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

Childhood ALL Clinical Trial

— LALGFA2019  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04794296
• Other study ID #: LAL-GFAOP2019
• Status: Recruiting
• Start date: November 15, 2021
• Est. completion date: September 1, 2030

Study information

• Verified date: March 2023
• Source: French Africa Pediatric Oncology Group
• Contact: Ndella Ms DIOUF, MD
• Phone: 00(221)77 656 49 13.
• Email: ndella.diouf[@]gfaop.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 1, 2030
• Est. primary completion date: September 1, 2028
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood ALL
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Côte D'Ivoire	CHU de Treichville à ABIDJAN	Abidjan
Guinea	CHU Donka 030 BP 554	Conakry
Senegal	Hôpital Aristide Le Dantec, Avenue Pasteur,	Dakar

Sponsors (2)

Lead Sponsor	Collaborator
French Africa Pediatric Oncology Group	Gustave Roussy, Cancer Campus, Grand Paris

Countries where clinical trial is conducted

Côte D'Ivoire,  Guinea,  Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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.
Primary	Ability to follow treatment:	The number of children who stop treatment without the consent of the doctor.	5 weeks
Primary	Outcome	The vital status at the end of the first line of treatment.	5 years
Secondary	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.