Childhood ALLLALGFA2019NCT04794296
Recommendations for the Treatment of Children With Acute Lymphoblastic Leukemia in the GFAOP
An observational study of Childhood ALL, run by French Africa Pediatric Oncology Group at 3 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Childhood ALL
- How many people
- 500 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 15 Nov 2021to 31 Dec 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
Study population: 0 to 18 years of age presenting for treatment in any of the unit selected to carry out the recommandations
Who may be able to join
- Children 0 to 18 ALL first diagnosis No prior chemotherapy Cytology FAB L1 or L2
- -
Who cannot join
- ALL L3 (Burkitt) ALL previously treated with chemotherapy Trisomy 21
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Côte d’Ivoire1 site, 1 recruiting
- Recruiting
CHU de Treichville à ABIDJAN
Abidjan
LINE COUITCHERE, DOCTOR, line.couitchere@gfaop.org
Guinea1 site, 1 recruiting
- Recruiting
CHU Donka 030 BP 554
Conakry
Dr Aïssata BARRY, DR, 00(224)622300084, docteumama@gmail.com
Senegal1 site, 1 recruiting
- Recruiting
Hôpital Aristide Le Dantec, Avenue Pasteur,
Dakar, BP 3001
NDELLA DIOUF, DOCTOR, ndella61@hotmail.com
About this study
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:
- 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.
- Conditions
- Childhood ALL
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 ?
Measured: 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.
Measured: 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.
Measured: 5 weeks
Outcome
The vital status at the end of the first line of treatment.
Measured: 5 years
Secondary outcomes (1)
Survival without relapse of patients
the number of children in complete remission without relapse at the end of treatment .
Measured: first evaluation starts in 2026 so that enough time has elapsed to evaluate.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start15 Nov 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ALLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- French Africa Pediatric Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794296
- Sponsor's protocol ID
- LAL-GFAOP2019
- Acronym
- LALGFA2019
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2021
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recommendations for the Treatment of Children With Acute Lymphoblastic Leukemia in the GFAOP
- ClinicalTrials.gov ID
- NCT04794296
- Acronym / sponsor ID
- LALGFA2019 / LAL-GFAOP2019
- Conditions
- Childhood ALL
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- French Africa Pediatric Oncology GroupUniversity, hospital or other
- Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- 0 to 18 years of age presenting for treatment in any of the unit selected to carry out the recommandations
Key inclusion criteria (2 listed)
- Children 0 to 18 ALL first diagnosis No prior chemotherapy Cytology FAB L1 or L2
- -
Key exclusion criteria (1 listed)
- ALL L3 (Burkitt) ALL previously treated with chemotherapy Trisomy 21
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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 ?
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.
Ability to follow treatment:
Time frame: 5 weeks
The number of children who stop treatment without the consent of the doctor.
Outcome
Time frame: 5 years
The vital status at the end of the first line of treatment.
1 secondary outcome
Survival without relapse of patients
Time frame: first evaluation starts in 2026 so that enough time has elapsed to evaluate.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood ALL, run by French Africa Pediatric Oncology Group at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Côte d’Ivoire, Guinea, Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ndella Ms DIOUF, MD (00(221)77 656 49 13., ndella.diouf@gfaop.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.