ROMAZA: Phase I trial of combination therapy with romidepsin and azacitidine in patients with newly diagnosed, relapsed or refractory acute myloid leukaemia ineligible for conventional chemotherapy

Trial Overview and Summary

Treatment options for older adults with acute myeloid leukaemia (AML) are limited. Drugs called epigenetic therapies offer new treatment options for patients with AML. The most widely used epigenetic therapy in AML is azacitidine. Trials have demonstrated higher responses when azacitidine is combined with a drug called a histone deacetylase inhibitor (HDACi). Romidepsin is a new HDACi which has shown a benefit in patients with lymphoma, but it has not been tested in AML. This is the first study combining romidepsin and azacitidine in AML, aiming to determine the best combined dose of the drugs to give to patients. 

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: TAP Bloodwise and Celgene
Disease Site: Acute Myloid Leukaemia
Trial Type: Clinical Trial of an Investigational Medicinal Product
Status: Open 
UKCRN Study ID: (if applicable) 15082
Open to new sites? No
Recruitment start date: 03-Oct-2013
Anticipated Recruitment end date 31-Mar-2016
CRCTU Trial Management Team: Haematology
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 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.

Trial Documents [opens a new page]

More Information

Cancer Help (Cancer Research UK) [opens new page]