Recommendations for the Treatment of Children With Acute Lymphoblastic Leukemia in the GFAOP
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Childhood ALL. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Côte d’Ivoire, Guinea, Senegal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Feasibility of these recommendations [Time frame: 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 [Time frame: 5 weeks]
- Complete Remission Rate (CR) close to 85% after induction [Time frame: J 34 or j42 post start of induction treatment for all children studied.]
- Ability to follow treatment: [Time frame: 5 weeks]
- Outcome [Time frame: 5 years]
Secondary outcome measures (1)
- Survival without relapse of patients [Time frame: first evaluation starts in 2026 so that enough time has elapsed to evaluate.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Côte d’Ivoire · 1 center
- CHU de Treichville à ABIDJAN — Abidjan
Guinea · 1 center
- CHU Donka 030 BP 554 — Conakry
Senegal · 1 center
- Hôpital Aristide Le Dantec, Avenue Pasteur, — Dakar
Identifiers
NCT: NCT04794296 · LAL-GFAOP2019