Recommendations for the Treatment of Children With Burkitt's Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 10
- 主要终点
- Number of relapse cases
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Burkitt's Lymphoma: all location. Diagnosis by cytology or histology. Not possible to follow all the treatment.
排除标准
- •Not a B Cell tumor. Child has been previously treated. Child has also another illness which would render the treatment incompatible. Parents refusal.
研究组 & 干预措施
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
干预措施: OBSERVATIONAL (Other)
结局指标
主要结局
Number of relapse cases
时间窗: 5 years
The evaluation and the treatment of relapse and outcome
Evaluation of the number of cases with local disease.
时间窗: 5 years
evaluating the initial clinical reports and later histological reports to confirm the diagnosis and the stage.
Evaluating the treatment given.
时间窗: 5 Years
Comparison of treatment given and recommended treatment.
Evaluation of the number of cases by stage at the time of diagnosis.
时间窗: 5 Years
evaluating the initial clinical reports and later histological reports to confirm the stage and the diagnosis.
Evaluating the follow up after treatment.
时间窗: 5 Years
How many children alive or dead after treatment
次要结局
- Application of therapeutic recommendations(5 years)