CLINICAL TRIALS CENTER FOR THE DESIGN, SPONSORING AND CONDUCT OF PHASE I TO IV INTERVENTIONAL AND NON-INTERVENTIONAL CLINICAL TRIALS IN LEUKEMIA (CML, AML, ALL)
- Clinical development
- ALL
- Targeted therapy
- Alternative therapy
- Precision medicine
- Clinical research (TRL 6-8)
The Centre Hospitalier de Versailles sponsors multicenter clinical trials in hematology for Chronic Myeloid Leukemia (CML), Acute Myeloblastic Leukemia (AML) and Lymphoblastic Leukemia.
Focused on improving care and its benefits, independent clinical trials (i.e. academically sponsored) are of key importance in optimizing the efficacy, safety and cost/benefit ratio of healthcare. Conducted at the initiative of the Centre Hospitalier de Versailles and in collaboration with industrial and academic partners, these investigations aim to provide the best treatment option for a given patient (or group of patients). The structure's responsiveness is an asset in reducing administrative processing times. Our experience enables us to conduct national and international studies. DRCI department (Direction de la Recherche Clinique et de l’Innovation) also works closely with patient associations.
Description
Scope of research activities
Clinical research in pathologies with the aim of improving patient care and quality of life:
- Interventional research: multicenter clinical trials for new therapeutic approaches
- Precision medicine with pragmatic trials and observatories
Role
- Clinical trial sponsor
- Operational coordination of clinical trials
Investigation centers
The number of investigator centers involved in sponsored studies ranges from 5 to over 60, depending on the scope of the study. Most studies are based on existing collaborative structures (ALFA, GRAALL, EWALL, FiLMC).
Infrastructure
- Sponsoring unit
- Investigation unit
- Quality unit
- Pharmacovigilance unit
- Data and data protection units
- Electronic Case Report Forms (eCRF)
- Analysis laboratories
- ALL TARGET OBS observatory databases (Centre Hospitalier de Versailles) - An observatory of patients treated for relapsed/refractory T-cell acute lymphoblastic leukemia with oncogenetic characterization. The first observatory to implement precision medicine in hematology
Quality assurance
- Standard Operating Procedures (SOP)
- Sponsoring unit
- Investigation unit
Specifications
The platform
The Clinical Research Center (Centre Hospitalier de Versailles) includes a Sponsoring Unit, which manages trials initiated by the Versailles Hospital teams. An Investigation Unit oversees the setting up and monitoring of the studies.
Type of study: interventional clinical trials, Research Involving the Human Person (RIPH) 1 to 5
Phases: II to III
Examples of partnerships
A combination of ponatinib and 5-azacitidine in chronic myelogenous leukaemia in accelerated phase or in myeloid blast crisis (PONAZA) – This project is aiming to improve the survival of patients with chronic myelogenous leukemia in advanced phase and myeloid blast crisis. The basis of this strategy is to add the demethylating agent 5-Azacitidine to the tyrosine kinase inhibitor ponatinib and evaluate its activity in 2 cohorts of patients with either chronic myelogenous leukemia in advanced phase or myeloid blast crisis.
Partner: Incyte
Therapies in combination or sequentially with tyrosine kinase inhibitors (TKIS) in chronic phase chronic myelogenous leukemia patients in ccr (ACTIW) – This study aims to select, according to an adaptive plan, molecules of interest capable of inducing the deep molecular response of patients with CML (MR4.5) by targeting quiescent stem cells .
Partner: Pfizer
Philadelphia positive B-cell ALL. EWALLPH-03-study – European study. An open label, 3-arm, Randomised phase II study to Compare the Safety and Efficacy of Ponatinib in combination with either Chemotherapy or Blinatumomab with Imatinib plus Chemotherapy as front-line therapy for patients aged 55 years and over with Philadelphia chromosome positive (Ph+ or BCR-ABL+) acute lymphoblastic leukemia (ALL).
Partner: Incyte
B-cell ALL in the elderly. EWALL-INO study – European study. A Phase 2 Study of Inotuzumab Ozogamicin (INO) Combined to Chemotherapy in Older Patients with Philadelphia Chromosome-negative CD22+ B-cell Precursor Acute Lymphoblastic Leukemia - EWALL INO.
Partner: Pfizer
Terms
- Clinical research project initiated and sponsored by the Centre Hospitalier de Versailles
- Partnership agreement with the manufacturers involved to support the study
OPALE entity
IDMIT (UMR-1184)
Team leader
Contact
Dr. Sandrine PalcyBusiness Development Director