<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/NCT03232268</url>
  </required_header>
  <id_info>
    <org_study_id>MICROSTEM- IPC 2016-013</org_study_id>
    <nct_id>NCT03232268</nct_id>
  </id_info>
  <brief_title>HLA-mismatched Microtransplantation Without Immunosuppressive Treatment in Patients With Myeloid Hemopathies</brief_title>
  <acronym>MICROSTEM</acronym>
  <official_title>HLA-mismatched Microtransplantation Without Immunosuppressive Treatment in Patients With Myeloid Hemopathies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Paoli-Calmettes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Paoli-Calmettes</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims at evaluating the safety of an approach based on HLA-mismatched&#xD;
      Microtransplantation without immunosuppressive treatment in patients With myeloid hemopathies&#xD;
      who are ineligible to conventional allograft&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 9, 2018</start_date>
  <completion_date type="Anticipated">March 8, 2025</completion_date>
  <primary_completion_date type="Anticipated">March 8, 2022</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of acute Graft versus Host disease after a HLA-mismatched transplantation without an immunosuppressive treatment</measure>
    <time_frame>100 days after transplantation</time_frame>
    <description>Cumulative incidence of acute GVH (grade 1 to 4)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <condition>Myelodysplastic Syndromes</condition>
  <arm_group>
    <arm_group_label>HLA-mismatched microtransplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HLA-mismatched microtransplantation without immunosuppressive treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>HLA-mismatched microtransplantation</intervention_name>
    <description>3 administrations of hematopoietic stem cells without immunosupression</description>
    <arm_group_label>HLA-mismatched microtransplantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt; or = 65 years with a myeloid hemopathy in Complete Remission or Complete&#xD;
             remission with incomplete hematological recovery or Age&lt;65 years with an ineligibility&#xD;
             to allograft (contraindication to conditioning)&#xD;
&#xD;
          -  HLA-partially matched family donors&#xD;
&#xD;
          -  Affiliated to(or beneficiary of) the Social Security&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  AML3&#xD;
&#xD;
          -  Previous Hematopoietic Stem Cell TRansplantation&#xD;
&#xD;
          -  Uncontrolled infection -PS&gt;3 -Other progressive cancer&#xD;
&#xD;
          -  Psychiatric disease&#xD;
&#xD;
          -  Vulnerable person or unable to provide informed consent&#xD;
&#xD;
          -  Emergency&#xD;
&#xD;
          -  Unable to comply with required study follow up&#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_contact>
    <last_name>Dominique Genre, MD</last_name>
    <phone>+ 33 4 91 22 37 78</phone>
    <email>drci.up@ipc.unicancer.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jihane Pakradouni</last_name>
    <phone>+ 33 4 91 22 37 78</phone>
    <email>drci.up@ipc.unicancer.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institut Paoli Calmettes</name>
      <address>
        <city>Marseille</city>
        <state>Bouches Du Rhône</state>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dominique GENRE, MD</last_name>
      <phone>33 4 91 22 37 78</phone>
      <email>drci.up@ipc.unicancer.fr</email>
    </contact>
    <contact_backup>
      <last_name>Jihane Pakradouni, PharmD PhD</last_name>
      <phone>33 4 91 22 37 78</phone>
      <email>drci.up@ipc.unicancer.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Faezeh Izadifar Legrand</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>October 11, 2021</last_update_submitted>
  <last_update_submitted_qc>October 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Microtransplantation</keyword>
  <keyword>Myeloid Hemopathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03232268
org study id: MICROSTEM- IPC 2016-013
nct id: NCT03232268
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims at evaluating the safety of an approach based on HLA-mismatched
      Microtransplantation without immunosuppressive treatment in patients With myeloid hemopathies
      who are ineligible to conventional allograft
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Occurrence of acute Graft versus Host disease after a HLA-mismatched transplantation without an immunosuppressive treatment
time frame: 100 days after transplantation
description: Cumulative incidence of acute GVH (grade 1 to 4)
arm group label: HLA-mismatched microtransplantation
arm group type: Experimental
description: HLA-mismatched microtransplantation without immunosuppressive treatment
intervention type: Biological
intervention name: HLA-mismatched microtransplantation
description: 3 administrations of hematopoietic stem cells without immunosupression
arm group label: HLA-mismatched microtransplantation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dominique Genre, MD
phone: + 33 4 91 22 37 78
email: drci.up@ipc.unicancer.fr
last name: Jihane Pakradouni
phone: + 33 4 91 22 37 78
email: drci.up@ipc.unicancer.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Myelodysplastic Syndromes