<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/NCT03280290</url>
  </required_header>
  <id_info>
    <org_study_id>2010_09</org_study_id>
    <secondary_id>2010-A01231-38</secondary_id>
    <nct_id>NCT03280290</nct_id>
  </id_info>
  <brief_title>Transplant T CD4+ CCR7+ In Hematopoietic Stem Cells Allograft</brief_title>
  <acronym>CCR7-CD4-DPL</acronym>
  <official_title>Partial Selective Depletion in Lymphocytes Transplant T CD4+ CCR7+ in Hematopoeitic Stem Cells Allograft</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a preclinical study prior to the establishment of a cell therapy protocol applicable&#xD;
      to humans.&#xD;
&#xD;
      The main objective is to evaluate the decrease in alloreactivity of TCD4 + population by&#xD;
      partial selective depletion of CD4 + CCR7 + graft to less than 50 % of CD4 + totals. To test&#xD;
      the alloreactivity of donor T lymphocytes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a preclinical study prior to the establishment of a cell therapy protocol applicable&#xD;
      to humans.&#xD;
&#xD;
      The main objective is to evaluate the decrease in alloreactivity of TCD4 + population by&#xD;
      partial selective depletion of CD4 + CCR7 + graft to less than 50 % of CD4 + totals. To test&#xD;
      the alloreactivity of donor T lymphocytes , T lymphocytes CD4 + CCR7 + donor will be&#xD;
      stimulated by mature dendritic cells (DC) derived from recipient circulating monocytes in a&#xD;
      mixed lymphocyte reaction model sensitized ( MLDCR ) , experiencing HLA -compatibility . This&#xD;
      first step will confirm the results previously obtained in a situation incompatible HLA .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2012</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change the lymphocyte proliferation will be evaluated using a scintillation spectrometer</measure>
    <time_frame>1 day, 5 day ,8 day</time_frame>
    <description>Decrease in alloreactivity of TCD4.(composite) Decrease population by partial selective depletion of CD4 + CCR7 + graft to less than 50% of total CD4 +will be evaluated on this basis criteria.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change the functional properties of cells will be evaluated by T-SPOT TB®.</measure>
    <time_frame>1 day, 5 day ,8 day</time_frame>
    <description>Decrease in alloreactivity of TCD4.(composite) Decrease population by partial selective depletion of CD4 + CCR7 + graft to less than 50% of total CD4 +will be evaluated on this basis criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response to anti-infectious immunity</measure>
    <time_frame>24 months</time_frame>
    <description>Measure the anti-infectious immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response to anti-tumor immunity</measure>
    <time_frame>24 months</time_frame>
    <description>Measure the anti-tumor immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Acute Myeloblastic Leukemia</condition>
  <arm_group>
    <arm_group_label>receivers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible for allo-HSCs from peripheral blood stem cells from a compatible donor HLA family (Appendix 1, the pre-transplant assessment must be enabled)&#xD;
In a complete remission rate of leucocytes with ≥ 2G / L&#xD;
Affiliated to social security person or beneficiary of such a scheme.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Donors</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Member of the siblings and HLA-matched A, B, Cw, DR, DQ&#xD;
Eligible to donate peripheral blood stem cells for allo-HSCs (Appendix 2, pre donation assessment must be enabled)&#xD;
Having a rate of circulating lymphocytes ≥ 1 G / L&#xD;
Having a proportion of CD4 + CCR7 + ≥ 80% of the total CD4 T population&#xD;
The statutes CMV and EBV are known (positive or negative).&#xD;
Affiliated to social security person or beneficiary</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>blood</intervention_name>
    <description>assessment pre-donation of hematopoietic stem cells (blood sample)</description>
    <arm_group_label>Donors</arm_group_label>
    <arm_group_label>receivers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion criteria of the receiver anti -infectious immunity&#xD;
&#xD;
          -  Man or woman aged 18-65 years&#xD;
&#xD;
          -  Eligible for allo - HSCs from peripheral blood stem cells from a compatible donor HLA&#xD;
             family (Annex 3 , the pre- transplant assessment must be enabled)&#xD;
&#xD;
          -  In a complete remission rate of leucocytes with ≥ 2G / L&#xD;
&#xD;
          -  Affiliated to social security person or beneficiary of such a scheme.&#xD;
&#xD;
          -  Having signed informed consent&#xD;
&#xD;
        Inclusion criteria for the study of the receiver of anti tumor immunity&#xD;
&#xD;
          -  Man or woman aged 18-65 years&#xD;
&#xD;
          -  Achieved a hyperleucocytic acute myelogenous leukemia ( leukocytes ≥ 20G / L)&#xD;
&#xD;
          -  Patients whose blasts at diagnosis were cryopreserved in the tumor bank of the&#xD;
             University Hospital of Lille (Professor Claude Prudhomme )&#xD;
&#xD;
          -  Eligible for allo - HSCs from peripheral blood stem cells from a compatible donor HLA&#xD;
             family (Annex 3 , the pre- transplant assessment must be enabled)&#xD;
&#xD;
          -  In a complete remission rate of leucocytes with ≥ 2G / L&#xD;
&#xD;
          -  Affiliated to social security person or beneficiary of such a scheme.&#xD;
&#xD;
          -  Having signed informed consent receivers&#xD;
&#xD;
        Inclusion criteria of the donor&#xD;
&#xD;
