NCT04794296

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: French Africa Pediatric Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Childhood ALL

Timeline

• Start date: 2021-11-15
• Primary completion: 2028-12-31
• Completion: 2030-12-31
• First posted: 2021-03-12
• Last updated: 2026-03-02

Locations

3 sites across 3 countries: Côte d’Ivoire, Guinea, Senegal