<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/NCT04425421</url>
  </required_header>
  <id_info>
    <org_study_id>GFA LMB 2019</org_study_id>
    <nct_id>NCT04425421</nct_id>
  </id_info>
  <brief_title>Recommendations for the Treatment of Children With Burkitt's Lymphoma</brief_title>
  <acronym>GFALMB2019</acronym>
  <official_title>Recommendations for the Treatment of Children With Burkitt's Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>French Africa Pediatric Oncology Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>French Africa Pediatric Oncology Group</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>
      This is the 4th LMB study by the French African Pediatric Oncology Group (GFAOP). The study&#xD;
      hopes to be able to evaluate children earlier with stage I and II disease and to evaluate&#xD;
      treatment response earlier so that the units can decide if a change in treatment is&#xD;
      necessary, it is also hoped to provide an intensification of treatment for the stage IV&#xD;
      disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is the 4th Burkitt's Lymphoma (LMB) study by the GFAOP group. This study hopes to&#xD;
      include at least 14 Sub Saharian countries some of whom have never participated in a LMB&#xD;
      study. The evaluation of improvement in early diagnosis should be possible in this study. The&#xD;
      study hopes to be able to evaluate children earlier, with stage I and II disease and to&#xD;
      evaluate treatment response earlier so that the units can decide if a change in treatment is&#xD;
      necessary, it is also hoped to provide an intensification of treatment for children with a&#xD;
      stage IV disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Anticipated">October 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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>Evaluation of the number of cases with local disease.</measure>
    <time_frame>5 years</time_frame>
    <description>evaluating the initial clinical reports and later histological reports to confirm the diagnosis and the stage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of the number of cases by stage at the time of diagnosis.</measure>
    <time_frame>5 Years</time_frame>
    <description>evaluating the initial clinical reports and later histological reports to confirm the stage and the diagnosis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluating the treatment given.</measure>
    <time_frame>5 Years</time_frame>
    <description>Comparison of treatment given and recommended treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluating the follow up after treatment.</measure>
    <time_frame>5 Years</time_frame>
    <description>How many children alive or dead after treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of relapse cases</measure>
    <time_frame>5 years</time_frame>
    <description>The evaluation and the treatment of relapse and outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Application of therapeutic recommendations</measure>
    <time_frame>5 years</time_frame>
    <description>Evaluations of the correct application of recommendations</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Burkitt Lymphoma</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>OBSERVATIONAL</intervention_name>
    <description>OBSERVAITON OF THE CAPACITY OF THE GROUP TO TREAT ACCORDING TO THE PROTOCOLE AND LOOK AT OUTCOME FOR STAGE I AND II DISEASE</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All Children with a Burkitt's Lymhoma.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Clinical diagnosis of Burkitt's Lymphoma: all location. Diagnosis by cytology or histology.&#xD;
        Not possible to follow all the treatment.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Not a B Cell tumor. Child has been previously treated. Child has also another illness which&#xD;
        would render the treatment incompatible. Parents refusal.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Chantal Ms BOUDA, Dr.</last_name>
    <phone>00(226)70 10 01 30</phone>
    <email>cgbouda@yahoo.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>BRENDA MALLON, MSc</last_name>
    <phone>0033142115411</phone>
    <email>brenda.mallon@gustaveroussy.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hopital Yalgado Ouedraogo</name>
      <address>
        <city>Ouagadougou</city>
        <zip>03 BP 7022</zip>
        <country>Burkina Faso</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>BOUDA CHANTAL, DR</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires de Kinshasa</name>
      <address>
        <city>Kinshasa</city>
        <zip>BP 12 KIN XI</zip>
        <country>Congo, The Democratic Republic of the</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>BUDIONGO Aléine, DR</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires de Lubumbashi (CUL)</name>
