<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/NCT02188290</url>
  </required_header>
  <id_info>
    <org_study_id>CR-AIR-006</org_study_id>
    <nct_id>NCT02188290</nct_id>
  </id_info>
  <brief_title>Transplant-Related Mortality in Patients Undergoing a Peripheral Blood Stem Cell Transplantation or an Umbilical Cord Blood Transplantation</brief_title>
  <official_title>An Observational Cohort Study on Transplant-Related Mortality in Patients Receiving Either a Hematopoietic Stem Cell Transplantation Without ATIR or an Umbilical Cord Blood Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kiadis Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kiadis Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study CR-AIR-006 is a part of the ATIR clinical development plan and will provide control&#xD;
      data for patients treated with ATIR in clinical studies (e.g. study CR-AIR-007).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Transplant-related mortality</measure>
    <time_frame>Up to 12 months after the transplantation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Up to 12 months after the transplantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of acute and chronic graft versus host disease</measure>
    <time_frame>Up to 12 months after the transplantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>Up to 12 months after the transplantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of acute and chronic graft versus host disease</measure>
    <time_frame>Up to 12 months after the transplantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse-related mortality</measure>
    <time_frame>Up to 12 months after the transplantation</time_frame>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">178</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <condition>Acute Lymphoblastic Leukemia</condition>
  <condition>Myelodysplastic Syndrome</condition>
  <arm_group>
    <arm_group_label>HAPLO group</arm_group_label>
    <description>Control group of all eligible patients who received an HSCT from a haploidentical donor without ATIR administration between 1 January 2006 and 30 June 2013</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MUD group</arm_group_label>
    <description>Control group of eligible patients who received an HSCT from a fully matched unrelated donor between 1 January 2010 and 31 December 2012</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MMUD group</arm_group_label>
    <description>Control group of eligible patients who received an HSCT from a 1-locus mismatched unrelated donor between 1 January 2010 and 31 December 2012</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UCB group</arm_group_label>
    <description>Control group of eligible patients who received a double umbilical cord blood transplantation between 1 January 2010 and 31 December 2012</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients having received a haploidentical hematopoietic stem cell transplantation (HSCT)&#xD;
        between 1 January 2006 and 30 June 2014, an HSCT from an unrelated donor between 1 January&#xD;
        2010 and 31 December 2012, or a double UCB transplantation between 1 January 2010 and 31&#xD;
        December 2012 will be selected from the centers that enrolled patients in study CR-AIR-004&#xD;
        and/or study CR-AIR-007.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any of the following hematologic malignancies:&#xD;
&#xD;
               -  Acute myeloid leukemia (AML) in remission at the time of the transplantation&#xD;
&#xD;
               -  Acute lymphoblastic leukemia (ALL) in remission at the time of the&#xD;
                  transplantation&#xD;
&#xD;
               -  Myelodysplastic syndrome (MDS)&#xD;
&#xD;
          -  Patient received any of the following transplantations:&#xD;
&#xD;
               -  Allogeneic T-cell depleted HSCT without ATIR administration from a haploidentical&#xD;
                  donor between 1 January 2006 and 30 June 2013 (HAPLO group)&#xD;
&#xD;
               -  Allogeneic HSCT from a fully matched or 1-locus mismatched unrelated donor&#xD;
                  between 1 January 2010 and 31 December 2012 (MUD/MMUD groups)&#xD;
&#xD;
               -  Double umbilical cord blood transplantation between 1 January 2010 and 31&#xD;
                  December 2012 with no more than 2 human leukocyte antigen (HLA)-mismatches at&#xD;
                  HLA-A, B, and/or -DR between each of the units and the recipient (UCB group)&#xD;
&#xD;
          -  Male or female, age ≥ 18, ≤ 65 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allogeneic stem cell transplantation prior to the transplantation qualifying for the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeroen Rovers, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Kiadis Pharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ohio State University Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Algemeen Ziekenhuis Sint-Jan</name>
      <address>
        <city>Brugge</city>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jules Bordet</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Niagara Regional Haemophilia Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 3Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maisonneuve-Rosemont Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Würzburg</name>
      <address>
        <city>Würzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academisch Ziekenhuis Maastricht</name>
      <address>
        <city>Maastricht</city>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hammersmith Hospital</name>
      <address>
        <city>London</city>
        <zip>W12 OHS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>October 5, 2015</last_update_submitted>
  <last_update_submitted_qc>October 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Haploidentical donor</keyword>
  <keyword>Unrelated donor</keyword>
  <keyword>Umbilical cord blood</keyword>
  <keyword>Graft versus host disease</keyword>
  <keyword>Transplant-related mortality</keyword>
  <keyword>Hematologic malignancy</keyword>
  <keyword>Hematopoietic Stem Cell Transplantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <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/NCT02188290
org study id: CR-AIR-006
nct id: NCT02188290
lead sponsor: 
has dmc: No
Study CR-AIR-006 is a part of the ATIR clinical development plan and will provide control
      data for patients treated with ATIR in clinical studies (e.g. study CR-AIR-007).
observational model: Cohort
time perspective: Retrospective
measure: Transplant-related mortality
time frame: Up to 12 months after the transplantation
measure: Overall survival
time frame: Up to 12 months after the transplantation
measure: Incidence of acute and chronic graft versus host disease
time frame: Up to 12 months after the transplantation
measure: Progression-free survival
time frame: Up to 12 months after the transplantation
measure: Severity of acute and chronic graft versus host disease
time frame: Up to 12 months after the transplantation
measure: Relapse-related mortality
time frame: Up to 12 months after the transplantation
arm group label: HAPLO group
description: Control group of all eligible patients who received an HSCT from a haploidentical donor without ATIR administration between 1 January 2006 and 30 June 2013
arm group label: MUD group
description: Control group of eligible patients who received an HSCT from a fully matched unrelated donor between 1 January 2010 and 31 December 2012
arm group label: MMUD group
description: Control group of eligible patients who received an HSCT from a 1-locus mismatched unrelated donor between 1 January 2010 and 31 December 2012
arm group label: UCB group
description: Control group of eligible patients who received a double umbilical cord blood transplantation between 1 January 2010 and 31 December 2012
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jeroen Rovers, MD
role: Study Chair
affiliation: Kiadis Pharma
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Canada
country: Germany
country: Netherlands
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Myelodysplastic Syndromes