VIOLA: A Phase I Trial of Combined Azacitidine and Lenalidomide Salvage Therapy in Patients who have relapsed after undergoing an Allogeneic Stem Cell Transplantation for Acute Myeloid Leukaemia (AML) or Myelodysplasia (MDS)

Trial Overview and Summary

Treatment options for patients with acute myeloid leukaemia (AML) who relapse following an allogeneic stem cell transplant are limited and most will die of resistant leukaemia. Two drugs, Azacitidine (AZA) and Lenalidomide (LEN), have both been shown to have marked clinical activity in patients with AML who have failed to respond to conventional chemotherapy. Combined treatment with AZA and LEN has never been examined in this important patient population. This study will determine the best tolerated combined dose of AZA and LEN in patients who have relapsed after an allogeneic stem cell transplant.

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: Professor Charles Craddock


Sponsor: University of Birmingham


Funders: Bloodwise (Trials Acceleration Programme) and Celgene


Disease Site: Acute Myeloid Leukaemia and Myelodysplasia


Trial Type: Clinical Trial of an Investigational Medicinal Product


Status: Closed




Open to new sites? No


Recruitment start date: 05-Feb-2014


Anticipated Recruitment end date: 31-Dec-2016


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 or refer to CancerHelp website [opens new page].

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

More information

  • CancerHelp (Cancer Research UK) - VIOLA trial [opens new page]