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

NCT04794296 | Recruiting DMC

• 1 other identifier: LAL-GFAOP2019
• Study Type: observational
• Target: 500
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Childhood ALL

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Survival without relapse of patients

  first evaluation starts in 2026 so that enough time has elapsed to evaluate.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• Children 0 to 18 ALL first diagnosis No prior chemotherapy Cytology FAB L1 or L2

You may not qualify if:

• ALL L3 (Burkitt) ALL previously treated with chemotherapy Trisomy 21

Sponsors & Collaborators

• French Africa Pediatric Oncology Group: lead
• Gustave Roussy, Cancer Campus, Grand Paris: collaborator

Study Sites (3)

CHU de Treichville à ABIDJAN

Abidjan, Côte d’Ivoire

RECRUITING

CHU Donka 030 BP 554

Conakry, Guinea

RECRUITING

Hôpital Aristide Le Dantec, Avenue Pasteur,

Dakar, BP 3001, Senegal

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Ndella Ms DIOUF, MD

CONTACT

00(221)77 656 49 13.; ndella.diouf@gfaop.org

BRENDA Ms MALLON, MSc

CONTACT

0033142115411; brenda.mallon@gustaveroussy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: March 12, 2021
• Study Start: November 15, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

GU (1); SE (1); CÔ (1)