CClinicalTrials.gg
RecruitingNCT04794296LALGFA2019Updated Mar 2, 2026

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

An observational study in Childhood ALL, sponsored by French Africa Pediatric Oncology Group. Recruiting at 3 sites in 3 countries. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-02.

Sponsored by French Africa Pediatric Oncology Group · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
Up to 18 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

03

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
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

Inclusion criteria

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

-

Exclusion criteria

Exclusion Criteria:

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

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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 ?

    Time frame: 5 weeks

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

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

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

  4. Ability to follow treatment:

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

    Time frame: 5 weeks

  5. Outcome

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

    Time frame: 5 years

Secondary outcomes

  1. Survival without relapse of patients

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

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

06

Study locations

3 of 3 sites recruiting
  • 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
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04794296
Lead sponsor
French Africa Pediatric Oncology Group
Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Responsible party
Sponsor
First posted
Mar 12, 2021
Start date
Nov 15, 2021
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Mar 2, 2026

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion