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AMADEUS

Aim of the trial:

To see if taking the chemotherapy drug Azacitidine reduces the chance of acute myeloid leukaemia (AML) or high-risk myelodysplastic syndromes (MDS) coming back after a stem cell transplant.

Why is the trial important?

A stem cell transplant can result in long-term survival for many patients. Unfortunately, sometimes the original leukaemia comes back, which is known as relapse. This is why clinicians are looking for ways to improve a type of treatment called maintenance therapy that prevents relapse after transplant.

Azacitidine is a chemotherapy drug that is already given as a treatment to patients with AML or MDS who cannot have a stem cell transplant. There is now evidence to suggest that Azacitidine could also reduce the chance of the blood cancer returning after transplant. This treatment now needs to be tested on more patients to see if the benefit is great enough for Azacitidine to be given to all MDS and AML patients post-transplant.

Who can take part?

Patients over 16 who have received an allogenic stem cell transplant to treat either AML or high risk MDS.

What will happen to me?

This is a randomised trial, which means patients will be placed into one of two treatment groups by a computer. Very soon after transplant, when the donor’s cells have engrafted, one group will receive Azacitidine and the other will receive a dummy drug, also known as a ‘placebo’. This will continue for a maximum of twelve months. While the trial is underway neither yourself nor your doctor will know which group you have been put into. This is known as a ‘double-blind’ trial.

Throughout the trial both groups will continue to receive the standard treatments they would normally be given during their recovery. During this time, you will be asked to undergo clinical check-ups and complete questionnaires to see how well the treatment is working.  

How will we know if the trial is successful?

The trial will compare the number of patients taking Azacitidine that remain relapse-free compared to those taking the placebo treatment. It will also document other complications such as how often side-effects like GvHD occur and how the treatment impacts the patient’s quality of life.

Stage: Phase 3

Study lead: Professor Charles Craddock

Recruiting: 324 patients by June 2022

Study length: Five years from June 2019

Information published: 03/09/20
Next review due: 03/09/23

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