NCT04425421

Brief Summary

This is the 4th LMB study by the French African Pediatric Oncology Group (GFAOP). The study hopes to be able to evaluate children earlier with stage I and II disease and to evaluate treatment response earlier so that the units can decide if a change in treatment is necessary, it is also hoped to provide an intensification of treatment for the stage IV disease.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
5 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Nov 2020Dec 2030

First Submitted

Initial submission to the registry

June 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

8.2 years

First QC Date

June 4, 2020

Last Update Submit

February 27, 2026

Conditions

Burkitt Lymphoma

Outcome Measures

Primary Outcomes (5)

  • Evaluation of the number of cases with local disease.

    evaluating the initial clinical reports and later histological reports to confirm the diagnosis and the stage.

    5 years

  • Evaluation of the number of cases by stage at the time of diagnosis.

    evaluating the initial clinical reports and later histological reports to confirm the stage and the diagnosis.

    5 Years

  • Evaluating the treatment given.

    Comparison of treatment given and recommended treatment.

    5 Years

  • Evaluating the follow up after treatment.

    How many children alive or dead after treatment

    5 Years

  • Number of relapse cases

    The evaluation and the treatment of relapse and outcome

    5 years

Secondary Outcomes (1)

  • Application of therapeutic recommendations

    5 years

Study Arms (1)

All children with Burkitt lymphoma and in 2 units the addition of Rituximab

An amendment has been added to give 4 injections during induction treatments as in the study in adults, that is to say 1 injection on D1 and D6 of each induction treatment, COPM or COPADM depending on the risk group in two centers. It is an amendment of the therapeutic recommendations "GFA LMB2019" which are the basis, the other centers will continue with this GFALMB2019 protocol as is

Other: OBSERVATIONAL

Interventions

OBSERVATIONALOTHER

OBSERVAITON OF THE CAPACITY OF THE GROUP TO TREAT ACCORDING TO THE PROTOCOLE AND LOOK AT OUTCOME FOR STAGE I AND II DISEASE

All children with Burkitt lymphoma and in 2 units the addition of Rituximab

Eligibility Criteria

AgeUp to 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All Children with a Burkitt's Lymhoma.

You may qualify if:

  • Clinical diagnosis of Burkitt's Lymphoma: all location. Diagnosis by cytology or histology. Not possible to follow all the treatment.

You may not qualify if:

  • Not a B Cell tumor. Child has been previously treated. Child has also another illness which would render the treatment incompatible. Parents refusal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hopital Yalgado Ouedraogo

Ouagadougou, 03 BP 7022, Burkina Faso

RECRUITING

CHU de Treichville à ABIDJAN

Abidjan, Côte d’Ivoire

RECRUITING

Cliniques Universitaires de Kinshasa

Kinshasa, Kinshasa City, BP 12 KIN XI, Democratic Republic of the Congo

RECRUITING

Cliniques Universitaires de Lubumbashi (CUL)

Lubumbashi, BP 1825, Democratic Republic of the Congo

RECRUITING

HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona

Antananarivo, BP 4150, Madagascar

RECRUITING

CHU Gabriel Touré (HGT)

Bamako, Mali

RECRUITING

Hôpital Aristide Le Dantec

Dakar, BP 3001, Senegal

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Central Study Contacts

Chantal Ms BOUDA, Dr.

CONTACT

00(226)70 10 01 30cgbouda@yahoo.fr

BRENDA MALLON, MSc PhD

CONTACT

0033142115411brenda.mallon@gustaveroussy.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2020

First Posted

June 11, 2020

Study Start

November 1, 2020

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2030

Last Updated

March 2, 2026

Record last verified: 2026-02

Locations

SE(1)DE(2)MA(1)BU(1)CÔ(1)