NATIONAL CLINICAL RESEARCH NETWORK FOR THE DESIGN, SPONSORING AND CONDUCT OF PHASE I-IV INTERVENTIONAL AND NON-INTERVENTIONAL CLINICAL TRIALS

Clinical development

CLL
Waldenström's macroglobulinemia
AML
MPS

Targeted therapy
Cell therapy
Immunotherapy
Chemotherapy

Clinical research (TRL 6-8)

FILO brings its expertise, technological platforms and network to the development of academically-sponsored hematology clinical trials on a national or international scale: acute myeloid leukemia (AML), myelofibrosis, essential thrombocythemia (in collaboration with FIM), chronic lymphocytic leukemia (CLL) and Waldenström's 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 trials are of key importance in optimizing the efficacy, safety and cost/benefit ratio of healthcare. Conducted at the initiative of academic organizations, these investigations aim to provide the best treatment option for a given patient (or group of patients).

Description

Scope

Clinical research for AML, myelofibrosis, essential thrombocythemia, 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

Investigator-coordinator of clinical trials

And/or

Operational coordination of 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 (LLC): highly sensitive MRD, karyotyping, FISH reading

Quality assurance

Standard Operating Procedures (SOPs)
Coordination unit,
Network of regional clinical research associates (CRAs) for quality control

Specifications

Type of platform: national multicenter network

Type of studies: interventional and non-interventional clinical trials

Phases: I to IV

Examples of partnerships

BIG-1 : Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR (BIG-1) - This open label, multicenter phase II/III study with multiple randomization phases at different stages of AML treatment (induction, consolidation and HSCT where applicable) is designed to improve OS in younger (18 to 60 year-old) patients, with AML risk-adapted patient strategies."

Sponsor: CHU Angers

LLC2007SA : Single-agent rituximab as maintenance treatment versus observation after combined induction immunochemotherapy with fludarabine, cyclophosphamide and rituximab (FCR) in patients older than 65 years with previously untreated B-cell chronic lymphocytic leukemia (B-CLL): a phase III intergroup trial of the GOELAMS1 and the FCGCLL/WM2 groups – The aim of the study was to demonstrate superiority in 3-year progression-free survival, (in the intent-to-treat, from randomization) of rituximab maintenance over observation in patients in Complete or Partial Response after induction by FCR.

Sponsor: CHU Tours

Partner : ROCHE

ECWM-1 : Efficacy of first line Dexamethasone, Rituximab and Cyclophosphamide (DRC) +/- Bortezomib for patients with Waldenström’s Macroglobulinemia. A multicenter open label two-arm randomized european phase III study -The aim of the study is to test whether the efficacy of the well tolerated DRC regime can be further improved by adding Bortezomib.

Sponsor: University Hospital Ulm, Germany (represented in France by CH Lens)

CLL6-RESIDUUM : An Australasian and French, Phase III, Multicentre, Randomised Trial Comparing Lenalidomide Consolidation Vs No Consolidation in Patients With Chronic Lymphocytic Leukemia and Residual Disease Following Induction Chemotherapy - The primary objective is to investigate if lenalidomide consolidation is capable of extending progression free survival in previously untreated or minimally treated CLL patients with residual disease after chemotherapy

Sponsor: Australasian Leukaemia and Lymphoma Group (ALLG) (represented in France by FILO)

Terms

Clinical research project with national or international academic promotion
Partnership agreement with industrial partners to support the 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 (CLL/WM/AML/MPS)

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

HEMATOLOGICAL MALIGNANCIES BIOBANK (CLL/AML)

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)