Originele protocol

Inclusion criteria

  • Age 18-65 years, inclusive
  • Patients with
    • a diagnosis of AML and related precursor neoplasms according to WHO 2008 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML), or
    • acute leukemia’s of ambiguous lineage according to WHO 2008 or
    • a diagnosis of refractory anemia with excess of blasts (MDS) and IPSS-R score > 4.5
  • WHO performance status 0, 1 or 2
  • Sampled bone marrow and/ blood cells at diagnosis for centralized molecular analysis, MRD evaluation and biobanking, unless in case of a dry marrow tap with no possibility to collect marrow cells. In cases of marrow tap failure only blood cells will be sampled.
  • Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values:
    • Serum creatinine ≤1.0 mg/dL (≤88.7 µmol/L); if serum creatinine >1.0 mg/dL (>88.7 µmol/L), then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine in mg/dL)-1.154 x (age in years)-0.203 x (0.742 if patient is female) x (1.212 if patient is black)

NOTE: if serum creatinine is measured in µmol/L, recalculate it in mg/dL according to the equation: 1 mg/dL = 88.7 µmol/L) and use above mentioned formula.

    • Serum bilirubin ≤2.5 x upper limit of normal (ULN)
    • Aspartate transaminase (AST) ≤ 2.5 x ULN
    • Alanine transaminase (ALT) ≤ 2.5 x ULN
    • Alkaline phosphatase ≤ 2.5 x ULN
  • Written informed consent
  • Ability and willingness to adhere to the lenalidomide Pregnancy Prevention Program

Exclusion criteria

  • Previous therapy with lenalidomide
  • Acute promyelocytic leukemia
  • Myeloproliferative neoplasia
  • Previous treatment for AML or high risk MDS (IPSS-R > 4.5), except hydroxyurea
  • Concurrent history of active malignancy in two past years prior to diagnosis except for:
    • basal and squamous cell carcinoma of the skin
    • in situ carcinoma of the cervix
  • Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etcetera)
  • Cardiac dysfunction as defined by:
    • Myocardial infarction within the last 6 months of study entry, or
    • Reduced left ventricular function with an ejection fraction < 50% as measured by MUG scan or echocardiogram or
    • Unstable angina, or
    • Unstable cardiac arrhythmias
  • Pregnant or lactating females
  • Unwilling or not capable to use effective means of birth control
  • Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule