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

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.