NATIONAL CLINICAL RESEARCH NETWORK FOR THE DESIGN, SPONSORING AND CONDUCT OF PHASE II TO IV INTERVENTIONAL AND NON-INTERVENTIONAL CLINICAL TRIALS (ALL)

Clinical development

Cell therapy
Immunotherapy

Clinical research (TRL 6-8)

The GRAALL intergroup initiates multicenter clinical trials in Belgium, Switzerland and France in the field of acute lymphoblastic leukemia (ALL) in adults. It is a multidisciplinary clinical and translational research network, operating through shared operational centers. GRAALL members represent 79 clinical centers, including 60 in France, 9 in Belgium and 10 in Switzerland.

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

Description

Scope

Clinical research in adult ALL pathology, 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

79 investigator centers: 60 in France, 9 in Belgium and 10 in Switzerland.

Infrastructure

Central coordination office (Lyon)
Centralized molecular biology laboratory
- B-ALL (Paris Saint-Louis)
- T-ALL (Paris Necker)
Centralized IG/TR MRD network
- Brussels
- Lille
- Paris, Necker & Saint-Louis
- Rennes
- Toulouse
- Zurich
Independent data center & biostatistical unit (Paris Saint-Louis)

Quality assurance

Standard Operating Procedures (SOPs)
Coordination unit

Specifications

Type of platform: transnational multicenter network

Type of studies: interventional and non-interventional clinical trials

Phases: II to IV

Examples of partnerships

Efficacy and toxicity of Blinatumomab in the French ATU for adult BCP-ALL R/R, or with MRD+ (FRENCH-CYTO) (FRENCH-CYTO) – This study aimed at discovering the determinantes of the response to Blinatumomab based on a real-word data analysis of the compassionate use program in France.

Partner: Amgen

Multicenter protocol for the treatment of Acute Lymphoblastic Leukemia (ALL) in young adults (18-59 years old) PROTOCOL GRAALL-2014 - The purpose of this protocol is to improve the outcome of Adult frontline ALL through the incorporation of new chemotherapy (Nelarabine), immunotherapy (Blinatumomab) and targeted therapy (Nilotinib).

Partners: Amgen, Novartis, Sandoz