VIOLA trial

Chief investigator - Professor Charles Craddock, University Hospital Birmingham
A phase I trial of combined azacitidine and lenalidomide salvage therapy in patients with acute myeloid leukaemia who relapse after allogeneic stem cell transplantation
Award start date: 01 Sep 2013
Recruitment start date: 05 Feb 2014
Award duration: 4 years (52 months)

People with acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) are usually treated with high doses of chemotherapy, followed by a stem cell transplant. But AML and MDS can come back after a transplant, and when it does it becomes much more difficult to treat.

Two new drugs called azacitidine and lenalidomide may help people with AML and MDS who have relapsed after a stem cell transplant.

Azacitidine is a type of chemotherapy drug that doctors already use to treat people with AML and MDS. Its exact mechanism of action is unknown, and it has more than one effect on cells. In AML and MDS, 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.

Lenalidomide is a complicated drug with several mechanisms of action affecting lots of cell processes, including modifying the way the immune system works.

A number of small studies have demonstrated that both azacitidine and lenalidomide when administered alone can be effective in treating people with AML who relapse after a stem cell transplant. But combined treatment with azacitidine and lenalidomide has never been tested in this group of people.

The aims of the trial are to:

  • Find the highest dose of lenalidomide that people can safely have with azacitidine
  • Learn more about the side effects of this drug combination
  • See if the treatment helps people with AML or MDS that has come back after a stem cell transplant

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