<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/NCT04437420</url>
  </required_header>
  <id_info>
    <org_study_id>GIRODON Collection 2020</org_study_id>
    <nct_id>NCT04437420</nct_id>
  </id_info>
  <brief_title>Preclinical Project on the Traitment of Acute Lymphoblastique Leukemia With NVP-BEP800, an Inhibitor of the Heat Shock Protein HSP90</brief_title>
  <acronym>HSP-HEMATO</acronym>
  <official_title>Preclinical Project on the Traitment of Acute Lymphoblastique Leukemia With NVP-BEP800, an Inhibitor of the Heat Shock Protein HSP90</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      NVP-BEP800, a new HSP90 inhibitor, has particularly interesting therapeutic potential and&#xD;
      represents hope in cancer pathologies. While it is currently being tested for solid cancers,&#xD;
      no preclinical study has yet demonstrated its effectiveness in acute lymphoblastique leukemia&#xD;
      (ALL). The investigators wish to study the effects of NVP-BEP800 on two different types of&#xD;
      ALL (T and B-ALL).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Viability on primary ALL samples</measure>
    <time_frame>2 years</time_frame>
    <description>The effect of BEP-800 after 48 hours of treatment on T-ALL and B-ALL will be evaluated by counting viable cells by flow cytometry with a viability marker and specific antibodies to detect leukemia cells.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect on SRC phosphorylation</measure>
    <time_frame>2 years</time_frame>
    <description>The effect of BEP-800 on T-ALL and B-ALL will be evaluated by flow cytometry by measuring HSP90 and SRC (phosphorylated), by intracellular labeling after permeabilization of the cells, 18 hours after treatment with BEP-800.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Acute T Lymphoblastic Leukemia (T-ALL)</condition>
  <condition>Acute B Lymphoblastic Leukemia (B-ALL)</condition>
  <arm_group>
    <arm_group_label>T-ALL</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>B-ALL</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>injection of BEP 800</intervention_name>
    <description>injection of BEP 800</description>
    <arm_group_label>B-ALL</arm_group_label>
    <arm_group_label>T-ALL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>no injection of BEP 800</description>
    <arm_group_label>B-ALL</arm_group_label>
    <arm_group_label>T-ALL</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with acute lymphoblastic leukemia with biological samples stored at the Biology&#xD;
        Technical Platform.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient suffering from acute lymphoblastic leukaemia whose biological samples are kept&#xD;
             at the Biology Technical Platform.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient over 80 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>François GIRODON</last_name>
    <phone>0380295710</phone>
    <phone_ext>+33</phone_ext>
    <email>francois.girodon@chu-dijon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shaliha Bechoua</last_name>
      <email>shaliha.bechoua@chu-dijon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 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>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, Lymphoid</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/NCT04437420
org study id: GIRODON Collection 2020
nct id: NCT04437420
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
NVP-BEP800, a new HSP90 inhibitor, has particularly interesting therapeutic potential and
      represents hope in cancer pathologies. While it is currently being tested for solid cancers,
      no preclinical study has yet demonstrated its effectiveness in acute lymphoblastique leukemia
      (ALL). The investigators wish to study the effects of NVP-BEP800 on two different types of
      ALL (T and B-ALL).
observational model: Cohort
time perspective: Prospective
measure: Viability on primary ALL samples
time frame: 2 years
description: The effect of BEP-800 after 48 hours of treatment on T-ALL and B-ALL will be evaluated by counting viable cells by flow cytometry with a viability marker and specific antibodies to detect leukemia cells.
measure: Effect on SRC phosphorylation
time frame: 2 years
description: The effect of BEP-800 on T-ALL and B-ALL will be evaluated by flow cytometry by measuring HSP90 and SRC (phosphorylated), by intracellular labeling after permeabilization of the cells, 18 hours after treatment with BEP-800.
arm group label: T-ALL
arm group label: B-ALL
intervention type: Drug
intervention name: injection of BEP 800
description: injection of BEP 800
arm group label: B-ALL
arm group label: T-ALL
intervention type: Other
intervention name: Control
description: no injection of BEP 800
arm group label: B-ALL
arm group label: T-ALL
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: François GIRODON
phone: 0380295710
phone ext: +33
email: francois.girodon@chu-dijon.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid