AMADEUS
Research type
Research Study
Full title
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 or Myelodysplastic Syndromes as Maintenance after Allogeneic Haematopoietic Stem Cell Transplantation
IRAS ID
253607
Contact name
Birgit Whitman
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2018-001012-30
Clinicaltrials.gov Identifier
ERN_18-0323, Ethics self assessment number
Duration of Study in the UK
5 years, 11 months, 31 days
Research summary
Treatment options for older adults with Acute Myeloid Leukaemia (AML) and Myelodysplasia (MDS) are limited. Although stem cell transplantation remains one of the most effective treatments it is associated with severe side effects which have until recently prevented its use in older adults. In the last decade the use of reduced intensity transplants has allowed the extension of the potentially curative effect of transplantation to older patients in whom it was previously precluded. Although a major advance, such transplants are associated with a high risk of disease relapse particularly in patients with high risk disease.
This study will evaluate a new post-transplant treatment maintenance regimen given after a stem cell transplant with the aim of improving the outcome of patients with AML and high risk MDS.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
19/EM/0063
Date of REC Opinion
2 May 2019
REC opinion
Further Information Favourable Opinion