NATIONAL CLINICAL RESEARCH NETWORK FOR THE DESIGN AND CONDUCT OF PHASE I-IV INTERVENTIONAL AND NON-INTERVENTIONAL CLINICAL TRIALS IN CHILDHOOD AND ADOLESCENT LEUKEMIA (AML/ALL/MPS/MDS)

Clinical development

Targeted therapy
Cell therapy
Immunotherapy
Hematopoietic stem cell transplant
Chemotherapy

Clinical research (TRL 6-8)

The Société Française de lutte contre les cancers et les leucémies de l'Enfant et de l'adolescent (SFCE) is the leading partner for coordinating care and research into childhood cancers at national level. Together with the various players in pediatric oncology and hematology, it contributes to improving France's attractiveness in terms of clinical and translational research. SFCE centers are involved in the design and conduct of international clinical trials, helping to increase enrolment and bring new treatments to young patients. The SFCE Leukemia Committee coordinates the 28 clinical centers that treat acute leukemia, in liaison with biologists and researchers. It encourages the emergence of clinical and translational research projects, which are approved by the SFCE Scientific Advisory Board.

The SFCE is an association of healthcare professionals (surgeons, pediatric oncologists and hematologists, radiotherapists, radiologists, pathologists, biologists, nurses, researchers, psychologists). It has over 500 members (clinicians, researchers, engineers and clinical research technicians), spread across 30 clinical centers accredited by the French Cancer Institute (INCa) to care for children and adolescents with cancer and leukemia.

Description

Scope

The SFCE Leukemia Committee is divided into five subgroups:

1st-line ALL: divided into 3 subsections: ALL, Ph1 ALL and ALL < 1 year
2nd-line ALL
AML
Myeloproliferative syndromes (MPS)
JMML and MDS

Role

A large number of clinical trials (www.u-link.eu) have been designed and conducted by SFCE members. Expert centers play an active role in enrolling patients in phase 1 to 4 trials. For leukemia and related diseases, clinical research protocols are discussed by the Leukemia Committee. The committee works closely with national, European and international research structures, in particular by actively participating in discussions on protocols for the care of children with leukemia.

One or more representatives for international relations is/are appointed within the sub-committees and/or at the suggestion of the Board to facilitate this collaboration. Among the objectives of the SFCE Leukemia Committee:

To design and activate therapeutic trials in all areas of comprehensive management of the various leukemias at national and international level, and to participate in international clinical research efforts.
To design and coordinate phase I-II studies to evaluate innovative treatments, in close collaboration with the SFCE's "new drugs" group, the pediatric INCa-certified early-phase centers (CLIPP) and the European "Innovative Therapies in Childhood Cancer" (ITCC) group.
To develop biological studies in various pathologies.
To interact with other national and international groups involved in the management of these pathologies.

Investigation centers

30 expert centers
Operational clinical research teams from the 30 centers meet annually, coordinated by the SFCE, to discuss the conduct of protocols in the centers

Infrastructure

National pediatric AML database (DOREMy), in conjunction with the CONECT-AML consortium (www.conect-aml.fr) : harmonized clinical and biological databases for integrated research into the management of pediatric acute myeloid leukemia.

Specifications

Type of platform: national multicenter network

Type of studies: interventional and non-interventional clinical studies

Phases: I to IV

Examples of partnerships

ALARM project - The ALARM3 project comprises 3 work packages (WP). WP2 aims to compare the sensitivity of leukemia cells to a panel of drugs at initial diagnosis and relapse, using ex vivo drug testing. A specific study is being carried out on Vyxeos.

Partner: Jazz Pharmaceutical

Terms

Clinical research project initiated and sponsored by an SFCE member
Partnership agreement between the SFCE member and the industry concerned to support the trial or study

OPALE entity

SFCE

Contact