Recommendations for the Treatment of Children With Burkitt's Lymphoma

Burkitt Lymphoma Clinical Trial

— GFALMB2019  

Official title:

Recommendations for the Treatment of Children With Burkitt's Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04425421
• Other study ID #: GFA LMB 2019
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: October 2026

Study information

• Verified date: March 2023
• Source: French Africa Pediatric Oncology Group
• Contact: Chantal Ms BOUDA, Dr.
• Phone: 00(226)70 10 01 30
• Email: cgbouda[@]yahoo.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 2026
• Est. primary completion date: December 2025
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

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

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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.

Related Conditions & MeSH terms

• Burkitt Lymphoma
• Lymphoma

Intervention

Other:
• OBSERVATIONAL
OBSERVAITON OF THE CAPACITY OF THE GROUP TO TREAT ACCORDING TO THE PROTOCOLE AND LOOK AT OUTCOME FOR STAGE I AND II DISEASE

Locations

Country	Name	City	State
Burkina Faso	Hopital Yalgado Ouedraogo	Ouagadougou
Congo, The Democratic Republic of the	Cliniques Universitaires de Kinshasa	Kinshasa
Congo, The Democratic Republic of the	Cliniques Universitaires de Lubumbashi (CUL)	Lubumbashi
Côte D'Ivoire	CHU de Treichville à ABIDJAN	Abidjan
Madagascar	HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona	Antananarivo
Mali	CHU Gabriel Touré (HGT)	Bamako
Senegal	Hôpital Aristide Le Dantec	Dakar

Sponsors (1)

Lead Sponsor	Collaborator
French Africa Pediatric Oncology Group

Countries where clinical trial is conducted

Burkina Faso,  Congo, The Democratic Republic of the,  Côte D'Ivoire,  Madagascar,  Mali,  Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the number of cases with local disease.	evaluating the initial clinical reports and later histological reports to confirm the diagnosis and the stage.	5 years
Primary	Evaluation of the number of cases by stage at the time of diagnosis.	evaluating the initial clinical reports and later histological reports to confirm the stage and the diagnosis.	5 Years
Primary	Evaluating the treatment given.	Comparison of treatment given and recommended treatment.	5 Years
Primary	Evaluating the follow up after treatment.	How many children alive or dead after treatment	5 Years
Primary	Number of relapse cases	The evaluation and the treatment of relapse and outcome	5 years
Secondary	Application of therapeutic recommendations	Evaluations of the correct application of recommendations	5 years