CompletedPhase 3

Randomised Study of Oral Azacitidine vs Placebo Maintenance in AML or MDS Patients After Allo-SCT

United Kingdom326 participantsStarted 2019-06-14

Plain-language summary

This study will evaluate a new maintenance therapy with the aim of improving the outcome of patients with acute myeloid leukaemia (AML) and myelodysplasia (MDS) after stem cell transplantation.

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥ 16 at the time of signing the informed consent form
. Patients with a diagnosis of any of the below:
. At the time of allo-SCT
. Able to commence therapy between 42 to 84 days following allo-SCT
. Post-transplant bone marrow
. AML patients - blast count ≤ 5% confirmed within 28 days prior to starting study therapy
. MDS patients - confirmation of CR post-transplant with blast count ≤ 5% in bone marrow
. Adequate neutrophil and platelet engraftment within 14 days prior to starting study therapy defined as:

Exclusion criteria

. Use of any of the following after transplantation and prior to starting study therapy:
. Subjects who have undergone a haploidentical or cord blood transplant
. Active GVHD grade II or higher (acute GVHD Clinical Staging and Grading)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Relapse free survival (RFS)

Timeframe: 12 months

Trial details

NCT IDNCT04173533

SponsorUniversity of Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-29

View on ClinicalTrials.gov More Acute Myeloid Leukemia trials