Recommendations for the Treatment of Children With Burkitt's Lymphoma

Recruiting

• Conditions: Burkitt Lymphoma

• Registration Number: NCT04425421
• Lead Sponsor: French Africa Pediatric Oncology Group

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.

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 Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Start: 2020-11-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of relapse cases	5 years	The evaluation and the treatment of relapse and outcome
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.
Evaluating the treatment given.	5 Years	Comparison of treatment given and recommended treatment.
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.
Evaluating the follow up after treatment.	5 Years	How many children alive or dead after treatment

Secondary Outcome Measures

Name	Time	Method
Application of therapeutic recommendations	5 years	Evaluations of the correct application of recommendations

Trial Locations

Locations (7)

Hopital Yalgado Ouedraogo; 🇧🇫 Ouagadougou, Burkina Faso

Cliniques Universitaires de Kinshasa; 🇨🇩 Kinshasa, Congo, The Democratic Republic of the

CHU de Treichville à ABIDJAN; 🇨🇮 Abidjan, Côte D'Ivoire

Cliniques Universitaires de Lubumbashi (CUL); 🇨🇩 Lubumbashi, Congo, The Democratic Republic of the

Hôpital Aristide Le Dantec; 🇸🇳 Dakar, Senegal

HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona; 🇲🇬 Antananarivo, Madagascar

CHU Gabriel Touré (HGT); 🇲🇱 Bamako, Mali