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

NCT ID: NCT04794296

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-15

Study Completion Date

2030-09-01

Brief Summary

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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

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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

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Childhood ALL

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role collaborator

French Africa Pediatric Oncology Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Treichville à ABIDJAN

Abidjan, , Côte d’Ivoire

Site Status RECRUITING

CHU Donka 030 BP 554

Conakry, , Guinea

Site Status RECRUITING

Hôpital Aristide Le Dantec, Avenue Pasteur,

Dakar, , Senegal

Site Status RECRUITING

Countries

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Côte d’Ivoire Guinea Senegal

Central Contacts

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Ndella Ms DIOUF, MD

Role: CONTACT

00(221)77 656 49 13.

BRENDA Ms MALLON, MSc

Role: CONTACT

0033142115411

Facility Contacts

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LINE COUITCHERE, DOCTOR

Role: primary

Dr Aïssata BARRY, DR

Role: primary

00(224)622300084

NDELLA DIOUF, DOCTOR

Role: primary

Other Identifiers

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LAL-GFAOP2019

Identifier Type: -

Identifier Source: org_study_id

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