NATIONAL CLINICAL RESEARCH NETWORK FOR THE DESIGN, SPONSORING AND CONDUCT OF PHASE I-IV INTERVENTIONAL AND NON-INTERVENTIONAL CLINICAL TRIALS (CLL/WM/AML/MPS)

Clinical development

CLL
Waldenström's macroglobulinemia
AML
MPS

Targeted therapy
Cell therapy
Immunotherapy
Chemotherapy

Clinical research (TRL 6-8)

FILO sponsors national multicenter clinical trials in hematology: acute myeloid leukemia (AML), myelofibrosis, essential thrombocythemia (in collaboration with the France Intergroupe des syndromes Myéloprolifératifs - FIM), chronic lymphocytic leukemia (CLL) and Waldenström macroglobulinemia (WM). FILO members represent all French and Belgian specialists involved in the study of these diseases (apart from members of the Acute Leukemia French Association - ALFA).

Focused on improving care and its benefits, independent (i.e. academically sponsored) clinical studies are of key importance in optimizing the efficacy, safety and cost/benefit ratio of healthcare. Conducted at the initiative of FILO members, these investigations aim to provide the best treatment option for a given patient (or group of patients).

Description

Scope

Clinical research in AML, CLL and WM pathologies, with the aim of improving patient care and quality of life:

Interventional research: multicenter clinical trials for new therapeutic approaches
Non-interventional research: retrospective or prospective studies based on real-life observatory data, to assess the efficacy and safety of treatments

Role

Clinical trial sponsor
Operational coordination of clinical trials

Investigation centers

80 investigator centers in France (80 specialized in CLL-MW and 35 specialized in AML)

Infrastructure

Operational investigation platform: project coordination, trial monitoring, regulatory management
Electronic case report forms (eCRF)
FILOTHEQUE: ISO 20 387-certified biobank. Centralized sampling and preparation of plasma, serum, cells, DNA, RNA and cDNA samples, in compliance with clinical trial specifications, regulatory requirements and standards
Centralized analysis laboratories (CLL): highly sensitive MRD, karyotyping, FISH reading

Quality assurance

Standard Operating Procedures (SOPs)
Coordination unit
Network of regional clinical research associates (CRAs) for quality control and assistance to major recruitment centers

Specifications

Type of platform: national multicenter network

Type of studies: interventional and non-interventional clinical trials

Phases: I to IV

Examples of partnerships

ERADIC : Evaluation of Risk-Adapted and MRD-Driven Strategy for Untreated Fit Patients With Intermediate Risk Chronic Lymphocytic Leukemia - The aim of this study is to test the potential benefit of an innovative combination of targeted therapy over the standard the immunochemotherapy (FCR).

Partners: AbbVie, Janssen-Cilag

LAMSA2020-VENCOSA : A phase II randomized study to assess the efficacy on outcome of Venetoclax combined with Cytarabine versus Idarubicin combined with Cytarabine administered as post-remission therapy to elderly patients with acute myeloid leukemia in first remission - The primary objective of this trial is to compare the Relapse free survival (RFS) at 2 years after follow-up between the two arms: Venetoclax with Cytarabine versus Idarubicin with Cytarabine.

Partner: AbbVie

ELEGANCE : A non-interventional ambispective real-world cohort of rEfractory and reLapsed FLT3 mutated Acute MyEloid Leukemia patients treated with Gilteritinib in FrANCE – The aim of the study is to describe gilteritinib effectiveness in FLT3-mutated AML patients in R/R situation treated in the context of early access program to gilteritinib in France through Temporary Authorisation of Use, the so-called ATU program, and the post ATU period from marketing authorisation to launch when reimbursement and price are published..

Partner: Astellas

FOLLOW : French Observational study of patients with chronic Lymphocytic Leukemia Or small lymphocytic lymphoma in real-World settings – The aim of the study is to set a prospective cohort of real-world CLL/SLL patients with symptomatic disease in order to evaluate medical practices and their change and representativity over time.

Partners : Abbvie, AtsraZeneca, Beigene, Janssen-Cilag,

Terms

Clinical research project initiated and sponsored by FILO
Partnership agreement with the manufacturers concerned to support the trial or study

OPALE entity

French Innovative Leukemia Organization (FILO)

Contact

Other offers

NATIONAL CLINICAL RESEARCH NETWORK FOR THE DESIGN, SPONSORING AND CONDUCT OF PHASE I-IV INTERVENTIONAL AND NON-INTERVENTIONAL CLINICAL TRIALS - COLLABORATION (CLL/WM/AML/MPS)

PHASE I-IV INTERVENTIONAL AND NON-INTERVENTIONAL CLINICAL TRIAL DATABASES (MPN/CLL/WM/AML)

HEMATOLOGICAL MALIGNANCIES BIOBANK (CLL/AML)