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Recruiting NCT04425421

Recommendations for the Treatment of Children With Burkitt's Lymphoma

Observational Burkitt Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OBSERVATIONAL.
Who it may be relevant to
Registry conditions: Burkitt Lymphoma. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Burkina Faso, Côte d’Ivoire, Democratic Republic of the Congo, Madagascar, Mali +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Evaluation of the number of cases with local disease. [Time frame: 5 years]
  • Evaluation of the number of cases by stage at the time of diagnosis. [Time frame: 5 Years]
  • Evaluating the treatment given. [Time frame: 5 Years]
  • Evaluating the follow up after treatment. [Time frame: 5 Years]
  • Number of relapse cases [Time frame: 5 years]
Secondary outcome measures (1)
  • Application of therapeutic recommendations [Time frame: 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Democratic Republic of the Congo · 2 centers
  • Cliniques Universitaires de Kinshasa — Kinshasa
  • Cliniques Universitaires de Lubumbashi (CUL) — Lubumbashi
Burkina Faso · 1 center
  • Hopital Yalgado Ouedraogo — Ouagadougou
Côte d’Ivoire · 1 center
  • CHU de Treichville à ABIDJAN — Abidjan
Madagascar · 1 center
  • HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona — Antananarivo
Mali · 1 center
  • CHU Gabriel Touré (HGT) — Bamako
Senegal · 1 center
  • Hôpital Aristide Le Dantec — Dakar

Identifiers

NCT: NCT04425421 · GFA LMB 2019

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