CLINICAL INVESTIGATION CENTER FOR THE SPONSORING AND CONDUCT OF PHASE I TO III INTERVENTIONAL CLINICAL TRIALS (ALL/AML/MPS/MDS)

Clinical development

Targeted therapy
Immunotherapy

Clinical research (TRL 6-8)

The Clinical Investigation Center conducts studies ranging from first-in-man administration to multicenter phase III trials, in collaboration with the FILO, GRAALL, GFM and FIM cooperative groups. Studies are sponsored by the Clinical Research and Innovation Department (DRCI).

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

Description

Scope

Clinical research in AML, SMP, MDS and ALL diseases, with the aim of improving patient care and quality of life:

Interventional research: early (phase I) and multi-center (phases II-III) clinical trials for new therapeutic approaches

Role

Operational coordination of clinical trials

Infrastructure

Operational investigation platform: project coordination, trial monitoring, regulatory management
Electronic case report forms (e-CRF)
Biobank: blood and bone marrow samples containing viable cells, nucleic acids and serum, from patients with AML, SMP, MDS, ALL
Analysis laboratories: cytology, cytogenetics, immunophenotyping, molecular biology, immunomonitoring

Quality assurance

DRCI has been ISO 9001 certified since 2013 (2008 and 2015 versions). The scope of this certification includes sponsoring and clinical investigation.

Specifications

Type of platform: Clinical investigation center with a CLIP²-certified early trial unit (PHOCEA)

Type of study: interventional clinical trials

Phases: I to III

Examples of partnerships

INA-03 - Open-label, first-in-man, dose-escalation study of intravenous INA03 in adult patients with relapsed/refractory acute leukemia.

Partner: INATHERYS

Terms

Clinical research project initiated and sponsored by the clinical investigation center
Partnership agreement with the manufacturers concerned to support the conduct of the study

OPALE entity

CRCM / IPC (UMR-1068)

Contact

Other offers

CLINICAL INVESTIGATION CENTER FOR THE COORDINATION AND CONDUCT OF PHASE I TO III CLINICAL TRIALS IN LEUKEMIA AND RELATED DISEASES (AML, MPS, MDS, ALL)

PLATFORM FOR DEVELOPING AND IMPLEMENTING TESTS FOR PRECLINICAL VALIDATION IN VITRO, EX VIVO, AND IN VIVO (ACUTE LEUKEMIA)

PLATFORM FOR ACCELERATING THE DISCOVERY AND OPTIMIZATION OF NEW BIOACTIVE MOLECULES (ACUTE LEUKEMIA)