ROMAZA trial

Chief investigator - Professor Charles Craddock, University Hospital Birmingham
Phase I trial of romidepsin plus azacitidine in patients with newly diagnosed, relapsed or refractory acute myeloid leukaemia ineligible for conventional chemotherapy
Award start date: 01 Jan 2013
Recruitment start date: 30 Sep 2013

People with acute myeloid leukaemia (AML) are usually given chemotherapy, but not everyone can have this type of treatment. Researchers think that combining azacitidine with romidepsin may help people with AML who can’t have standard chemotherapy treatment.

Azacitidine is a type of chemotherapy drug that doctors already use to treat people with AML. Its exact mechanism of action is unknown, and it has more than one effect on cells. In AML, important genes that regulate cell growth and division are turned off by methyl groups becoming attached to the cells’ DNA, allowing cells to grow out of control. Azacitidine can act as a demethylating agent, removing the methyl groups and restoring normal gene function.

Romidepsin is a new HDAC inhibitor – a drug that blocks enzymes called histone deacetylases, which cells need to grow and divide. It has provided clinical benefit in people with lymphoma, but to date has not been studied in combination with azacitidine in people with AML.

The aims of this trial were:

  • To find out what is the highest dose of romidepsin to give with azacitidine
  • See how safe it is to give romidepsin with azacitidine
  • Assess how well this combination of drugs work for people with AML

This trial is closed for recruitment, and we hope to update you with the results soon.