<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/NCT03766763</url>
  </required_header>
  <id_info>
    <org_study_id>PREVENE FILOCLL10</org_study_id>
    <nct_id>NCT03766763</nct_id>
  </id_info>
  <brief_title>Preemptive Therapy for High Risk Chronic Lymphoid Leukemia Stage A</brief_title>
  <official_title>Preemptive Therapy With Venetoclax for High Risk Chronic Lymphoid Leukemia Stage A Patients, a Phase II Trial of the FILO</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>French Innovative Leukemia Organisation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>French Innovative Leukemia Organisation</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Open label, single arm, multicenter phase II trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preemptive therapy with Venetoclax for high risk stage A Chronic Lymphoid Leukemia patients,&#xD;
      a phase II trial of the FILO group.&#xD;
&#xD;
      PREVENE (PREemptive VENEtoclax) trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 22, 2019</start_date>
  <completion_date type="Anticipated">February 1, 2028</completion_date>
  <primary_completion_date type="Actual">January 22, 2022</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete response rate</measure>
    <time_frame>12 months</time_frame>
    <description>according to International Workshop Chronic Lymphoid Leukemia 2008 guidelines and with Minimal Residual Disease inferior to 0.01 percent (as determined by 8-color technique) in bone marrow at month 12.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">82</enrollment>
  <condition>Chronic Lymphoid Leukemia</condition>
  <arm_group>
    <arm_group_label>ARM A VENETOCLAX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VENETOCLAX</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Venetoclax</intervention_name>
    <description>Venetoclax is administered according to the usual schedule an escalating dose from 20 milligram per day the first week, then 50 milligram per day the second week, 100 milligram per day the third week, 200 milligram per day the fourth week and then 400 milligram per day.&#xD;
For patient achieving a Compete Response with Minimal Residual Disease inferior to 0,01 percent in bone marrow at month 12, treatment will be stopped at month18 (18 months for total duration of treatment ).&#xD;
For responding patients at month12 (Complete Response or Partial Response) with bone marrow Minimal Residual Disease inferior to 0.01 percent, treatment will be continued until month 24 (24 months for total duration of treatment).</description>
    <arm_group_label>ARM A VENETOCLAX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Established diagnosis of Chronic Lymphoid Leukemia by International Workshop Chronic&#xD;
             Lymphoid Leukemia 2008 criteria with Matutes score Superior to 3, or Matutes score&#xD;
             egal to 3 with CD200 positive and CD20 low&#xD;
&#xD;
          -  High risk Binet stage A, patients presenting at least 2 from 3 risk factors:&#xD;
             Lymphocytosis Superior to 13 Giga per liter, CD38 positive, beta2 microglobulin&#xD;
             Superior to 2.5 milligram per liter.&#xD;
&#xD;
        Only patients with unmutated status will be treated and followed according to the trial.&#xD;
&#xD;
          -  No prior chemotherapy, radiation or antibody treatment&#xD;
&#xD;
          -  Age Superior to 18 years&#xD;
&#xD;
          -  Life expectancy Superior to 6 months&#xD;
&#xD;
          -  Performance status 0 to 2&#xD;
&#xD;
          -  All parameters for risk stratification present&#xD;
&#xD;
          -  Possibility of follow-up&#xD;
&#xD;
          -  Adequate hepatic function per local laboratory reference range as follows: Aspartate&#xD;
             transaminase and alanine transaminase Superior to 3.0 of upper limit of normal and&#xD;
             Bilirubin inferior or egal to 1.5 of upper limit of normal (unless bilirubin rise is&#xD;
             due to Gilbert's syndrome or of non-hepatic origin).&#xD;
&#xD;
          -  Willingness to accept highly effective methods of contraception for the duration of&#xD;
             therapy and 12 months thereafter&#xD;
&#xD;
          -  Women of childbearing potential must have a negative serum (beta-human chorionic&#xD;
             gonadotropin) or urine pregnancy test at Screening.&#xD;
&#xD;
          -  Sign (or their legally-acceptable representatives must sign) an informed consent&#xD;
             document indicating that they understand the purpose of and procedures required for&#xD;
             the study, including biomarkers, and are willing to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Binet Stage A patients with progressive disease according to International Workshop&#xD;
             Chronic Lymphoid Leukemia 2008 criteria&#xD;
&#xD;
          -  Clinically apparent autoimmune cytopenia, in particular antiglobulin test positive&#xD;
             hemolytic anemia (positive antiglobulin test without anemia is not an exclusion&#xD;
             criteria)&#xD;
&#xD;
          -  Active secondary malignancy or chemotherapy/radiotherapy for any neoplastic disease&#xD;
             other than Chronic Lymphoid Leukemia prior to the study&#xD;
&#xD;
          -  Medical condition requiring the long term (estimated to be more than one month) use of&#xD;
             oral corticosteroids&#xD;
&#xD;
          -  Patient refusal to perform the bone marrow biopsy for evaluation points&#xD;
&#xD;
