Burkitt LymphomaGFALMB2019NCT04425421
Recommendations for the Treatment of Children With Burkitt's Lymphoma
An observational study of Burkitt Lymphoma, run by French Africa Pediatric Oncology Group at 7 sites in 6 countries.
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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Burkitt Lymphoma
- What is being tested?
- OBSERVATIONAL
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 1 Nov 2020to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
Study population: All Children with a Burkitt's Lymhoma.
Who may be able to join
- Clinical diagnosis of Burkitt's Lymphoma: all location. Diagnosis by cytology or histology. Not possible to follow all the treatment.
- -
Who cannot join
- Not a B Cell tumor. Child has been previously treated. Child has also another illness which would render the treatment incompatible. Parents refusal.
Trial locations and contacts
7 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 6 countries
Democratic Republic of the Congo2 sites, 2 recruiting
- Recruiting
Cliniques Universitaires de Kinshasa
Kinshasa, Kinshasa City, BP 12 KIN XI
BUDIONGO Aléine, DR
- Recruiting
Cliniques Universitaires de Lubumbashi (CUL)
Lubumbashi, BP 1825
LUKAMBA Robert, DR, 00(243) 814024633, robertlukamba@yahoo.fr
Burkina Faso1 site, 1 recruiting
- Recruiting
Hopital Yalgado Ouedraogo
Ouagadougou, 03 BP 7022
BOUDA CHANTAL, DR
Côte d’Ivoire1 site, 1 recruiting
- Recruiting
CHU de Treichville à ABIDJAN
Abidjan
Line Dr COUITCHERE, MD, line.couitchere@gfaop.org
Madagascar1 site, 1 recruiting
- Recruiting
HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona
Antananarivo, BP 4150
Mbolanirina RAKOTOMAHEFA, Dr, 34 14 201 51
Mali1 site, 1 recruiting
- Recruiting
CHU Gabriel Touré (HGT)
Bamako
BOUBACAR TOGO, PROFESSEUR, +223 66 74 29 04, boubacar.togo@gfaop.org
Senegal1 site, 1 recruiting
- Recruiting
Hôpital Aristide Le Dantec
Dakar, BP 3001
Fatou-Binetou DIAGNE AKONDE, Dr, 00(221)77 637 40 63
About this study
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.
Read the 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.
- Conditions
- Burkitt Lymphoma
- Being tested
- OBSERVATIONAL
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OBSERVATIONALOther
OBSERVAITON OF THE CAPACITY OF THE GROUP TO TREAT ACCORDING TO THE PROTOCOLE AND LOOK AT OUTCOME FOR STAGE I AND II DISEASE
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: OBSERVATIONAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
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.
Measured: 5 Years
Evaluating the treatment given.
Comparison of treatment given and recommended treatment.
Measured: 5 Years
Evaluating the follow up after treatment.
How many children alive or dead after treatment
Measured: 5 Years
Number of relapse cases
The evaluation and the treatment of relapse and outcome
Measured: 5 years
Secondary outcomes (1)
Application of therapeutic recommendations
Evaluations of the correct application of recommendations
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Nov 2020
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burkitt LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Africa Pediatric Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425421
- Sponsor's protocol ID
- GFA LMB 2019
- Acronym
- GFALMB2019
- Status last verified
- Feb 2026
- First submitted
- 4 Jun 2020
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recommendations for the Treatment of Children With Burkitt's Lymphoma
- ClinicalTrials.gov ID
- NCT04425421
- Acronym / sponsor ID
- GFALMB2019 / GFA LMB 2019
- Conditions
- Burkitt Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- French Africa Pediatric Oncology GroupUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All children with Burkitt lymphoma and in 2 units the addition of Rituximab | – | Other: OBSERVATIONALAn 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 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- All Children with a Burkitt's Lymhoma.
Key inclusion criteria (2 listed)
- Clinical diagnosis of Burkitt's Lymphoma: all location. Diagnosis by cytology or histology. Not possible to follow all the treatment.
- -
Key exclusion criteria (1 listed)
- Not a B Cell tumor. Child has been previously treated. Child has also another illness which would render the treatment incompatible. Parents refusal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OBSERVATIONALOBSERVAITON OF THE CAPACITY OF THE GROUP TO TREAT ACCORDING TO THE PROTOCOLE AND LOOK AT OUTCOME FOR STAGE I AND II DISEASE | Other | All children with Burkitt lymphoma and in 2 units the addition of Rituximab |
Primary outcome
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.
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.
Evaluating the treatment given.
Time frame: 5 Years
Comparison of treatment given and recommended treatment.
Evaluating the follow up after treatment.
Time frame: 5 Years
How many children alive or dead after treatment
Number of relapse cases
Time frame: 5 years
The evaluation and the treatment of relapse and outcome
1 secondary outcome
Application of therapeutic recommendations
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burkitt Lymphoma, run by French Africa Pediatric Oncology Group at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Democratic Republic of the Congo, Burkina Faso, Côte d’Ivoire, Madagascar, Mali and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chantal Ms BOUDA, Dr. (00(226)70 10 01 30, cgbouda@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the number of cases with local disease. (time frame: 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.