<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/NCT04411043</url>
  </required_header>
  <id_info>
    <org_study_id>T-PLL</org_study_id>
    <nct_id>NCT04411043</nct_id>
  </id_info>
  <brief_title>Observatory of Prolymphocytic Leukemia T</brief_title>
  <acronym>T-PLL</acronym>
  <official_title>Prospective and Retrospective Study Evaluating Epidemiological, Clinical, Molecular and Therapeutic Data of Prolymphocytic Leukemia T</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>French Innovative Leukemia Organisation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>French Innovative Leukemia Organisation</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>
      Prolymphocytic leukemia T is a rare disease representing approximately 2% of mature lymphoid&#xD;
      leukemias and 20% of prolymphocytic leukemias. It mainly affects the elderly with an&#xD;
      aggressive clinical course. It is a hemopathy exhibiting a post thymic T phenotype (Tdt-,&#xD;
      CD1a-, CD5 +, CD2 + and CD7 +), generally CD4 + / CD8-, but also CD4 + / CD8 + or CD8 + /&#xD;
      CD4-.&#xD;
&#xD;
      The main feature of T-PLL is the rearrangement of chromosome 14 involving genes encoding the&#xD;
      T cell receptor complex (TCR) subunits, leading to overexpression of the proto-oncogene TCL1.&#xD;
&#xD;
      On the molecular level, the study of Prolymphocytic leukemia T shows a substantial mutational&#xD;
      activation of the IL2RG-JAK1-JAK3-STAT5B axis.&#xD;
&#xD;
      Patients with Prolymphocytic leukemia T have a poor prognosis, due to a poor response to&#xD;
      conventional chemotherapy. Treatment with the anti-CD52 monoclonal antibody: alemtuzumab has&#xD;
      considerably improved the results, but the responses to treatment are transient; therefore,&#xD;
      patients who obtain a response to alemtuzumab treatment are candidates for stem cell&#xD;
      allograft (TSS) if they are eligible for this procedure. This combined approach extended the&#xD;
      median survival to four years or more. However, new approaches using well-tolerated therapies&#xD;
      that target signaling and survival pathways are necessary for most patients who are unable to&#xD;
      receive intensive chemotherapy, such as JAK STAT axis inhibitors, anti-AKT, or anti BCL2 .&#xD;
&#xD;
      Main objective: Better manage prolymphocytic T leukemias.&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        -  Molecular characterization of prolymphocytic leukemia T.&#xD;
&#xD;
        -  Study of the response to treatment, disease-free survival, overall survival.&#xD;
&#xD;
        -  Impact of prognostic factors on response to treatment, and survival.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Clinical characteristics of prolymphocytic leukemia T</measure>
    <time_frame>from day 0 through study completion, an average of 3 years</time_frame>
    <description>pathology description at diagnosis and its evolution over time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biological characteristics of prolymphocytic leukemia T</measure>
    <time_frame>At day 0 and at relapse, an average of 3 years</time_frame>
    <description>Blood count : Hemoglobin, Leukocytes, Lymphocytes, Platelets, Eosinophils (giga / liters)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Flow cytometry data of bone marrow and blood cells</measure>
    <time_frame>At day 0 and at relapse, an average of 3 years</time_frame>
    <description>Positive or negative immunophenotyping</description>
  </primary_outcome>
  <primary_outcome>
    <measure>karyotype of tumor cells</measure>
    <time_frame>At day 0 and at relapse, an average of 3 years</time_frame>
    <description>karyotipic formula</description>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Prolymphocytic Leukemia</condition>
  <condition>T-cell Leukemia</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Molecular caracterization</intervention_name>
    <description>Prospective and retrospective study evaluating the epidemiological, clinical, molecular and therapeutic data of prolymphocytic leukemias T</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      bone marrow and peripheral blood cells&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with prolymphocytic T leukemia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Man or woman aged 18 or over&#xD;
&#xD;
          -  Patient with prolymphocytic T leukemia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of signature of informed consent&#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>Kamel LARIBI, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>French Innovative Leukemia Organisation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Charles HERBAUX, Dr</last_name>
    <phone>3 20 44 57 13</phone>
    <phone_ext>+33</phone_ext>
    <email>Charles.herbaux@chru-lille.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alexandra FAYAULT</last_name>
    <email>a.fayault@filo-leucemie.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chd Le Mans</name>
      <address>
        <city>Le Mans</city>
        <zip>72000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kamel LARIBI, MD</last_name>
      <phone>+33243434361</phone>
      <email>klaribi@ch-lemans.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>July 26, 2022</last_update_submitted>
  <last_update_submitted_qc>July 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 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, T-Cell</mesh_term>
    <mesh_term>Leukemia, Prolymphocytic</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/NCT04411043
org study id: T-PLL
nct id: NCT04411043
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prolymphocytic leukemia T is a rare disease representing approximately 2% of mature lymphoid
      leukemias and 20% of prolymphocytic leukemias. It mainly affects the elderly with an
      aggressive clinical course. It is a hemopathy exhibiting a post thymic T phenotype (Tdt-,
      CD1a-, CD5 +, CD2 + and CD7 +), generally CD4 + / CD8-, but also CD4 + / CD8 + or CD8 + /
      CD4-.

