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

February 27, 2026 updated by: French Africa Pediatric Oncology Group
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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. Starting from 2026 we now have the possibility of introducing rituximab into the treatment of African children with Burkitt lymphoma, starting from 15/03/2026. This amendment will prospectively evaluate the toxicity and effectiveness of adding rituximab to the current therapeutic recommendations. These results will be compared with those observed during the first years of implementation in two GFAOP units: specifically, the unit at CHU Yalgado Ouagadougou in Burkina Faso and CHU Treichville in Abidjan, Ivory Coast.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chantal Ms BOUDA, Dr.
  • Phone Number: 00(226)70 10 01 30
  • Email: cgbouda@yahoo.fr

Study Contact Backup

Study Locations

  • Burkina Faso
      • Ouagadougou, Burkina Faso, 03 BP 7022
        • Recruiting
        • Hopital Yalgado Ouedraogo
        • Contact:
          • BOUDA CHANTAL, DR
  • Côte d’Ivoire
      • Abidjan, Côte d’Ivoire
  • Democratic Republic of the Congo
      • Lubumbashi, Democratic Republic of the Congo, BP 1825
        • Recruiting
        • Cliniques Universitaires de Lubumbashi (CUL)
        • Contact:
    • Kinshasa City
      • Kinshasa, Kinshasa City, Democratic Republic of the Congo, BP 12 KIN XI
        • Recruiting
        • Cliniques Universitaires de Kinshasa
        • Contact:
          • BUDIONGO Aléine, DR
  • Madagascar
      • Antananarivo, Madagascar, BP 4150
        • Recruiting
        • HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona
        • Contact:
          • Mbolanirina RAKOTOMAHEFA, Dr
          • Phone Number: 34 14 201 51
  • Mali
      • Bamako, Mali
        • Recruiting
        • CHU Gabriel Touré (HGT)
        • Contact:
  • Senegal
      • Dakar, Senegal, BP 3001
        • Recruiting
        • Hôpital Aristide Le Dantec
        • Contact:
          • Fatou-Binetou DIAGNE AKONDE, Dr
          • Phone Number: 00(221)77 637 40 63

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All Children with a Burkitt's Lymhoma.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All children with Burkitt lymphoma and in 2 units the addition of Rituximab
An amendment has been added to give 4 injections during induction treatments as in the study in adults, that is to say 1 injection on D1 and D6 of each induction treatment, COPM or COPADM depending on the risk group in two centers. It is an amendment of the therapeutic recommendations "GFA LMB2019" which are the basis, the other centers will continue with this GFALMB2019 protocol as is
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating the treatment given.
Time Frame: 5 Years
Comparison of treatment given and recommended treatment.
5 Years
Evaluating the follow up after treatment.
Time Frame: 5 Years
How many children alive or dead after treatment
5 Years
Evaluation of the number of cases with local disease.
Time Frame: 5 years
evaluating the initial clinical reports and later histological reports to confirm the diagnosis and the stage.
5 years
Evaluation of the number of cases by stage at the time of diagnosis.
Time Frame: 5 Years
evaluating the initial clinical reports and later histological reports to confirm the stage and the diagnosis.
5 Years
Number of relapse cases
Time Frame: 5 years
The evaluation and the treatment of relapse and outcome
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Application of therapeutic recommendations
Time Frame: 5 years
Evaluations of the correct application of recommendations
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Africa Pediatric Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

June 4, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GFA LMB 2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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