<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/NCT03287128</url>
  </required_header>
  <id_info>
    <org_study_id>P1612_MYLOR</org_study_id>
    <nct_id>NCT03287128</nct_id>
  </id_info>
  <brief_title>Retrospective Analysis of the Outcome of Patients With Relapsed/Refractory Acute Myeloid Leukemia Included in a Patient Named Program of Gemtuzumab Ozogamicin/Mylotarg®</brief_title>
  <acronym>MYLOR</acronym>
  <official_title>A Retrospective Analysis of the Outcome of Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) Included in a Patient Named Program of Gemtuzumab Ozogamicin/Mylotarg®</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Versailles Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Versailles Hospital</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>
      Gemtuzumab Ozogamicin/Mylotarg® (GO) is a conjugate of a derivative of calicheamicin a potent&#xD;
      antitumor anthracycline antibiotic linked to a recombinant humanized antibody against the&#xD;
      CD33 antigen. Pivotal phase 2 study in relapsed AML adult patients used GO 9 mg/m2 as a&#xD;
      monotherapy on days 1 and 14, and showed a 30% response rate with half CR and CRp (CR with&#xD;
      incomplete platelets recovery). Four randomized studies, 3 in adults and 1 in children,&#xD;
      performed in patients with non-previously treated AML tested the addition of lower doses of&#xD;
      GO ( 3mg or 6 mg/m2) to standard induction chemotherapy and showed benefit on survival&#xD;
      endpoints. Results from these studies were available in 2011 in adults and 2014 in children.&#xD;
      In 2010 the french health agency (ANSM) opened a compassionate patient named program&#xD;
      (authorization for temporary utilization (ATU) program) of GO in relapsed/refractory AML&#xD;
      patients. Patients were orally informed about the status of the GO. From 2010 to 2012 it was&#xD;
      recommended to use GO as a monotherapy at a dose of 9mg/m2 on days 1 and 14 according to the&#xD;
      protocol used in pivotal phase 2 study. After 2012 it was recommended by the health authority&#xD;
      to use GO at the dose of 3 or 6 mg/m2 in addition to chemotherapy regarding the toxicity of&#xD;
      higher dose given once.&#xD;
&#xD;
      From 2010 to 2015 more than 500 AML patients have been included in this ATU program.&#xD;
&#xD;
      The main objective of the study presented here is to assess the efficacy and safety of GO 3&#xD;
      or 6 mg/m2 (single dose or fractionated GO) given in as treatment of relapsed/refractory AML&#xD;
      in adult patients.&#xD;
&#xD;
      The coordinator choose to collect the data from centers that included 10 patients or more&#xD;
      from January 2012 to December 2015.&#xD;
&#xD;
      This represents approximately 420 patients from 33 hematology departments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Anticipated">March 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Remission rate including complete remission (CR) and complete remission with incomplete hematological recovery (CRi).</measure>
    <time_frame>45 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival defined as the time from onset of GO re-treatment for relapsed/refractory AML to the date of death.</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of second remission</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse Free Survival defined as the time from onset of GO retreatment for relapsed/refractory AML to the first event (death or relapse).</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of early deaths</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grade 3 to 5 liver, infectious and cardiac adverse events</measure>
    <time_frame>45 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe adverse events during induction treatment</measure>
    <time_frame>45 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of allogenic transplant among responder's patients with respects to age.</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Leukemia, Myeloid, Acute</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemtuzumab Ozogamicin (GO)</intervention_name>
    <description>patients included in a compassionate patient named program with GO</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Retrospective cohort, using medical charts of relapsing or refractory patients after&#xD;
        intensive chemotherapy included in a compassionate patient named program of Gemtuzumab&#xD;
        Ozogamicin from January 2012 to December 2015 and treated in 30 centers to evaluate the&#xD;
        efficacy and safety of Gemtuzumab Ozogamicin (GO) given in addition to chemotherapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient more than 18 year old;&#xD;
&#xD;
          -  De novo or secondary leukemia.&#xD;
&#xD;
          -  Refractory to standard intensive chemotherapy (defined by the association of&#xD;
             anthracycline and cytarabine, at different doses) or in first relapse.&#xD;
&#xD;
          -  Treated with GO from January 2012 to December 2016.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous treatment with GO&#xD;
&#xD;
          -  AML type 3&#xD;
&#xD;
          -  More than 1 relapse&#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_contact>
    <last_name>Laure MORISSET</last_name>
    <phone>+33-1-39-23-97-85</phone>
    <email>lmorisset@ch-versailles.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>C.H.U. d'Amiens - Hôpital Sud</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Magalie JORIS</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>C.H.U. d'Angers</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mathilde HUNAULT</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>HIA Percy</name>
      <address>
        <city>Clamart</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean Valère MALFUSON</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cécile PAUTAS</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital du Bocage</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Denis CAILLOT</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital André Mignot</name>
      <address>
        <city>Le Chesnay</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juliette LAMBERT</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Hotel Dieu</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierre PETERLIN</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Source</name>
      <address>
        <city>Orléans</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Diana CARP</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Louis</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Emmanuel RAFFOUX</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>C.H. Lyon Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xavier THOMAS</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Brabois Adultes</name>
      <address>
        <city>Vandoeuvre les nancy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caroline BONMATI</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>January 23, 2018</last_update_submitted>
  <last_update_submitted_qc>January 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Versailles Hospital</investigator_affiliation>
    <investigator_full_name>Ms Juliette LAMBERT</investigator_full_name>
    <investigator_title>study Coordinator</investigator_title>
  </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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemtuzumab</mesh_term>
  </intervention_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/NCT03287128
org study id: P1612_MYLOR
nct id: NCT03287128
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Gemtuzumab Ozogamicin/Mylotarg® (GO) is a conjugate of a derivative of calicheamicin a potent
      antitumor anthracycline antibiotic linked to a recombinant humanized antibody against the
      CD33 antigen. Pivotal phase 2 study in relapsed AML adult patients used GO 9 mg/m2 as a
      monotherapy on days 1 and 14, and showed a 30% response rate with half CR and CRp (CR with
      incomplete platelets recovery). Four randomized studies, 3 in adults and 1 in children,
      performed in patients with non-previously treated AML tested the addition of lower doses of
      GO ( 3mg or 6 mg/m2) to standard induction chemotherapy and showed benefit on survival
      endpoints. Results from these studies were available in 2011 in adults and 2014 in children.
      In 2010 the french health agency (ANSM) opened a compassionate patient named program
      (authorization for temporary utilization (ATU) program) of GO in relapsed/refractory AML
      patients. Patients were orally informed about the status of the GO. From 2010 to 2012 it was
      recommended to use GO as a monotherapy at a dose of 9mg/m2 on days 1 and 14 according to the
      protocol used in pivotal phase 2 study. After 2012 it was recommended by the health authority
      to use GO at the dose of 3 or 6 mg/m2 in addition to chemotherapy regarding the toxicity of
      higher dose given once.

