AZTEC: 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

Trial Overview and Summary

Bone marrow (stem cell) transplantation is effective in curing patients of leukaemia and lymphoma. 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. cGvHD may respond to drugs such as steroids but these  can lead to complications. Azacitidine is a novel drug that has been shown to increase the number of normal 'regulatory' cells to control the activity of the immune system. This study will determine the value of this drug in patients with cGvHD who do not respond to steroids.

Please note that the trials team cannot give individuals clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible

Chief Investigator: Dr Ram Malladi
Sponsor: University of Birmingham
Funders: Bloodwise and Celgene
Disease Site: Graft versus Host Disease
Trial Type: Clinical Trial of an Investigational Medicinal Product
Status: Open
Open to new sites? Yes
Recruitment start date: 01-Mar-2016
Anticipated Recruitment end date: December 2019  
CRCTU Trial Management Team: Haematology Team
Trial E-mail Address:

Trial Protocol

Please Note:

Clinical trial protocols are complex technical documents which should only be used for the treatment of subjects taking part in the trial. Patients who are interested in taking part in the trial are advised to talk to their health care professional.