Recommendations for the Treatment of Children With Acute Lymphoblastic Leukemia in the GFAOP (LALGFA2019)

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.

Study Overview

• Status: Recruiting
• Conditions: Childhood ALL

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: BRENDA Ms MALLON, MSc; Phone Number: 0033142115411; Email: brenda.mallon@gustaveroussy.fr
• Study Contact Backup: Name: Ndella Ms DIOUF, MD; Phone Number: 00(221)77 656 49 13.; Email: ndella.diouf@gfaop.org

Study Locations

• Côte D'Ivoire
  • Abidjan, Côte D'Ivoire
    • Recruiting
    • CHU de Treichville à ABIDJAN
    • Contact: LINE COUITCHERE, DOCTOR; Email: line.couitchere@gfaop.org
• Guinea
  • Conakry, Guinea
    • Recruiting
    • CHU Donka 030 BP 554
    • Contact: Dr Aïssata BARRY, DR; Phone Number: 00(224)622300084; Email: docteumama@gmail.com
• Senegal
  • Dakar, Senegal, BP 3001
    • Recruiting
    • Hôpital Aristide Le Dantec, Avenue Pasteur,
    • Contact: NDELLA DIOUF, DOCTOR; Email: ndella61@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: N/A

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: French Africa Pediatric Oncology Group
• Collaborators: Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
• Other Study ID Numbers: LAL-GFAOP2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No