Phase II Randomised Trial of 5-Azacitidine versus 5-Azacitidine in combination with Vorinostat in patients with Acute Myeloid Leukaemia or High Risk Myelodysplastic Syndromes Ineligible for Intensive Chemotherapy

Trial Overview and Summary

Treatment options for older adults with Acute Myeloid Leukaemia (AML) are limited. Abnormalities in DNA structure play an important role in the development of AML. New drugs, called epigenetic therapies, reverse these abnormalities, are clinically active and relatively well tolerated. The most widely used epigenetic therapy in AML is azacitidine, which produces responses in 15% of patients. Trials have demonstrated higher response rates when azacitdine is combined with drugs such as vorinostat. This is the first randomised trial to study whether the addition of vorinostat to azacitidine improves the response rate and overall survival of patients with AML. 

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

Chief Investigator: Professor Charles Craddock  
Sponsor: University of Birmingham  
Funders: Bloodwise (Trials Acceleration Programme) and Celgene  
Disease Site: Acute Myeloid Leukaemia and Myelodysplastic Syndrome  
Trial Type: Clinical Trial of an Investigational Medicinal Product  
Status: Follow-up  
UKCRN Study ID: 12452  
Open to new sites? No  
Recruitment start date: 12-Nov-2012  
Recruitment end date: 30-Sep-2015  
CRCTU Trial Management Team: Haematology Team  
Trial E-mail Address: ravva@trials.bham.ac.uk  

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 or refer to CancerHelp website.

Investigators please ensure you have R&D approval for this specific version of the protocol before using as a reference.