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NCT Number: NCT04794296

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

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.

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Key information

Conditions

Childhood ALL Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Treichville à ABIDJAN, Abidjan, Côte d’Ivoire

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About this study

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:

  • Ensure the feasibility of these recommendations.
  • 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.
  • The survival without relapse of patients in RC will be close to 65% at 5 years.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Feasibility of these recommendations

    Time frame: This can be initially reviewed after the first 2 years and will be evaluated at the end for the community.

    Availability of drugs. This is part of the project as we are working with Low or low to Middle Income countries.

  2. Correct application of therapeutic recommendations

    Time frame: 5 weeks

    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 ?

  3. Complete Remission Rate (CR) close to 85% after induction

    Time frame: J 34 or j42 post start of induction treatment for all children studied.

    Evaluation of the CR j34 or J42 depending on the risk level High or standard.

  4. Ability to follow treatment:

    Time frame: 5 weeks

    The number of children who stop treatment without the consent of the doctor.

  5. Outcome

    Time frame: 5 years

    The vital status at the end of the first line of treatment.

Secondary outcomes

  1. Survival without relapse of patients

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

    the number of children in complete remission without relapse at the end of treatment .

Study contacts

Contact information is provided by the study sponsor or research team.

BRENDA Ms MALLON, MSc

CONTACT

[email protected]

0033142115411

Ndella Ms DIOUF, MD

CONTACT

[email protected]

00(221)77 656 49 13.

Sponsors and collaborators

Lead sponsor

French Africa Pediatric Oncology Group

Other

Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

Registry information

Acronym: LALGFA2019

Important dates

Study start
2021
Primary completion
2028
Study completion
2030
First posted
Mar 12, 2021
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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