DATA AND SAMPLES FROM ADULT PATIENTS WITH ACUTE MYELOID LEUKEMIA (AML)
- Collections
- Database
- AML
- Targeted therapy
- Cell therapy
- Immunotherapy
- Hematopoietic stem cell transplant
- Clinical research (TRL 6-8)
Access to the ALFA group's databases and sample collections for clinical-biological studies of cohorts of adult patients with acute myeloid leukemia (AML) at all stages of the disease, at diagnosis and under treatment (response to treatment, relapse, follow-up).
Comprehensive clinico-biological data from patients included in clinical trials, combined with qualified blood and bone marrow samples. Benefit from homogeneously treated patient data/samples. Access to individual longitudinal follow-up (diagnosis/remission/relapse).
Description
Scope
Samples and sets of clinico-biological data monitored as part of therapeutic protocols, enabling projects to be carried out in the field of AML:
- Clinico-biological control cohorts (external control arms)
- Highly qualified and annotated biological samples
- Translational studies in collaboration with the network's translational platforms
Provision of anonymized data sets and/or samples
- Submission of application to ALFA
- Review by ALFA's Scientific Council
- Approval by ALFA Board of Directors
- Contractualization with OPALE's legal and partnerships manager
Organization
- Dr. Renaud Buffet, Medical Coordinator
- Prof. Raphaêl Itzykson, President of the Scientific Council
Infrastructure
- Database hosting on secure servers
- Project managers and clinical research assistants
Quality assurance
The quality assurance procedures used to build up collections and gather data around them comply with current legislation. In particular, they ensure:
- Patient information and consent to the use of biological samples for research purposes
- Compliance with data retention periods
- Data security and confidentiality throughout the chain, from consent to storage of the material and all associated data
Specifications
Collections
Annotated collections of nucleic acids (DNA and RNA, samples from several thousand patients), cells (leukemic blasts, non-leukemic mononuclear cells), serum or plasma.
Samples collected at initial diagnosis, in remission phase and at diagnosis of refractory state or relapse.
Data sets:
- Relevant patient medical history
- Biological characteristics of the disease, including its somatic mutational landscape described according to the current best standards (ELN 2022)
- Documentation of first-line treatment (including, when performed, information on allogeneic transplantation). Documentation of refractory status and possible relapses, monitoring of residual disease by molecular biology, and, less systematically, residual disease by flow cytometry.
- Documentation of disease response, or refractory state, residual disease (MRD), remission, possible relapses (dates, lines of treatment), date and cause of possible death
Type of study: interventional and non-interventional clinical studies
Phases: I-IV
Examples of partnerships
An ALFA 2101 Multicenter Randomized Phase II Study: CPX-351 Versus Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics (ALFA2101) -The trial is a randomized, open-label phase II study comparing CPX-351 vs conventional intensive chemotherapy in patients with newly diagnosed de novo AML and intermediate- or adverse-risk genetics (according to 2017 ELN criteria).
Partner: Jazz pharmaceutical
A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD Relapse/Refractory (R/R) AML (AGORA-1) - This is a national, open-label, single-arm, multicenter phase II trial evaluating the safety and efficacy of adding gilteritinib, a new FLT3 inhibitor to the AGORA platform, consisting of the combination of an intermediate dose of cytarabine and a divided dose of GO in adult patients with R / R AML with an FLT3-ITD mutation."
Partners: Astellas, Pfizer
Terms
- Research project approved by the ALFA Board of Directors
- Provision of samples - Biological Material Transfer Agreement
- Provision of data sets - Licensing agreement
OPALE entity
Acute Leukemia French Association (ALFA)
Head of Entity
Contact
Dr. Sandrine PalcyBusiness Development Director
Other offers
NATIONAL CLINICAL RESEARCH NETWORK FOR THE DESIGN, SPONSORING AND CONDUCT OF PHASE I-IV INTERVENTIONAL AND NON-INTERVENTIONAL CLINICAL TRIALS (AML)
NATIONAL CLINICAL RESEARCH NETWORK TO SUPPORT SPONSORS OF PHASE I TO IV INTERVENTIONAL AND NON-INTERVENTIONAL CLINICAL TRIALS (AML)
NATIONAL CLINICAL RESEARCH NETWORK TO SUPPORT DRUG RESEARCH AND DEVELOPMENT (AML)