AMADEUS

AMADEUS: A Double-blind, Phase III, Randomised Study to Compare the Efficacy and Safety of Oral Azacitidine (CC-486) Versus Placebo in Subjects with Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndromes (MDS) as Maintenance after Allogeneic Haematopoietic Stem Cell Transplantation

The information below is intended for medical professionals.  For patient information please click here and here

Study design/summary:  This is a prospective, two arm, double-blind, phase III international clinical trial in adult patients with AML and MDS who have undergone an allogeneic stem cell transplant (allo-SCT) and are randomised to receive oral azacitidine or placebo upon engraftment until 12 months post-transplant.

Objectives:

  • The primary objective is to compare relapse free survival (RFS) of patients with AML or high risk MDS treated with maintenance therapy of oral azacitidine versus placebo post allo-SCT.
  • The secondary objectives are to compare overall survival (OS), cumulative incidence of relapse (CIR), non-relapse mortality (NRM), incidence of acute and chronic graft-versus-host-disease (GVHD), time to treatment discontinuation with oral azacitidine compared with placebo, safety, quality of life (QoL) and GVHD-free and relapse-free survival (GRFS).

Centres:  22 IMPACT centres

Target Number of patients:  324 patients will be randomised to the AMADEUS trial across IMPACT centres.

Patient population:  Patients with a diagnosis of AML or high risk MDS who have undergone an allo-SCT using a myeloablative conditioning (MAC) or reduced intensity conditioning (RIC) regimen will be eligible.

Sponsorship/Funding:  University of Birmingham, funded by the IMPACT network

Trial Status:  Open to recruitment

Start Date:  14 June 2019

Duration5 years.  Patients will be recruited over a three year period.  Patients will be followed up for a minimum of two years from randomisation.

Trial Contacts:  AMADEUS@trials.bham.ac.uk

If you are a patient and interested in taking part in a clinical trial, please speak with your consultant who will be able to offer you further information and discuss whether it is suitable for you.  A referral from your medical team would be required in order to consider you for treatment on a clinical trial.