ClinicalTrials.gg
RecruitingNCT04425421GFALMB2019Updated Mar 2, 2026

Recommendations for the Treatment of Children With Burkitt's Lymphoma

An observational study in Burkitt Lymphoma, sponsored by French Africa Pediatric Oncology Group. Recruiting at 7 sites in 6 countries. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-02.

Sponsored by French Africa Pediatric Oncology Group · Observational

From the registry’s dates

  • Started Nov 2020; still recruiting 6 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
Up to 18 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Burkitt Lymphoma

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03

In context

Burkitt Lymphoma

976 studies on the registry are indexed under Burkitt Lymphoma; 159 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 152 across 66 observational studies indexed under Burkitt Lymphoma.

Browse Burkitt Lymphoma studies →

Lead sponsor

French Africa Pediatric Oncology Group is the lead sponsor of 6 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

All Children with a Burkitt's Lymhoma.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

-

Exclusion criteria

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherOBSERVATIONAL

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 years

  2. 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.

    Time frame: 5 Years

  3. Evaluating the treatment given.

    Comparison of treatment given and recommended treatment.

    Time frame: 5 Years

  4. Evaluating the follow up after treatment.

    How many children alive or dead after treatment

    Time frame: 5 Years

  5. Number of relapse cases

    The evaluation and the treatment of relapse and outcome

    Time frame: 5 years

Secondary outcomes

  1. Application of therapeutic recommendations

    Evaluations of the correct application of recommendations

    Time frame: 5 years

07

Study locations

7 of 7 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2020 (actual). Primary completion is estimated for Dec 2028, 97 months after the start.

Of 21 observational studies under Burkitt Lymphoma, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 114. This study's planned 97 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2020
First posted
Jun 11, 2020
StartActual
Nov 1, 2020
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2030
Last update
Mar 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04425421
Lead sponsor
French Africa Pediatric Oncology Group
Responsible party
Sponsor
First posted
Jun 11, 2020
Start date
Nov 1, 2020
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Mar 2, 2026

Study contacts

Chantal Ms BOUDA, Dr.
Contact
cgbouda@yahoo.fr
00(226)70 10 01 30
BRENDA MALLON, MSc PhD
Contact
brenda.mallon@gustaveroussy.fr
0033142115411

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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