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

Clinical development

Targeted therapy
Immunotherapy

Clinical research (TRL 6-8)

The Clinical Investigation Center brings its expertise, technological platforms and network to the development of industrially sponsored trials, from first-in-man administration to multi-center phase III studies.

The support provided by the Clinical Investigation Center helps to improve the quality and safety of trials for patients and optimize access for sponsors. Through its national collaborations, the center fosters contacts for the expansion of studies across the country.

Description

Scope

Clinical research into AML, MPS, 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, MPS, MDS, ALL
Analysis laboratories: cytology, cytogenetics, immunophenotyping, molecular biology, immunomonitoring

Quality assurance

The Clinical Research and Innovation Department (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

ICT01-101 – EVICTION - A two-part, open-label, first-in-man clinical trial to evaluate the safety, tolerability and activity of intravenous doses of ICT01 as a single agent and in combination with a checkpoint inhibitor (ICI), in relapsed/refractory patients with advanced cancer, including leukemia.

Sponsor: Imcheck Therapeutics

CPX-351 TA-SMP - Phase II trial of CPX-351 monotherapy in acute leukemia secondary to myeloproliferative syndrome.

Sponsor: FILO

Partner: Jazz Pharmaceuticals

Terms

Clinical research project sponsored by industry
Partnership agreement with industrial partners to support study implementation

OPALE entity

CRCM / IPC (UMR-1068)

Contact

Other offers

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

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)