          -  Patients with active bacterial, viral or fungal infection&#xD;
&#xD;
          -  Subject is known to be positive for Human Immunodeficiency Virus&#xD;
&#xD;
          -  Evidence of other clinically significant uncontrolled conditions&#xD;
&#xD;
          -  Treatment with any other investigational agent or participating in another trial&#xD;
             within 30 days prior to entering this study&#xD;
&#xD;
          -  A female patient who is pregnant or breast feeding&#xD;
&#xD;
          -  Concurrent severe diseases which exclude the administration of therapy&#xD;
&#xD;
          -  Richter's syndrome&#xD;
&#xD;
          -  Treatment with any of the following within 7 days prior to the first dose of study&#xD;
             drug: Steroid therapy for anti-neoplastic intent, moderate or strong cytochrome P450&#xD;
             3A inhibitors, moderate or strong cytochrome P450 3A inducers&#xD;
&#xD;
          -  Administration or consumption of any of the following within 3 days prior to the first&#xD;
             dose of study drug: grapefruit or grapefruit products, Seville oranges, star fruit.&#xD;
&#xD;
          -  Prior and concomitant therapy&#xD;
&#xD;
          -  Malabsorption syndrome or other condition that precludes enteral route of&#xD;
             administration&#xD;
&#xD;
          -  Received a live viral vaccination within 6 months prior to the first dose of study&#xD;
             drug. A significant history of renal, neurologic, psychiatric, endocrine, metabolic,&#xD;
             immunologic, cardiovascular, or hepatic disease that, in the opinion of the&#xD;
             investigator, would adversely affect the patient's participation in this study or&#xD;
             interpretation of study outcomes&#xD;
&#xD;
          -  Major surgery within 30 days prior to the first dose of study treatment&#xD;
&#xD;
          -  History of prior other malignancy that could affect compliance with the protocol or&#xD;
             interpretation of results&#xD;
&#xD;
          -  Not affiliated to social security&#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>Vincent LEVY, MD PD</last_name>
    <role>Principal Investigator</role>
    <affiliation>French Innovative Leukemia Organisation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luc-Matthieu FORNECKER, MD</last_name>
    <role>Study Chair</role>
    <affiliation>French Innovative Leukemia Organisation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Delphine NOLLET</last_name>
    <phone>(33) 2 18 37 06 09</phone>
    <email>d.nollet@chu-tours.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu Amiens</name>
      <address>
        <city>Amiens</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Pierre MAROLLEAU, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aline CLAVERT, MD</last_name>
      <phone>+33 2 41 35 45 24</phone>
      <email>aline.clavert@chu-angers.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ch Annecy</name>
      <address>
        <city>Annecy</city>
        <zip>74374</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stéphanie TARDY, MD</last_name>
      <phone>+334 50 63 66 08</phone>
      <email>stardy@ch-annecygenevois.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ch Cote Basque</name>
      <address>
        <city>Bayonne</city>
        <zip>64109</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julie GAY, MD</last_name>
      <phone>+33559443832</phone>
      <email>jgay@ch-cotebasque.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopitaljean Minjoz</name>
      <address>
        <city>Besançon</city>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Annie BRION, MD</last_name>
      <phone>+33381668232</phone>
      <email>abrion@chu-besancon.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH BLOIS</name>
      <address>
        <city>Blois</city>
        <zip>41000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Abderrazak EL YAMANI, MD</last_name>
      <phone>+33254556405</phone>
      <email>elyamaa@ch-blois.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Bergonie</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fontanet BIJOU, MD</last_name>
      <phone>+33556330448</phone>
      <email>f.bijou@bordeaux.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ch Beziers</name>
      <address>
        <city>Béziers</city>
        <zip>34500</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alain SAAD, MD</last_name>
      <phone>+33467357063</phone>
      <email>alain.saad@ch-beziers.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU CAEN</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Pierre VILQUE, MD</last_name>
      <phone>+33231272759</phone>
      <email>vilque-jp@chu-caen.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Privé Sévigné</name>
      <address>
        <city>Cesson-Sévigné</city>
        <zip>35510</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xavier CAHU, Dr</last_name>
      <phone>33 (0)2 23 21 05 50</phone>
      <email>cahu.xavier@yahoo.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu Estaing</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Romain Guieze, MD</last_name>
      <phone>+33473750766</phone>
      <email>rguieze@chu-clermontferrand.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu Creteil</name>
      <address>
        <city>Créteil</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jehan DUPUIS, MD</last_name>
      <phone>+33149812051</phone>
