<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/NCT02192619</url>
  </required_header>
  <id_info>
    <org_study_id>NAPOLEON-Registry</org_study_id>
    <nct_id>NCT02192619</nct_id>
  </id_info>
  <brief_title>National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup</brief_title>
  <official_title>National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The registry aims to document epidemiologic data, treatment and long-term outcome as well as&#xD;
      quality of life of patients with APL. Additionally, a biobanking project for further&#xD;
      translational studies is integrated.&#xD;
&#xD;
      Prospective population-based non-interventional and non-randomized multicenter registry.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  collection of epidemiological data for APL: age distribution, prognostic factors,&#xD;
           distribution of subgroups, incidence&#xD;
&#xD;
        -  documentation of efficacy and safety of the first line and salvage therapy in APL&#xD;
           including&#xD;
&#xD;
        -  documentation of minimal residual disease (MRD)&#xD;
&#xD;
        -  correlation of clinical outcomes with chosen therapy&#xD;
&#xD;
        -  collection and evaluation of quality of life&#xD;
&#xD;
        -  validation of published prognostic factors / new potential prognostic factors&#xD;
&#xD;
        -  acquisition of bone marrow, peripheral blood and buccal swab samples for biobanking and&#xD;
           translational studies under the umbrella of the specific study-group biobanking concepts&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>epidemiological parameters</measure>
    <time_frame>yearly follow up for 5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>diagnostic quality indicators</measure>
    <time_frame>yearly follow up for 5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>type of therapy</measure>
    <time_frame>yearly follow up for 5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>response, recurrence and time of death and resulting outcomes RFS and OS</measure>
    <time_frame>yearly follow up for 5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>complete remission (CR) and CRm</measure>
    <time_frame>yearly follow up for 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>treatment related mortality (TRM)</measure>
    <time_frame>yearly follow up for 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cumulative incidence of relapse (CIR)</measure>
    <time_frame>yearly follow up for 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>grade IV toxicities</measure>
    <time_frame>yearly follow up for 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life (QoL): EORTC QLQ-C30</measure>
    <time_frame>yearly follow up for 5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Newly-diagnosed APL (de Novo or Therapy-related)</condition>
  <condition>Relapsed APL</condition>
  <arm_group>
    <arm_group_label>observational</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>observational</intervention_name>
    <arm_group_label>observational</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with newly-diagnosed or relapsed APL (de novo or therapy-related) who require a&#xD;
        therapeutic intervention according to their disease state are the study population within&#xD;
        this registry.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  newly-diagnosed APL (either de novo or therapy-related), within 12 months of diagnosis&#xD;
&#xD;
          -  or relapsed APL, within 12 months of diagnosis of relapse&#xD;
&#xD;
               1. confirmed by the presence of the translocation t(15; 17)&#xD;
&#xD;
               2. and / or confirmed by the detection of the fusion transcript of PML/RARa&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#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>Richard F. Schlenk, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinikum Ulm, for the AML-SG group</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eva Lengfelder, PD Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinikum Mannheim</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dietger Niederwieser, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinikum Leipzig</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Uwe Platzbecker, Prof. Dr.</last_name>
    <phone>+49 351 458 3192</phone>
    <email>Uwe.Platzbecker@medizin.uni-leipzig.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michaela Weier</last_name>
    <phone>+49 351 458 3192</phone>
    <email>michaela.weier@ukdd.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Prof. Dr. U. Platzbecker</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Uwe Platzbecker, Prof. Dr.</last_name>
      <phone>+49 351 458 3192</phone>
      <email>Uwe.Platzbecker@medizin.uni-leipzig.de</email>
    </contact>
    <contact_backup>
      <last_name>Michaela Weier</last_name>
      <phone>+49 351 458 3192</phone>
      <email>michaela.weier@ukdd.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.gmiho.de/</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://www.aml-germany.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>February 22, 2023</last_update_submitted>
  <last_update_submitted_qc>February 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>APL</keyword>
  <keyword>acute promyelocytic leukemia</keyword>
  <keyword>AML M3</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Promyelocytic, Acute</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/NCT02192619
org study id: NAPOLEON-Registry
nct id: NCT02192619
lead sponsor: 
has dmc: No
The registry aims to document epidemiologic data, treatment and long-term outcome as well as
      quality of life of patients with APL. Additionally, a biobanking project for further
      translational studies is integrated.

      Prospective population-based non-interventional and non-randomized multicenter registry.
-  collection of epidemiological data for APL: age distribution, prognostic factors,
           distribution of subgroups, incidence

        -  documentation of efficacy and safety of the first line and salvage therapy in APL
           including

        -  documentation of minimal residual disease (MRD)

        -  correlation of clinical outcomes with chosen therapy

        -  collection and evaluation of quality of life

        -  validation of published prognostic factors / new potential prognostic factors

        -  acquisition of bone marrow, peripheral blood and buccal swab samples for biobanking and
           translational studies under the umbrella of the specific study-group biobanking concepts
observational model: Other
time perspective: Prospective
measure: epidemiological parameters
time frame: yearly follow up for 5 years
measure: diagnostic quality indicators
time frame: yearly follow up for 5 years
measure: type of therapy
time frame: yearly follow up for 5 years
measure: response, recurrence and time of death and resulting outcomes RFS and OS
time frame: yearly follow up for 5 years
measure: complete remission (CR) and CRm
time frame: yearly follow up for 5 years
measure: treatment related mortality (TRM)
time frame: yearly follow up for 5 years
measure: cumulative incidence of relapse (CIR)
time frame: yearly follow up for 5 years
measure: grade IV toxicities
time frame: yearly follow up for 5 years
measure: quality of life (QoL): EORTC QLQ-C30
time frame: yearly follow up for 5 years
arm group label: observational
intervention type: Other
intervention name: observational
arm group label: observational
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard F. Schlenk, Prof. Dr.
role: Principal Investigator
affiliation: Universitätsklinikum Ulm, for the AML-SG group
last name: Eva Lengfelder, PD Dr.
role: Principal Investigator
affiliation: Universitätsklinikum Mannheim
last name: Dietger Niederwieser, Prof. Dr.
role: Principal Investigator
affiliation: Universitätsklinikum Leipzig
last name: Uwe Platzbecker, Prof. Dr.
phone: +49 351 458 3192
email: Uwe.Platzbecker@medizin.uni-leipzig.de
last name: Michaela Weier
phone: +49 351 458 3192
email: michaela.weier@ukdd.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
url: http://www.gmiho.de/
description: Related Info
url: http://www.aml-germany.com/
description: Related Info
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Promyelocytic, Acute