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.
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.
Study Type
OBSERVATIONAL
Enrollment
500
CHU de Treichville à ABIDJAN
Abidjan, Côte d’Ivoire
RECRUITINGCHU Donka 030 BP 554
Conakry, Guinea
RECRUITINGHôpital Aristide Le Dantec, Avenue Pasteur,
Dakar, Senegal
RECRUITINGFeasibility of these recommendations
Availability of drugs. This is part of the project as we are working with Low or low to Middle Income countries.
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
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 ?
Time frame: 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.
Time frame: 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.
Time frame: 5 weeks
Outcome
The vital status at the end of the first line of treatment.
Time frame: 5 years
Survival without relapse of patients
the number of children in complete remission without relapse at the end of treatment .
Time frame: first evaluation starts in 2026 so that enough time has elapsed to evaluate.
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