NATIONAL CLINICAL RESEARCH NETWORK FOR THE DESIGN, SPONSORING AND CONDUCT OF PHASE I-IV INTERVENTIONAL AND NON-INTERVENTIONAL CLINICAL TRIALS (AML)
- Clinical development
- AML
- Targeted therapy
- Cell therapy
- Immunotherapy
- Hematopoietic stem cell transplant
- Chemotherapy
- Clinical research (TRL 3-8)
Within the current regulatory framework, ALFA sponsors national multicenter clinical trials in the field of acute myeloid leukemia (AML) in adults. Comprising clinicians, biologists and clinical research assistants, the group has a network of centralized operational structures and interfaces with translational research laboratories.
Focused on improving care and its benefits, academically sponsored independent clinical trials (IIT, investigator initiated trial; IST, investigator sponsored trial) are of key importance in optimizing the efficacy, safety and cost/benefit ratio of healthcare. Conducted at the initiative of ALFA members, these studies aim to provide the best treatment option for a given patient (or group of patients).
Description
Scope
Clinical research on AML, with the aim of improving patient care and quality of life:
- Interventional research: clinical trials testing new therapeutic approaches, usually oligo- or multi-centric for ALFA, but could possibly be uni-centric
- Non-interventional research: studies based on real-life observatory data, to assess the efficacy and safety of approved treatments, but also to identify prognostic biomarkers; ALFA favors prospective observational studies
Role
- Clinical trial/study sponsor
- Operational coordination of clinical studies, including modern, centralized somatic genomics and residual detectable disease (MRD) monitoring
Investigation centers
33 investigative centers in mainland France and on Reunion Island
Organization
- Dr. Renaud Buffet, Medical coordination
- Prof. Raphaêl Itzykson, President of the Scientific Council
Infrastructure
- Centralized review of conventional cytogenetic results
- Centralized molecular biology laboratory (somatic genomics, molecular MRD)
- Network of laboratories monitoring residual disease by flow cytometry (FMC)
- Centralized biobank
- Data Center and independent Biostatistics unit
- Network of translational research laboratories linked to ALFA.
Quality assurance
- Standard Operating Procedures (SOPs)
- Coordination unit
Specifications
Type of platform: national multicenter network
Type of studies: prospective interventional or non-interventional clinical studies within the current European regulatory framework
Phases: I to IV
Examples of partnerships
Prospective non-interventional study documenting the management and outcome of adult patients with AML (ALFA-PPP observational cohort) - Prospective collection of all initial and follow-up clinico-biological data from adult patients with newly diagnosed or relapsed/refractory AML, treated according to options approved by the health authorities, including early access to new drugs.
Partners: Astellas, BMS-Celgene, Servier
Terms
- Clinical research project initiated and sponsored by ALFA
- Partnership agreement with the concerned manufacturers to support the study (supply of study drugs and financial support).
OPALE entity
Acute Leukemia French Association (ALFA)
Head of Entity
Contact
Dr. Sandrine PalcyBusiness Development Director