MicroLEN: This phase I trial is evaluating the safety and recommended dose of an oral therapy (Lenalidomide) in patients with Acute Myeloid Leukaemia or Myelodysplastic Syndrome at high risk of relapseA Phase I study to assess the safety of micro-dose lenalidomide as maintenance therapy post-allogeneic haematopoietic cell transplantation for patients with acute myeloid leukaemia or myelodysplastic syndromes, at high risk of relapse

Inclusion

Each patient must have one of the following:
a. High risk AML, defined as any of:
• Not in complete remission (CR) at time of alloHSCT
• Adverse risk cytogenetics at any stage of disease
• FLT3-ITD mutation
• Prior induction failure
• Evidence of pre-transplant minimal residual disease either by cytogenetics or by flow cytometry. If flow cytometry is the selected method used, MRD must be greater than 0.1%.
• In second complete remission if duration of first complete remission was less than or equal to 6months.
• Transformation from myeloid neoplasm at any stage

OR

b. High risk MDS, defined as any of:
• Adverse risk cytogenetics at any stage of disease
• Over 10% blasts in blood or marrow aspirate pre-transplant

AND must meet ALL of the following general inclusion criteria:
a. Age 18 years or older.
b. No prior exposure to lenalidomide.
c. Alkaline phosphatase and transaminases less than or equal to 2 x ULN
d. Creatinine clearance greater than or equal to 30 ml/min (calculated by Cockcroft-Gault formula
e. Females of childbearing potential must use an effective method of contraception or practice absolute abstinence for 4 weeks prior to lenalidomide therapy, during treatment and 4 weeks after treatment discontinuation
f. Male patients must use contraception during lenalidomide treatment and for 1 week after completion of treatment
g. ECOG performance status 0-2
h. Life expectancy greater than 6 months
i. Patient’s written informed consent
j. Subjects must agree not to share their medication and return unused supplies