          -  Man or woman aged 18-65 years&#xD;
&#xD;
          -  Member of the HLA-matched siblings and A, B, Cw, DR, DQ&#xD;
&#xD;
          -  Eligible to donate peripheral blood stem cells for allo-HSCs (Appendix 2, pre donation&#xD;
             assessment must be enabled)&#xD;
&#xD;
          -  Having a rate of circulating lymphocytes ≥ 1 G / L&#xD;
&#xD;
          -  Having a proportion of CD4 + CCR7 + ≥ 80% of the total CD4 T population&#xD;
&#xD;
          -  The statutes CMV and EBV are known (positive or negative).&#xD;
&#xD;
          -  Affiliated to social security person or beneficiary of such a scheme. who signed&#xD;
             informed consent -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Criteria for non inclusion of the pairs donor / Receiver&#xD;
&#xD;
          -  Private person of liberty by judicial or administrative decision&#xD;
&#xD;
          -  Person subject to a measure of legal protection&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#xD;
&#xD;
          -  People do not understand French or understanding with a disability.&#xD;
&#xD;
          -  Major Protected Person in emergency and refusing or unable to give informed consent At&#xD;
             any time, individuals may request to be removed from the study Each subject may come&#xD;
             out of the study by decision of the competent administrative authority of the promoter&#xD;
             and the coordinating investigator but also by decision of a co-investigator or by&#xD;
             decision of the interested himself in accordance with regulations and as mentioned in&#xD;
             the form of obtaining consent.&#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>YAKOUB-AGHA IBRAHIM, Professor</last_name>
    <role>Study Director</role>
    <affiliation>CHRU de Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Diseases of Blood Service HURIEZ hospital CHRU de LILLE</name>
      <address>
        <city>LIlle</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>June 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lymphocytes CD4</keyword>
  <keyword>Lymphocytes CCR7</keyword>
  <keyword>ALLOGRAFT</keyword>
  <keyword>Hematopoietic Stem Cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03280290
org study id: 2010_09
secondary id: 2010-A01231-38
nct id: NCT03280290
lead sponsor: 
has dmc: No
This is a preclinical study prior to the establishment of a cell therapy protocol applicable
      to humans.

      The main objective is to evaluate the decrease in alloreactivity of TCD4 + population by
      partial selective depletion of CD4 + CCR7 + graft to less than 50 % of CD4 + totals. To test
      the alloreactivity of donor T lymphocytes.
This is a preclinical study prior to the establishment of a cell therapy protocol applicable
      to humans.

      The main objective is to evaluate the decrease in alloreactivity of TCD4 + population by
      partial selective depletion of CD4 + CCR7 + graft to less than 50 % of CD4 + totals. To test
      the alloreactivity of donor T lymphocytes , T lymphocytes CD4 + CCR7 + donor will be
      stimulated by mature dendritic cells (DC) derived from recipient circulating monocytes in a
      mixed lymphocyte reaction model sensitized ( MLDCR ) , experiencing HLA -compatibility . This
      first step will confirm the results previously obtained in a situation incompatible HLA .
allocation: Non-Randomized
intervention model: Factorial Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Change the lymphocyte proliferation will be evaluated using a scintillation spectrometer
time frame: 1 day, 5 day ,8 day
description: Decrease in alloreactivity of TCD4.(composite) Decrease population by partial selective depletion of CD4 + CCR7 + graft to less than 50% of total CD4 +will be evaluated on this basis criteria.
measure: Change the functional properties of cells will be evaluated by T-SPOT TB®.
time frame: 1 day, 5 day ,8 day
description: Decrease in alloreactivity of TCD4.(composite) Decrease population by partial selective depletion of CD4 + CCR7 + graft to less than 50% of total CD4 +will be evaluated on this basis criteria.
measure: Response to anti-infectious immunity
time frame: 24 months
description: Measure the anti-infectious immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)
measure: Response to anti-tumor immunity
time frame: 24 months
description: Measure the anti-tumor immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)
arm group label: receivers
arm group type: Experimental
description: Eligible for allo-HSCs from peripheral blood stem cells from a compatible donor HLA family (Appendix 1, the pre-transplant assessment must be enabled)
In a complete remission rate of leucocytes with ≥ 2G / L
Affiliated to social security person or beneficiary of such a scheme.
arm group label: Donors
arm group type: Experimental
description: Member of the siblings and HLA-matched A, B, Cw, DR, DQ
Eligible to donate peripheral blood stem cells for allo-HSCs (Appendix 2, pre donation assessment must be enabled)
Having a rate of circulating lymphocytes ≥ 1 G / L
Having a proportion of CD4 + CCR7 + ≥ 80% of the total CD4 T population
The statutes CMV and EBV are known (positive or negative).
Affiliated to social security person or beneficiary
intervention type: Biological
intervention name: blood
description: assessment pre-donation of hematopoietic stem cells (blood sample)
arm group label: Donors
arm group label: receivers
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: YAKOUB-AGHA IBRAHIM, Professor
role: Study Director
affiliation: CHRU de Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Leukemia, Myeloid, Acute
sharing ipd: No