A Trial of Treatments to Assess the Effects on Outcome of Adults With AML and MDS Undergoing Allogeneic SCT

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 new transplant strategies with the aim of improving the outcome of patients with AML and high risk MDS after stem cell transplantation. Three approaches to improve transplant outcome will be studied: 1. Comparing the new pre-transplant consolidation therapy vyxeos with the standard consolidation therapy (Randomisation 1 is now closed to recruitment). 2. Comparing new conditioning therapies in patients under the age of 55 years 3. Comparing new conditioning therapies in patients aged 55 and over All patients will be followed up for a minimum of 2 years.

NCT Number	NCT04217278
Lead Sponsor	University of Birmingham Collaborators: Jazz Pharmaceuticals, Adienne SA
Conditions	Acute Myeloid Leukaemia, High-risk Myelodysplastic Syndrome
Enrollment	333 participants
Start Date	2020-01-27
Primary Completion	2026-05 (estimated)
Study Completion	2026-05 (estimated)
Updated on ClinicalTrials.gov	2026-05-05