Clinical trial NCT04794296: Recommendations for the Treatment of Children With Acute Lymphoblastic Leukemia in the GFAOP
Official title: Recommendations for the Treatment of Children With Acute Lymphoblastic Leukemia in the GFAOP
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Childhood ALL
Lead sponsor: French Africa Pediatric Oncology Group
Sponsor class: OTHER
Collaborators: name: Gustave Roussy, Cancer Campus, Grand Paris
First posted: 2021-03-12
Enrollment: 500
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 0 to 18 years of age presenting for treatment in any of the unit selected to carry out the recommandations

Brief summary: 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: 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:

1. Ensure the feasibility of these recommendations.
2. 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.
3. The survival without relapse of patients in RC will be close to 65% at 5 years.

Eligibility criteria: Inclusion Criteria:

Children 0 to 18 ALL first diagnosis No prior chemotherapy Cytology FAB L1 or L2

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Exclusion Criteria:

ALL L3 (Burkitt) ALL previously treated with chemotherapy Trisomy 21

Primary outcomes:
measure: Feasibility of these recommendations
timeFrame: This can be initially reviewed after the first 2 years and will be evaluated at the end for the community.
measure: Correct application of therapeutic recommendations
timeFrame: 5 weeks
measure: Complete Remission Rate (CR) close to 85% after induction
timeFrame: J 34 or j42 post start of induction treatment for all children studied.
measure: Ability to follow treatment:
timeFrame: 5 weeks
measure: Outcome
timeFrame: 5 years
Secondary outcomes:
measure: Survival without relapse of patients
timeFrame: first evaluation starts in 2026 so that enough time has elapsed to evaluate.
Other outcomes:
Locations:
city: Abidjan
country: Côte D'Ivoire
facility: CHU de Treichville à ABIDJAN
city: Conakry
country: Guinea
facility: CHU Donka 030 BP 554
city: Dakar
country: Senegal
facility: Hôpital Aristide Le Dantec, Avenue Pasteur,
Study officials:
References: