<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/NCT03234985</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0351</org_study_id>
    <nct_id>NCT03234985</nct_id>
  </id_info>
  <brief_title>Study of Intracellular Nucleotide Pools Determination as Biomarker of the Efficacy of the Induction Treatment in Acute Myeloid Leukemia</brief_title>
  <acronym>NUCLARA</acronym>
  <official_title>Study of Intracellular Nucleotide Pools Determination as Biomarker of the Efficacy of the Induction Treatment in Acute Myeloid Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      Treatment of acute myeloid leukemia (AML) consists in two main phases: induction and&#xD;
      consolidation. Standard chemotherapy combination for induction treatment associates&#xD;
      cytarabine (AraC), a nucleoside analog, and an anthracycline (most often daunorubucin). About&#xD;
      60-70% of patients achieved complete remission after this standard chemotherapy. As&#xD;
      cytarabine competes with endogenous nucleotides to exert its activity, the aim of this&#xD;
      protocol is to study in vivo the effect of intracellular nucleotide pools on the efficacy of&#xD;
      the induction treatment. Thus, intracellular nucleotides levels will be determined in&#xD;
      peripheral blood mononuclear cells of patients with acute myeloid leukemia before treatment,&#xD;
      and results will be compared with the efficacy of the treatment. This parameter will be&#xD;
      assessed by the achievement of complete remission.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">October 25, 2021</completion_date>
  <primary_completion_date type="Actual">October 25, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Complete remission</measure>
    <time_frame>30 days</time_frame>
    <description>Primary endpoint will be the achievement of complete remission after induction treatment and bone marrow aplasia.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">83</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>acute myeloid leukemia patients</arm_group_label>
    <description>Patients over 18 years with acute myeloid leukemia</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Biological analyses</intervention_name>
    <description>Biological analyses will be realized on samples collected before induction treatment and at the end of bone marrow aplasia i.e. about day 30 to determine the nucleotide pools in peripheral blood mononuclear cells.</description>
    <arm_group_label>acute myeloid leukemia patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients or healthy volunteers over 18 years with acute myeloid leukemia (except acute&#xD;
        myeloid leukemia3)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Patients Inclusion Criteria:&#xD;
&#xD;
          -  age over 18 years&#xD;
&#xD;
          -  acute myeloid leukemia&#xD;
&#xD;
          -  standard induction chemotherapy with cytarabine and daunorubicin&#xD;
&#xD;
          -  patients who received the information and did not object to participate to the study&#xD;
&#xD;
        Patients Exclusion Criteria:&#xD;
&#xD;
        - patients with acute myeloid leukemia 3&#xD;
&#xD;
        healthy volunteers Inclusion Criteria :&#xD;
&#xD;
          -  adults without known hematological disease,&#xD;
&#xD;
          -  adults who received the information and did not object to participate in the study&#xD;
&#xD;
        healthy volunteers Exclusion Criteria :&#xD;
&#xD;
        - Volunteers with known hematological disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Service d'hématologie - Centre Hospitalier Lyon Sud - Hospices Civils de LYON</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>November 14, 2022</last_update_submitted>
  <last_update_submitted_qc>November 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2022</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>
  <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/NCT03234985
org study id: 69HCL17_0351
nct id: NCT03234985
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Treatment of acute myeloid leukemia (AML) consists in two main phases: induction and
      consolidation. Standard chemotherapy combination for induction treatment associates
      cytarabine (AraC), a nucleoside analog, and an anthracycline (most often daunorubucin). About
      60-70% of patients achieved complete remission after this standard chemotherapy. As
      cytarabine competes with endogenous nucleotides to exert its activity, the aim of this
      protocol is to study in vivo the effect of intracellular nucleotide pools on the efficacy of
      the induction treatment. Thus, intracellular nucleotides levels will be determined in
      peripheral blood mononuclear cells of patients with acute myeloid leukemia before treatment,
      and results will be compared with the efficacy of the treatment. This parameter will be
      assessed by the achievement of complete remission.
observational model: Other
time perspective: Prospective
measure: Complete remission
time frame: 30 days
description: Primary endpoint will be the achievement of complete remission after induction treatment and bone marrow aplasia.
arm group label: acute myeloid leukemia patients
description: Patients over 18 years with acute myeloid leukemia
intervention type: Biological
intervention name: Biological analyses
description: Biological analyses will be realized on samples collected before induction treatment and at the end of bone marrow aplasia i.e. about day 30 to determine the nucleotide pools in peripheral blood mononuclear cells.
arm group label: acute myeloid leukemia patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
sharing ipd: No