AZTEC
Research type
Research Study
Full title
A phase II study of the use of azacitidine for the treatment of patients with chronic graft-versus-host-disease who have failed therapy with corticosteroids
IRAS ID
178108
Contact name
Ram Malladi
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2014-005659-19
Duration of Study in the UK
4 years, 0 months, 3 days
Research summary
Bone marrow (stem cell) transplantation can be effective in curing patients of leukaemia and lymphoma. However a major complication is graft-versus-host-disease (GvHD), a condition in which the donor immune system recognises the patient's normal cells as 'foreign' and attacks them leading to organ damage. Chronic GvHD (cGvHD) occurs several months following transplant and can affect a number of tissues leading to severe disability, poor quality of life and even death.
cGvHD may respond to drugs such as steroids which suppress the immune system but these have serious complications of their own, especially when taken for long periods of time in patients with severe cGvHD. Many other drugs have been tried but they have not been found to be any more effective than steroids.
Azacitidine is a novel drug that is showing promise as an agent against GvHD when it has been has been given to patients following stem cell transplants as part of recent clinical trials. We know that azacitidine treats GvHD in mice and has already been safely given to stem cell transplant patients. This study aims to determine the value of this drug in patients with cGvHD who do not respond to, or have become dependent on, steroids. Up to 35 patients in the UK will be recruited to the study.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
15/EM/0440
Date of REC Opinion
21 Oct 2015
REC opinion
Further Information Favourable Opinion