      From 2010 to 2015 more than 500 AML patients have been included in this ATU program.

      The main objective of the study presented here is to assess the efficacy and safety of GO 3
      or 6 mg/m2 (single dose or fractionated GO) given in as treatment of relapsed/refractory AML
      in adult patients.

      The coordinator choose to collect the data from centers that included 10 patients or more
      from January 2012 to December 2015.

      This represents approximately 420 patients from 33 hematology departments.
observational model: Cohort
time perspective: Retrospective
measure: Remission rate including complete remission (CR) and complete remission with incomplete hematological recovery (CRi).
time frame: 45 days
measure: Overall survival defined as the time from onset of GO re-treatment for relapsed/refractory AML to the date of death.
time frame: 2 years
measure: Duration of second remission
time frame: 2 years
measure: Relapse Free Survival defined as the time from onset of GO retreatment for relapsed/refractory AML to the first event (death or relapse).
time frame: 2 years
measure: Cumulative incidence of early deaths
time frame: 60 days
measure: Grade 3 to 5 liver, infectious and cardiac adverse events
time frame: 45 days
measure: Severe adverse events during induction treatment
time frame: 45 days
measure: Cumulative incidence of allogenic transplant among responder's patients with respects to age.
time frame: 2 years
intervention type: Drug
intervention name: Gemtuzumab Ozogamicin (GO)
description: patients included in a compassionate patient named program with GO
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Laure MORISSET
phone: +33-1-39-23-97-85
email: lmorisset@ch-versailles.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Versailles Hospital
investigator full name: Ms Juliette LAMBERT
investigator title: study Coordinator
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Gemtuzumab