FIGARO
Research type
Research Study
Full title
A Randomised Trial of the FLAMSA-BU Conditioning Regimen in Patients with Acute Myeloid Leukaemia and Myelodysplasia Undergoing Allogeneic Stem Cell Transplantation
IRAS ID
125464
Contact name
Charles Craddock
Contact email
Eudract number
2012-005538-12
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.
Recent studies in Europe appear to have identified a new form of transplant regimen (FLAMSA-BU) which is associated with improved outcomes in older patients because of both reduced rates of toxicity and disease relapse.
We therefore propose to compare the new FLAMSA-BU transplant with currently used transplant regimens. We plan to enrol 170 patients with high risk AML and MDS allowing us to compare the benefits in terms of toxicity, disease relapse and overall survival. This is the first such study in the world and will serve to inform the medical community of how best to treat older patients with high risk AML and MDS.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
13/YH/0152
Date of REC Opinion
3 Jun 2013
REC opinion
Further Information Favourable Opinion