<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/NCT03284593</url>
  </required_header>
  <id_info>
    <org_study_id>14 7344 03</org_study_id>
    <nct_id>NCT03284593</nct_id>
  </id_info>
  <brief_title>Prognostic Factors and the Impact of Various Management of Acute Myeloid Leukemia in Real Life Condition</brief_title>
  <acronym>LAM-BDD</acronym>
  <official_title>Prognostic Factors and the Impact of Various Management of Acute Myeloid Leukemia in Real Life Condition at Toulouse and Bordeaux University Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</source>
  <oversight_info>
    <has_dmc>No</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>
      The treatment of older patients with acute myeloid leukemia that is secondary to previous&#xD;
      myelodysplastic syndrome, myeloproliferative neoplasm, or prior cytotoxic exposure remains&#xD;
      unsatisfactory. We compared patients treated with intensive chemotherapy or azacitidine&#xD;
      within two centres.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">December 2030</completion_date>
  <primary_completion_date type="Anticipated">December 2030</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>Survival</measure>
    <time_frame>2 years</time_frame>
    <description>Survival times</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">199</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>intensive chemotherapy group</arm_group_label>
    <description>patients treated with intensive chemotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Azacitidine group</arm_group_label>
    <description>patients treated with azacitidine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>intensive chemotherapy</intervention_name>
    <arm_group_label>intensive chemotherapy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azacitidine</intervention_name>
    <arm_group_label>Azacitidine group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Diagnosis of acute myeloid leukemia between 2000 and 2014 in 2 hospitals in South of France&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with acute myeloid leukemia&#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>Christian RECHER, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31052</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azacitidine</mesh_term>
  </intervention_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/NCT03284593
org study id: 14 7344 03
nct id: NCT03284593
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The treatment of older patients with acute myeloid leukemia that is secondary to previous
      myelodysplastic syndrome, myeloproliferative neoplasm, or prior cytotoxic exposure remains
      unsatisfactory. We compared patients treated with intensive chemotherapy or azacitidine
      within two centres.
observational model: Cohort
time perspective: Retrospective
measure: Survival
time frame: 2 years
description: Survival times
arm group label: intensive chemotherapy group
description: patients treated with intensive chemotherapy
arm group label: Azacitidine group
description: patients treated with azacitidine
intervention type: Drug
intervention name: intensive chemotherapy
arm group label: intensive chemotherapy group
intervention type: Drug
intervention name: Azacitidine
arm group label: Azacitidine group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christian RECHER, MD
role: Principal Investigator
affiliation: University Hospital, Toulouse
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Azacitidine
sharing ipd: No