COSI
Research type
Research Study
Full title
An International Randomised Clinical Trial of Therapeutic Interventions with the Potential to Improve Outcome in Adults with Acute Myeloid Leukaemia and High Risk Myelodysplasia Undergoing Allogeneic Stem Cell Transplantation
IRAS ID
252254
Contact name
Dr Catherine Cochrane
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2017-004801-42
Clinicaltrials.gov Identifier
ERN_17-1572, Ethics self assessment number
Duration of Study in the UK
6 years, 0 months, 1 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 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
2. Comparing a new conditioning therapy in patients under the age of 55 years
3. Comparing new conditioning therapies in patients aged 55 and over
Up to 869 patients will be ‘randomised’ to the trial to compare the outcomes between the different treatment regimens. Patients will be followed up for a minimum of 2 yearsREC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0135
Date of REC Opinion
17 May 2019
REC opinion
Further Information Favourable Opinion