VIOLA – Azacitidine and Lenalidomide Salvage Therapy


  1. SUB-TYPE OF MDS: Relapsed MDS after undergoing an Allogeneic Stem Cell Transplantation); also for Acute Myeloid Leukaemia
  3. NAME OF DRUG: Azacitidine and Lenalidomide
  4. Aims and benefits: This is a dose finding trial to determine the maximum tolerated dose (MTD) of lenalidomide in combination with azacitidine therapy in this patient group. Patients will be treated for 6 cycles of therapy (each cycle being 42 days) plus continuation at clinicians’ discretion.
  5. Basic inclusion criteria:
    • Patients with relapsed AML or MDS following an alemtuzumab or anti-thymocyte globulin (ATG)-based reduced intensity conditioned allogeneic stem cell transplant using a sibling or unrelated donor.
    • Able to receive treatment as an outpatient
  6. Basic exclusion criteria:
    • Patients with active acute or chronic extensive graft-versus-host-disease (GvHD), or a history of grade 3 or 4 GvHD
    • Patients with hepatic or renal impairment
    • Patients who have received anti-tumour therapies, including prior experimental agents or approved anti-tumour small molecules and biologics, within 28 days before the start of protocol treatment
    • Patients with active symptomatic fungal, bacterial, and/or viral infection
  7. Trial sites/locations and name of physician in charge of trial: 
    Queen Elizabeth Hospital, Birmingham;
    Christie Hospital, Manchester;
    St Bartholomew’s Hospital, London;
    Beatson West of Scotland Cancer Centre, Glasgow;
    University Hospital of Wales, Cardiff;
    St James’s University Hospital, Leeds;
    Manchester Royal Infirmary
  8. More information:

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