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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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