• Clinical development
  • AML
  • Targeted therapy
  • Cell therapy
  • Immunotherapy
  • Hematopoietic stem cell transplant
  • Clinical research (TRL 6-8)

ALFA brings its expertise and network of specialists and recruitment centers to bear on clinical trials and studies of innovative treatments for acute myeloid leukemia (AML) in adults.

The support of the ALFA national network optimizes access to centers for sponsors and contributes to improving the quality and safety of trials. Its internationally recognized laboratories (somatic genomics, MRD monitoring, translational platforms) can provide centralized assessment of certain key elements of the protocol.  Finally, through its international collaborations, ALFA can facilitate contacts for extending trials or studies to other regions of the world.

Description

Scope 

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

  • Interventional research: clinical trials testing new therapeutic approaches
  • Non-interventional research: studies based on real-life observation data, to assess the efficacy and safety of approved treatments

Role

  • Support in designing a clinical trial/study protocol 
  • Recommendations on the choice and number of centers participating in the study 
  • Recommendations of experts (Key Opinion Leader) for the study's steering committee or independent data safety monitoring board
  • Assumption of tasks delegated by the sponsor in the operational conduct of the study/trial, including characterization and centralized biological monitoring of the disease
  • Conduct of correlative biological studies with translational laboratories linked to the ALFA group

Investigation centers

33 investigating centers in mainland France and Reunion Island

Organization

  • Dr. Renaud Buffet, Medical Coordinator
  • 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 the ALFA group

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

Efficacy of oral azacitidine plus best supportive care as maintenance therapy in subject with AML in complete remission (QUAZAR AML-001) - AH. Wei et al. N Engl J Med. 2020;383:2526-2537 - This study enrolled 472 participants, aged 55 or older, with a diagnosis of de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML), and who have achieved first complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) following induction with or without consolidation chemotherapy.

Partner: BMS-Celgene

Efficacy study of anti-KIR monoclonal antibody as maintenance treatment in AML (EFFIKIR) - N. Vey et al. Annual ASH Meeting, 2017 (abstract) - Double-Blind Placebo-Controlled Randomized Phase 2 Study evaluating the efficacy of lirilumab (IPH2102/BMS-986015) as Maintenance Treatment administered in elderly patients with Acute Myeloid Leukemia (AML) in first complete remission.

Partner: Innate-Pharma

Terms

  • Clinical research project promoted by industry
  • Partnership agreement with industrial partners to support study coordination

OPALE entity

Acute Leukemia French Association (ALFA)

Acute Leukemia French Association (ALFA)
Hervé Dombret
Prof. Hervé Dombret
Head of Entity

Contact

Sandrine Palcy Dr. Sandrine Palcy
Business Development Director

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