Recommendations for the Treatment of Children With Burkitt's Lymphoma

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Evaluation of the number of cases with local disease. [Срок оценки: 5 years]
• Evaluation of the number of cases by stage at the time of diagnosis. [Срок оценки: 5 Years]
• Evaluating the treatment given. [Срок оценки: 5 Years]
• Evaluating the follow up after treatment. [Срок оценки: 5 Years]
• Number of relapse cases [Срок оценки: 5 years]

Вторичные конечные точки (1)

• Application of therapeutic recommendations [Срок оценки: 5 years]

Критерии участия

Критерии включения

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

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Критерии исключения

Not a B Cell tumor. Child has been previously treated. Child has also another illness which would render the treatment incompatible. Parents refusal.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Democratic Republic of the Congo · 2 центра

• Cliniques Universitaires de Kinshasa — Kinshasa
• Cliniques Universitaires de Lubumbashi (CUL) — Lubumbashi

Burkina Faso · 1 центр

• Hopital Yalgado Ouedraogo — Ouagadougou

Côte d’Ivoire · 1 центр

• CHU de Treichville à ABIDJAN — Abidjan

Madagascar · 1 центр

• HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona — Antananarivo

Mali · 1 центр

• CHU Gabriel Touré (HGT) — Bamako

Senegal · 1 центр

• Hôpital Aristide Le Dantec — Dakar

Идентификаторы

NCT: NCT04425421 · GFA LMB 2019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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