months after the CTL infusion. If possible,
      the blood needed for these tests will be collected during blood draws for routine tests so
      that no additional needle sticks will be needed.

      Follow-Up Visits:

      Once a week for 6 weeks, and then about 3, 6, 9, and 12 months after the CTL infusion, you
      will be checked for signs of graft-versus-host disease (GVHD) at every clinic visit. You were
      told about GVHD at the time of being prepared for transplant.

      Length of Study:

      Your participation on this study will end after your last follow-up visit about 12 months
      after the CTL infusion.

      This is an investigational study. The use of CTLs to treat CMV infection is not FDA approved.
      At this time, CTLs are only being used to treat infections in research studies.

      Up to 105 patients will take part in this study. All will be enrolled at MD Anderson.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Non-Relapse Mortality
time frame: 6 months
description: Non-relapse mortality defined as death because of causes other than relapse of the underlying hematological malignancy.
measure: Success Rate of Cytotoxic T Cells
time frame: 28 days
description: Treatment considered a success if the patient does not require initiation of cytomegalovirus (CMV) anti-viral therapy.
arm group label: Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)
arm group type: Experimental
description: CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.
intervention type: Biological
intervention name: Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)
description: CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.
arm group label: Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Betul Oran, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Cytomegalovirus Infections
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 