Recommendations for the Treatment of Children With Acute Lymphoblastic Leukemia in the GFAOP
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Ability to follow treatment:
研究概览
简要总结
The LALGFA2019 Recommendations redefine the standard risk criteria and propose to introduce anthracycline induction in so-called high-risk forms (LAL line T and LAL line B with leukocytosis greater than or equal to 50 G/L or in children less than 1 year of age or more than 10 years of age) as well as Endoxan and Methotrexate in high dose consolidation.
详细描述
A few studies conducted in developing countries confirm that it is possible to significantly improve the prognosis of children with Acute Lymphoblastic Leukemia (ALL) provided that the centres can benefit from a precise and adapted protocol and logistical support.
The GFAOP has been working with units for the past 20 years and this is the second study put in place by the group for the treatment of LAL. The initial study was a feasibility study with the treatment of standard risk LAL. This study GFALAL2019 aims to include both standard and high-risk forms of LAL.
With this study it is hoped to:
- Ensure the feasibility of these recommendations.
- To show that the correct application of the therapeutic recommendations will result in a complete remission rate (CR) close to 85% at the end of the induction treatment.
- The survival without relapse of patients in RC will be close to 65% at 5 years.
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
- •Children 0 to 18 ALL first diagnosis No prior chemotherapy Cytology FAB L1 or L2
排除标准
- •ALL L3 (Burkitt) ALL previously treated with chemotherapy Trisomy 21
结局指标
主要结局
Ability to follow treatment:
时间窗: 5 weeks
The number of children who stop treatment without the consent of the doctor.
Complete Remission Rate (CR) close to 85% after induction
时间窗: J 34 or j42 post start of induction treatment for all children studied.
Evaluation of the CR j34 or J42 depending on the risk level High or standard.
Feasibility of these recommendations
时间窗: This can be initially reviewed after the first 2 years and will be evaluated at the end for the community.
Availability of drugs. This is part of the project as we are working with Low or low to Middle Income countries.
Correct application of therapeutic recommendations
时间窗: 5 weeks
Availability of drugs and adherence to protocol: Some centers may at times have to find locally the chemiotherapy for application of the protocol. The capacity of the units to do this is alos being studied. By looking at why treatment was not given. Was it because of lack of discipline regarding the attendance at the units for treatment, transport, accommodation, or medication not available ?
Outcome
时间窗: 5 years
The vital status at the end of the first line of treatment.
次要结局
- Survival without relapse of patients(first evaluation starts in 2026 so that enough time has elapsed to evaluate.)