NATIONAL CLINICAL RESEARCH NETWORK FOR THE DESIGN, SPONSORING AND CONDUCT OF PHASE I TO III INTERVENTIONAL AND NON-INTERVENTIONAL CLINICAL TRIALS (MDS)

Clinical development

Targeted therapy
Cell therapy
Immunotherapy
Chemotherapy

Clinical research (TRL 6-8)

The GFM sponsors multicenter clinical trials in hematology: myelodysplastic syndromes (MDS). The GFM brings together specialists from France, Europe and other French-speaking countries involved in the study of MDS.

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 GFM members, these investigations aim to provide the best treatment option for a given patient (or group of patients).

Description

Scope

Clinical research into myelodysplastic syndromes, 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 promoter
Operational coordination of clinical trials

Investigation centers

65 investigator centers in France.

Infrastructure

Project coordination, regulatory management, trial monitoring, administrative management.

Operational team
Promotional team
Coordinators
Monitors

Quality assurance

Quality assurance procedures developed by GFM for the promotion of clinical studies.

Specifications

Type of platform: national and European multicenter network

Type of studies: interventional and non-interventional clinical trials

Phase: I to III

Examples of partnerships

COMBOLA Trial - A randomized phase I/ II multicenter study evaluating combination of luspatercept in LR-MDS without RS having failed or being ineligible to ESA.

Partner: BMS

AVENHIR trial - Phase II study with safety run-in of Azacitidine (AZA) combined with Venetoclax (VEN) in patients with higher-risk Chronic Myelomonocytic Leukemia (CMML).

Partner: ABBVIE

GFM-ONUVEN-MDS - A phase I/II, open-label, single arm, multicenter dose-finding study to assess the safety and preliminary efficacy of Oral Azacitidine CC-486 (ONUREG®) in combination with Venetoclax (VENCLYXTO®) in previously untreated higher-risk myelodysplastic syndromes ineligible for allogenic transplantation.

Partners: ABBVIE, Bristol-Myers Squibb (BMS)

GFM-DACORAL-DLI - A phase II prospective study: ASTX727 and donor lymphocyte infusions (DLI) after allogeneic stem cell transplantation (ALLO SCT) in very high-risk MDS or AML patients.

Partners: ASTEX, SANOFI