      The main feature of T-PLL is the rearrangement of chromosome 14 involving genes encoding the
      T cell receptor complex (TCR) subunits, leading to overexpression of the proto-oncogene TCL1.

      On the molecular level, the study of Prolymphocytic leukemia T shows a substantial mutational
      activation of the IL2RG-JAK1-JAK3-STAT5B axis.

      Patients with Prolymphocytic leukemia T have a poor prognosis, due to a poor response to
      conventional chemotherapy. Treatment with the anti-CD52 monoclonal antibody: alemtuzumab has
      considerably improved the results, but the responses to treatment are transient; therefore,
      patients who obtain a response to alemtuzumab treatment are candidates for stem cell
      allograft (TSS) if they are eligible for this procedure. This combined approach extended the
      median survival to four years or more. However, new approaches using well-tolerated therapies
      that target signaling and survival pathways are necessary for most patients who are unable to
      receive intensive chemotherapy, such as JAK STAT axis inhibitors, anti-AKT, or anti BCL2 .

      Main objective: Better manage prolymphocytic T leukemias.

      Secondary objectives:

        -  Molecular characterization of prolymphocytic leukemia T.

        -  Study of the response to treatment, disease-free survival, overall survival.

        -  Impact of prognostic factors on response to treatment, and survival.
observational model: Cohort
time perspective: Prospective
measure: Clinical characteristics of prolymphocytic leukemia T
time frame: from day 0 through study completion, an average of 3 years
description: pathology description at diagnosis and its evolution over time
measure: Biological characteristics of prolymphocytic leukemia T
time frame: At day 0 and at relapse, an average of 3 years
description: Blood count : Hemoglobin, Leukocytes, Lymphocytes, Platelets, Eosinophils (giga / liters)
measure: Flow cytometry data of bone marrow and blood cells
time frame: At day 0 and at relapse, an average of 3 years
description: Positive or negative immunophenotyping
measure: karyotype of tumor cells
time frame: At day 0 and at relapse, an average of 3 years
description: karyotipic formula
intervention type: Behavioral
intervention name: Molecular caracterization
description: Prospective and retrospective study evaluating the epidemiological, clinical, molecular and therapeutic data of prolymphocytic leukemias T
bone marrow and peripheral blood cells
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kamel LARIBI, Dr
role: Principal Investigator
affiliation: French Innovative Leukemia Organisation
last name: Charles HERBAUX, Dr
phone: 3 20 44 57 13
phone ext: +33
email: Charles.herbaux@chru-lille.fr
last name: Alexandra FAYAULT
email: a.fayault@filo-leucemie.org
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, T-Cell
mesh term: Leukemia, Prolymphocytic
sharing ipd: No