GFALMB2019: Recommendations for the Treatment of Children With Burkitt's Lymphoma

Sponsor
French Africa Pediatric Oncology Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT04425421
Collaborator
(none)
1,000
Enrollment
7
Locations
71
Anticipated Duration (Months)
142.9
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: OBSERVATIONAL

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Recommendations for the Treatment of Children With Burkitt's Lymphoma
Actual Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Oct 1, 2026

Outcome Measures

Primary Outcome Measures

  1. Evaluation of the number of cases with local disease. [5 years]

    evaluating the initial clinical reports and later histological reports to confirm the diagnosis and the stage.

  2. Evaluation of the number of cases by stage at the time of diagnosis. [5 Years]

    evaluating the initial clinical reports and later histological reports to confirm the stage and the diagnosis.

  3. Evaluating the treatment given. [5 Years]

    Comparison of treatment given and recommended treatment.

  4. Evaluating the follow up after treatment. [5 Years]

    How many children alive or dead after treatment

  5. Number of relapse cases [5 years]

    The evaluation and the treatment of relapse and outcome

Secondary Outcome Measures

  1. Application of therapeutic recommendations [5 years]

    Evaluations of the correct application of recommendations

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Inclusion Criteria:

Clinical diagnosis of Burkitt's Lymphoma: all location. Diagnosis by cytology or histology. Not possible to follow all the treatment.

-

Exclusion Criteria:

Not a B Cell tumor. Child has been previously treated. Child has also another illness which would render the treatment incompatible. Parents refusal.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Hopital Yalgado OuedraogoOuagadougouBurkina Faso03 BP 7022
2Cliniques Universitaires de KinshasaKinshasaCongo, The Democratic Republic of theBP 12 KIN XI
3Cliniques Universitaires de Lubumbashi (CUL)LubumbashiCongo, The Democratic Republic of theBP 1825
4CHU de Treichville à ABIDJANAbidjanCôte D'Ivoire
5HJRA, Hôpital universitaire Joseph Ravoahangy AndrianavalonaAntananarivoMadagascarBP 4150
6CHU Gabriel Touré (HGT)BamakoMali
7Hôpital Aristide Le DantecDakarSenegalBP 3001

Sponsors and Collaborators

  • French Africa Pediatric Oncology Group

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
French Africa Pediatric Oncology Group
ClinicalTrials.gov Identifier:
NCT04425421
Other Study ID Numbers:
  • GFA LMB 2019
First Posted:
Jun 11, 2020
Last Update Posted:
Oct 27, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 27, 2021