xml: <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/NCT06030089</url>
    </required_header>
    <id_info>
      <org_study_id>23-AOIP-01</org_study_id>
      <nct_id>NCT06030089</nct_id>
    </id_info>
    <brief_title>Plasma Dosage of Venetoclax in the Fup of AML Patients Treated With Aza + Ven</brief_title>
    <acronym>VENETACIBLE</acronym>
    <official_title>Plasma Dosage of Venetoclax in the Follow-up of Acute Myeloid Leukemias Ineligible for Intensive Chemotherapy in the First Line of Treatment and Treated With Azacitidine + Venetoclax. Pilot Study VENETACIBLE</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire de Nice</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire de Nice</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 study proposes to correlate the plasma dosage of VEN with the inhibition of its Bcl-2&#xD;
        target during the first treatment cycle. VEN will be measured sequentially during the first&#xD;
        treatment cycle and assess inhibition of its target by measuring the level of phosphorylation&#xD;
        of Bcl-2 serine 70. In parallel, BH3 profiling will be evaluated sequentially. All these&#xD;
        analyses will be correlated with treatment toxicity, response rate and overall patient&#xD;
        survival. This pilot study will highlight the inter-individual variability of this AZA + VEN&#xD;
        combination, and enable to launch a national study via the national cooperative groups to&#xD;
        validate the results and thus ultimately propose a personalized treatment for patients&#xD;
        benefiting from this combination.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 15, 2023</start_date>
    <completion_date type="Anticipated">October 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 15, 2024</primary_completion_date>
    <phase>N/A</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>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Plasmatic dosage</measure>
      <time_frame>Before treatment</time_frame>
      <description>Correlation of VEN plasma levels with inhibition of its Bcl-2 target</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plasmatic dosage</measure>
      <time_frame>At Day 5 of 1st round of chemotherapies</time_frame>
      <description>Correlation of VEN plasma levels with inhibition of its Bcl-2 target</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plasmatic dosage</measure>
      <time_frame>At Day 9 of 1st round of chemotherapies</time_frame>
      <description>Correlation of VEN plasma levels with inhibition of its Bcl-2 target</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plasmatic dosage</measure>
      <time_frame>At 12 months after start of treatment or at relapse whichever comes first</time_frame>
      <description>Correlation of VEN plasma levels with inhibition of its Bcl-2 target</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>1 year</time_frame>
      <description>Evaluate the overall survival</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Acute Myeloid Leukemia</condition>
    <arm_group>
      <arm_group_label>AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Newly diagnosed AML patients</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pharmacokinetic sampling</intervention_name>
      <description>4 blood withdrawals ( before treatment, Day 5, Day 9 and relapse or 12 months after start of treatment) for the plasma dosage of VEN and inhibition of its Bcl-2</description>
      <arm_group_label>AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Vital status determination</intervention_name>
      <description>Survival situation 12 months after start of treament</description>
      <arm_group_label>AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Toxicity assessments</intervention_name>
      <description>Toxicity events</description>
      <arm_group_label>AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Venetoclax and azacitidine combination</intervention_name>
      <description>Response to treatment</description>
      <arm_group_label>AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria :&#xD;
  &#xD;
            -  Patient with acute myeloid leukemia (AML) not eligible for intensive chemotherapy&#xD;
  &#xD;
            -  Patients aged 18 or over&#xD;
  &#xD;
            -  Patient treated with the combination azacitidine (AZA) + venetoclax (VEN)&#xD;
  &#xD;
            -  Patient having signed the study informed consent form&#xD;
  &#xD;
            -  Patient with social security coverage&#xD;
  &#xD;
          Exclusion criteria :&#xD;
  &#xD;
            -  Patients receiving treatment inhibiting or inducing Cytochrome CYP3A4&#xD;
  &#xD;
            -  Presence of an active, uncontrolled infection&#xD;
  &#xD;
            -  Patient participating or having participated in a clinical drug trial in the month&#xD;
               prior to inclusion.&#xD;
  &#xD;
            -  Vulnerable persons&#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>Thomas Cluzeau</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHU of Nice</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Thomas Cluzeau, Pr</last_name>
      <phone>0492035841</phone>
      <email>cluzeau.t@chu-nice.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Valérie FOUSSAT</last_name>
      <phone>0492034011</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hopital la Conception</name>
        <address>
          <city>Marseille</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Geoffroy Venton, MD</last_name>
      </contact>
      <investigator>
        <last_name>Geoffroy Venton, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>CHU de Nice</name>
        <address>
          <city>Nice</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Thomas Cluzeau</last_name>
      </contact>
      <investigator>
        <last_name>Thomas Cluzeau, Pr</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>acute myeloid leukemia</keyword>
    <keyword>venetoclax</keyword>
    <keyword>azacitidine</keyword>
    <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>
      <mesh_term>Venetoclax</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06030089
  org study id: 23-AOIP-01
  nct id: NCT06030089
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study proposes to correlate the plasma dosage of VEN with the inhibition of its Bcl-2
        target during the first treatment cycle. VEN will be measured sequentially during the first
        treatment cycle and assess inhibition of its target by measuring the level of phosphorylation
        of Bcl-2 serine 70. In parallel, BH3 profiling will be evaluated sequentially. All these
        analyses will be correlated with treatment toxicity, response rate and overall patient
        survival. This pilot study will highlight the inter-individual variability of this AZA + VEN
        combination, and enable to launch a national study via the national cooperative groups to
        validate the results and thus ultimately propose a personalized treatment for patients
        benefiting from this combination.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Plasmatic dosage
  time frame: Before treatment
  description: Correlation of VEN plasma levels with inhibition of its Bcl-2 target
  measure: Plasmatic dosage
  time frame: At Day 5 of 1st round of chemotherapies
  description: Correlation of VEN plasma levels with inhibition of its Bcl-2 target
  measure: Plasmatic dosage
  time frame: At Day 9 of 1st round of chemotherapies
  description: Correlation of VEN plasma levels with inhibition of its Bcl-2 target
  measure: Plasmatic dosage
  time frame: At 12 months after start of treatment or at relapse whichever comes first
  description: Correlation of VEN plasma levels with inhibition of its Bcl-2 target
  measure: Overall survival
  time frame: 1 year
  description: Evaluate the overall survival
  arm group label: AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax
  arm group type: Experimental
  description: Newly diagnosed AML patients
  intervention type: Other
  intervention name: Pharmacokinetic sampling
  description: 4 blood withdrawals ( before treatment, Day 5, Day 9 and relapse or 12 months after start of treatment) for the plasma dosage of VEN and inhibition of its Bcl-2
  arm group label: AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax
  intervention type: Other
  intervention name: Vital status determination
  description: Survival situation 12 months after start of treament
  arm group label: AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax
  intervention type: Other
  intervention name: Toxicity assessments
  description: Toxicity events
  arm group label: AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax
  intervention type: Drug
  intervention name: Venetoclax and azacitidine combination
  description: Response to treatment
  arm group label: AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Thomas Cluzeau
  role: Principal Investigator
  affiliation: CHU of Nice
  last name: Thomas Cluzeau, Pr
  phone: 0492035841
  email: cluzeau.t@chu-nice.fr
  last name: Valérie FOUSSAT
  phone: 0492034011
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Leukemia
  mesh term: Leukemia, Myeloid
  mesh term: Leukemia, Myeloid, Acute
  mesh term: Azacitidine
  mesh term: Venetoclax
  sharing ipd: No