      <address>
        <city>Lubumbashi</city>
        <zip>BP 1825</zip>
        <country>Congo, The Democratic Republic of the</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>LUKAMBA Robert, DR</last_name>
      <phone>00(243) 814024633</phone>
      <email>robertlukamba@yahoo.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Treichville à ABIDJAN</name>
      <address>
        <city>Abidjan</city>
        <country>Côte D'Ivoire</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Line Dr COUITCHERE, MD</last_name>
      <email>line.couitchere@gfaop.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona</name>
      <address>
        <city>Antananarivo</city>
        <zip>BP 4150</zip>
        <country>Madagascar</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mbolanirina RAKOTOMAHEFA, Dr</last_name>
      <phone>34 14 201 51</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Gabriel Touré (HGT)</name>
      <address>
        <city>Bamako</city>
        <country>Mali</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>BOUBACAR TOGO, PROFESSEUR</last_name>
      <phone>+223 66 74 29 04</phone>
      <email>boubacar.togo@gfaop.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Aristide Le Dantec</name>
      <address>
        <city>Dakar</city>
        <zip>BP 3001</zip>
        <country>Senegal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fatou-Binetou DIAGNE AKONDE, Dr</last_name>
      <phone>00(221)77 637 40 63</phone>
    </contact>
  </location>
  <location_countries>
    <country>Burkina Faso</country>
    <country>Congo, The Democratic Republic of the</country>
    <country>Côte D'Ivoire</country>
    <country>Madagascar</country>
    <country>Mali</country>
    <country>Senegal</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>March 16, 2023</last_update_submitted>
  <last_update_submitted_qc>March 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2023</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>Burkitt Lymphoma</mesh_term>
    <mesh_term>Lymphoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04425421
org study id: GFA LMB 2019
nct id: NCT04425421
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is the 4th LMB study by the French African Pediatric Oncology Group (GFAOP). The study
      hopes to be able to evaluate children earlier with stage I and II disease and to evaluate
      treatment response earlier so that the units can decide if a change in treatment is
      necessary, it is also hoped to provide an intensification of treatment for the stage IV
      disease.
This is the 4th Burkitt's Lymphoma (LMB) study by the GFAOP group. This study hopes to
      include at least 14 Sub Saharian countries some of whom have never participated in a LMB
      study. The evaluation of improvement in early diagnosis should be possible in this study. The
      study hopes to be able to evaluate children earlier, with stage I and II disease and to
      evaluate treatment response earlier so that the units can decide if a change in treatment is
      necessary, it is also hoped to provide an intensification of treatment for children with a
      stage IV disease.
observational model: Cohort
time perspective: Prospective
measure: Evaluation of the number of cases with local disease.
time frame: 5 years
description: evaluating the initial clinical reports and later histological reports to confirm the diagnosis and the stage.
measure: Evaluation of the number of cases by stage at the time of diagnosis.
time frame: 5 Years
description: evaluating the initial clinical reports and later histological reports to confirm the stage and the diagnosis.
measure: Evaluating the treatment given.
time frame: 5 Years
description: Comparison of treatment given and recommended treatment.
measure: Evaluating the follow up after treatment.
time frame: 5 Years
description: How many children alive or dead after treatment
measure: Number of relapse cases
time frame: 5 years
description: The evaluation and the treatment of relapse and outcome
measure: Application of therapeutic recommendations
time frame: 5 years
description: Evaluations of the correct application of recommendations
intervention type: Other
intervention name: OBSERVATIONAL
description: OBSERVAITON OF THE CAPACITY OF THE GROUP TO TREAT ACCORDING TO THE PROTOCOLE AND LOOK AT OUTCOME FOR STAGE I AND II DISEASE
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
last name: Chantal Ms BOUDA, Dr.
phone: 00(226)70 10 01 30
email: cgbouda@yahoo.fr
last name: BRENDA MALLON, MSc
phone: 0033142115411
email: brenda.mallon@gustaveroussy.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: 
country: Burkina Faso
country: Congo, The Democratic Republic of the
country: Côte D'Ivoire
country: Madagascar
country: Mali
country: Senegal
responsible party type: Sponsor
mesh term: Burkitt Lymphoma
mesh term: Lymphoma
sharing ipd: Undecided