Recommendations for the Treatment of Children With Acute Lymphoblastic Leukemia in the GFAOP

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Recommendations for the Treatment of Children With Acute Lymphoblastic Leukemia in the GFAOP

Conditions
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Childhood ALL

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 0 to 18 ALL first diagnosis No prior chemotherapy Cytology FAB L1 or L2 - Exclusion Criteria: ALL L3 (Burkitt) ALL previously treated with chemotherapy Trisomy 21

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of these recommendations | Availability of drugs. This is part of the project as we are working with Low or low to Middle Income countries. | This can be initially reviewed after the first 2 years and will be evaluated at the end for the community. | 
| Correct application of therapeutic recommendations | 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 ? | 5 weeks | 
| Complete Remission Rate (CR) close to 85% after induction | Evaluation of the CR j34 or J42 depending on the risk level High or standard. | J 34 or j42 post start of induction treatment for all children studied. | 
| Ability to follow treatment: | The number of children who stop treatment without the consent of the doctor. | 5 weeks | 
| Outcome | The vital status at the end of the first line of treatment. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival without relapse of patients | the number of children in complete remission without relapse at the end of treatment . | first evaluation starts in 2026 so that enough time has elapsed to evaluate. |