      <email>jehan.dupuis@aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lysiane MOLINA, MD</last_name>
      <phone>+33476765455</phone>
      <email>lmolina@chu-grenoble.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chd Vendee</name>
      <address>
        <city>La Roche-sur-Yon</city>
        <zip>85925</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bruno Villemagne, MD</last_name>
      <phone>+33251446173</phone>
      <email>bruno.villemange@chd-vendee.fr</email>
    </contact>
  </location>
  <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>
    <facility>
      <name>Hopital Huriez</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Franck Morschhauser, MD</last_name>
      <phone>+33220445713</phone>
      <email>franck.morschhauser@chu-lille.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre leon berard</name>
      <address>
        <city>Lyon</city>
        <zip>69008</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne-Sophie MICHALLET, MD</last_name>
      <phone>+33478783737</phone>
      <email>anne-sophie.michallet@lyon.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Paoli Calmette</name>
      <address>
        <city>Marseille</city>
        <zip>130009</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thérèse AURRAN, MD</last_name>
      <phone>+33491223667</phone>
      <email>aurrant@ipc.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Regional Metz Thionville</name>
      <address>
        <city>Metz</city>
        <zip>57085</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philippe CARASSOU, MD</last_name>
      <phone>+333 87 55 33 63</phone>
      <email>p.carassou@chr-metz-thionville.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Bordeaux Pessac</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie-Sarah DILHUYDY, MD</last_name>
      <phone>+33557656511</phone>
      <email>marie-sarah.dilhuydy@chu-bordeaux.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emmanuelle FERRANT, MD</last_name>
      <phone>+33478864521</phone>
      <email>emmanuel.ferrant2@chu-lyon.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Henri Becquerel - Service Hématologie Clinique</name>
      <address>
        <city>Rouen</city>
        <zip>76038</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stéphane LEPRETRE, Pr</last_name>
      <phone>+33 2 32 08 29 46</phone>
      <email>stephane.lepretre@chb.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Bretonneau - Hématologie et Thérapie Cellulaire</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caroline DARTIGEAS, Dr</last_name>
      <phone>02 47 47 37 12</phone>
      <email>c.dartigeas@chu-tours.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.filo-leucemie.org</url>
    <description>French Innovative Leukemia Organization (FILO) internet site</description>
  </link>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</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, Lymphoid</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Venetoclax</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>eCRF</ipd_description>
  </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/NCT03766763
org study id: PREVENE FILOCLL10
nct id: NCT03766763
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Open label, single arm, multicenter phase II trial.
Preemptive therapy with Venetoclax for high risk stage A Chronic Lymphoid Leukemia patients,
      a phase II trial of the FILO group.

      PREVENE (PREemptive VENEtoclax) trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complete response rate
time frame: 12 months
description: according to International Workshop Chronic Lymphoid Leukemia 2008 guidelines and with Minimal Residual Disease inferior to 0.01 percent (as determined by 8-color technique) in bone marrow at month 12.
arm group label: ARM A VENETOCLAX
arm group type: Experimental
description: VENETOCLAX
intervention type: Drug
intervention name: Venetoclax
description: Venetoclax is administered according to the usual schedule an escalating dose from 20 milligram per day the first week, then 50 milligram per day the second week, 100 milligram per day the third week, 200 milligram per day the fourth week and then 400 milligram per day.
For patient achieving a Compete Response with Minimal Residual Disease inferior to 0,01 percent in bone marrow at month 12, treatment will be stopped at month18 (18 months for total duration of treatment ).
For responding patients at month12 (Complete Response or Partial Response) with bone marrow Minimal Residual Disease inferior to 0.01 percent, treatment will be continued until month 24 (24 months for total duration of treatment).
arm group label: ARM A VENETOCLAX
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vincent LEVY, MD PD
role: Principal Investigator
affiliation: French Innovative Leukemia Organisation
last name: Luc-Matthieu FORNECKER, MD
role: Study Chair
affiliation: French Innovative Leukemia Organisation
last name: Delphine NOLLET
phone: (33) 2 18 37 06 09
email: d.nollet@chu-tours.fr
facility: 
status: Recruiting
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facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
url: http://www.filo-leucemie.org
description: French Innovative Leukemia Organization (FILO) internet site
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Lymphoid
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
mesh term: Venetoclax
sharing ipd: No
ipd description: eCRF