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

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ClinicalTrials.gov Identifier: NCT04794296
Recruitment Status : Recruiting
First Posted : March 12, 2021
Last Update Posted : November 22, 2021
Sponsor:
Collaborator:
Gustave Roussy, Cancer Campus, Grand Paris
Information provided by (Responsible Party):
French Africa Pediatric Oncology Group

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Recommendations for the Treatment of Children With Acute Lymphoblastic Leukemia in the GFAOP
Actual Study Start Date : November 15, 2021
Estimated Primary Completion Date : September 1, 2028
Estimated Study Completion Date : September 1, 2030

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 .


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04794296


Contacts
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Contact: Ndella Ms DIOUF, MD 00(221)77 656 49 13. ndella.diouf@gfaop.org
Contact: BRENDA Ms MALLON, MSc 0033142115411 brenda.mallon@gustaveroussy.fr

Locations
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Côte D'Ivoire
CHU de Treichville à ABIDJAN Recruiting
Abidjan, Côte D'Ivoire
Contact: LINE COUITCHERE, DOCTOR       line.couitchere@gfaop.org   
Senegal
Hôpital Aristide Le Dantec, Avenue Pasteur, Recruiting
Dakar, Senegal, BP 3001
Contact: NDELLA DIOUF, DOCTOR       ndella61@hotmail.com   
Sponsors and Collaborators
French Africa Pediatric Oncology Group
Gustave Roussy, Cancer Campus, Grand Paris
More Information
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Responsible Party: French Africa Pediatric Oncology Group
ClinicalTrials.gov Identifier: NCT04794296    
Other Study ID Numbers: LAL-GFAOP2019
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases