<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/NCT02193880</url>
  </required_header>
  <id_info>
    <org_study_id>UAB 1397</org_study_id>
    <nct_id>NCT02193880</nct_id>
  </id_info>
  <brief_title>Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT)</brief_title>
  <acronym>ABD</acronym>
  <official_title>Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ayman Saad</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety and efficacy of post-transplant&#xD;
      cyclophosphamide and a post-transplant infusion of donor cells, that have been specially&#xD;
      processed to remove alpha beta t-cells, in patients undergoing a haploidentical allogeneic&#xD;
      stem cell transplant to help reduce the risk of relapse without increasing the risk of&#xD;
      graft-versus-host disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Transplant patients participating in this clinical trial will receive one of 3 standard&#xD;
      pre-transplant chemotherapy preparative regimens as appropriate for their specific disease.&#xD;
      They will then receive a standard non-manipulated donor stem cell infusion on transplant day&#xD;
      (day 0) followed by cyclophosphamide (days +3 and +4) and an alpha-beta t-cell reduced donor&#xD;
      stem cell infusion on day +7.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 9, 2014</start_date>
  <completion_date type="Actual">March 13, 2018</completion_date>
  <primary_completion_date type="Actual">March 13, 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD)</measure>
    <time_frame>From baseline and before day +100 of transplant.</time_frame>
    <description>Patients will be monitored for Grade IV aGVHD and organ toxicity. Acute assessment will be done using the modified Keystone (Glucksberg) consensus criteria.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD)</measure>
    <time_frame>From baseline and before day +100 of transplant.</time_frame>
    <description>Patients will be monitored for Grade IV cGVHD and organ toxicity. Chronic assessment will be done using the conventional criteria.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Hematologic Neoplasms</condition>
  <condition>Graft-Versus-Host Disease</condition>
  <arm_group>
    <arm_group_label>Alpha-beta depleted T-cell infusion</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.</intervention_name>
    <description>Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.</description>
    <arm_group_label>Alpha-beta depleted T-cell infusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neoplastic hematological disorder with indication of allogeneic transplant&#xD;
&#xD;
          -  No available suitable HLA-matched donor&#xD;
&#xD;
          -  Adequate cardiac, pulmonary, renal, and hepatic function&#xD;
&#xD;
          -  Karnofsky performance status score greater than or equal to 70%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medication non-compliance&#xD;
&#xD;
          -  No appropriate caregiver identified&#xD;
&#xD;
          -  Uncontrolled medical or psychiatric disorder&#xD;
&#xD;
          -  Active central nervous system (CNS) neoplastic involvement&#xD;
&#xD;
          -  Known allergy to Dimethyl Sulfoxide&#xD;
&#xD;
          -  HIV1 or HIV2 positive&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ayman Saad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UAB Medical Center (University of Alabama at Birmingham)</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.uab.edu/medicine/bonemarrow/</url>
    <description>Click here for more information about the Bone Marrow Transplantation and Cell Therapy Program at the University of Alabama at Birmingham.</description>
  </link>
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  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <results_first_submitted>December 17, 2018</results_first_submitted>
  <results_first_submitted_qc>December 17, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">January 8, 2019</results_first_posted>
  <last_update_submitted>April 11, 2019</last_update_submitted>
  <last_update_submitted_qc>April 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Ayman Saad</investigator_full_name>
    <investigator_title>Assoc Prof Medicine M.D.</investigator_title>
  </responsible_party>
  <keyword>stem cell transplant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Neoplasms</mesh_term>
    <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>Cyclophosphamide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>March 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT02193880/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Alpha-beta Depleted T-cell Infusion</title>
          <description>Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.&#xD;
Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>patients did not collect enough HPC</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough T cells.</population>
      <group_list>
        <group group_id="B1">
          <title>Alpha-beta Depleted T-cell Infusion</title>
          <description>Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.&#xD;
Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="48" lower_limit="32" upper_limit="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough T cells.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </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>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD)</title>
        <description>Patients will be monitored for Grade IV aGVHD and organ toxicity. Acute assessment will be done using the modified Keystone (Glucksberg) consensus criteria.</description>
        <time_frame>From baseline and before day +100 of transplant.</time_frame>
        <population>we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough CD34 HSCT..</population>
        <group_list>
          <group group_id="O1">
            <title>Alpha-beta Depleted T-cell Infusion</title>
            <description>Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.&#xD;
Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD)</title>
          <description>Patients will be monitored for Grade IV aGVHD and organ toxicity. Acute assessment will be done using the modified Keystone (Glucksberg) consensus criteria.</description>
          <population>we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough CD34 HSCT..</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </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>Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD)</title>
        <description>Patients will be monitored for Grade IV cGVHD and organ toxicity. Chronic assessment will be done using the conventional criteria.</description>
        <time_frame>From baseline and before day +100 of transplant.</time_frame>
        <population>we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough CD34 HSCT.</population>
        <group_list>
          <group group_id="O1">
            <title>Alpha-beta Depleted T-cell Infusion</title>
            <description>Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.&#xD;
Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD)</title>
          <description>Patients will be monitored for Grade IV cGVHD and organ toxicity. Chronic assessment will be done using the conventional criteria.</description>
          <population>we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough CD34 HSCT.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </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>Baseline through one year.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Alpha-beta Depleted T-cell Infusion</title>
          <description>Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.&#xD;
Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Graft Failure (not related to study)</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Tiffany D Hill</name_or_title>
      <organization>University of Alabama at Birmingham</organization>
      <phone>205-996-8023</phone>
      <email>tiffanydhill@uabmc.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/NCT02193880
org study id: UAB 1397
nct id: NCT02193880
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The purpose of this study is to determine the safety and efficacy of post-transplant
      cyclophosphamide and a post-transplant infusion of donor cells, that have been specially
      processed to remove alpha beta t-cells, in patients undergoing a haploidentical allogeneic
      stem cell transplant to help reduce the risk of relapse without increasing the risk of
      graft-versus-host disease.
Transplant patients participating in this clinical trial will receive one of 3 standard
      pre-transplant chemotherapy preparative regimens as appropriate for their specific disease.
      They will then receive a standard non-manipulated donor stem cell infusion on transplant day
      (day 0) followed by cyclophosphamide (days +3 and +4) and an alpha-beta t-cell reduced donor
      stem cell infusion on day +7.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD)
time frame: From baseline and before day +100 of transplant.
description: Patients will be monitored for Grade IV aGVHD and organ toxicity. Acute assessment will be done using the modified Keystone (Glucksberg) consensus criteria.
measure: Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD)
time frame: From baseline and before day +100 of transplant.
description: Patients will be monitored for Grade IV cGVHD and organ toxicity. Chronic assessment will be done using the conventional criteria.
arm group label: Alpha-beta depleted T-cell infusion
arm group type: Other
description: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
intervention type: Device
intervention name: Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
description: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
arm group label: Alpha-beta depleted T-cell infusion
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ayman Saad, MD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
url: http://www.uab.edu/medicine/bonemarrow/
description: Click here for more information about the Bone Marrow Transplantation and Cell Therapy Program at the University of Alabama at Birmingham.
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responsible party type: Sponsor-Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Ayman Saad
investigator title: Assoc Prof Medicine M.D.
mesh term: Hematologic Neoplasms
mesh term: Graft vs Host Disease
mesh term: Cyclophosphamide
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 