VIOLA (Version 1.0 15-Oct-2013)
Research type
Research Study
Full title
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) (VIOLA)
IRAS ID
141146
Contact name
Charles Craddock
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2013-002118-11
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Treatment options for patients with acute myeloid leukaemia (AML) who relapse following an allogeneic stem cell transplant (SCT) are extremely limited and most will die of resistant leukaemia. Two drugs, Azacitidine and lenalidomide, have both been shown to have marked clinical activity in patients with AML who have failed to respond to conventional chemotherapy. Of interest, combined treatment with both azacitidine and lenalidomide appears to increase the response rate in patients with AML. Importantly, a number of small studies have demonstrated that both azacitidine and lenalidomide when administered alone can also be clinically active in patients who relapse after a stem cell transplant. To date however, combined treatment with azacitidine and lenalidomide has never been examined in this important patient population. In this study, we plan to determine the best tolerated combined dose of azacitidine and lenalidomide in patients who have relapsed after an allogeneic stem cell transplant. The information produced will inform the design of future clinical trials in patients with AML whose disease has relapsed after an allogeneic transplant. The trial will run in approximately 6 hospitals in the UK. Approximately 27 patients will be recruited to this phase 1 trial.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
13/SC/0581
Date of REC Opinion
21 Jan 2014
REC opinion
Further Information Favourable Opinion