VIOLA – Azacitidine and Lenalidomide Salvage Therapy13 Aug. 2018
*CLOSED TO RECRUITMENT*
- SUB-TYPE OF MDS: Relapsed MDS after undergoing an Allogeneic Stem Cell Transplantation); also for Acute Myeloid Leukaemia
- SEVERITY OF MDS: All
- NAME OF DRUG: Azacitidine and Lenalidomide
- 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.
- 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
- 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
- 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
- More information:
Please read information and always discuss trial information with your own physician.