Originele protocol

Inclusion criteria

  • Age 60 years or more
  • Subjects with a cytopathologically confirmed diagnosis of
    (a) AML (M0-M2 and M4-M7, FAB classification, appendix A), or
    (b) refractory anemia with excess of blasts (RAEB) or refractory anemia with excess of blasts in transformation (RAEB-t) with an IPSS score of >1.5 (appendix C)
    Note: Subjects with a secondary AML progressing from antecedent myelodysplasia and biphenotypic leukaemia are eligible.
  • Less than 5% bone marrow blasts and absence of Auer rods after 2 cycles of induction therapy (this induction therapy can be according to HOVON81, HOVON92 or similar protocols. Of note: also patients who are treated according to one of these protocols but were not formally included in these studies are eligible for HOVON97)
  • Hematological recovery, i.e. ANC ≥ 0.5 x 109/l and platelets ≥ 50 x 109/l
  • WHO performance status ≤ 2 (see appendix F)
  • Written informed consent

Exclusion criteria

  • Extramedullary disease
  • Planned allogeneic hematopoietic cell transplantation
  • Previous polycythaemia rubra vera
  • Primary myelofibrosis
  • Blast crisis of chronic myeloid leukemia
  • AML-FAB type M3 or AML with cytogenetic abnormality t(15;17)
  • Impaired hepatic or renal function as defined by:
    • ALT and/or AST > 2.5 x normal value
    • Bilirubin > 2 x normal value
    • Serum creatinin > 2 x normal value (after adequate hydration)
  • Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.)
  • 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 MUGA scan or echocardiogram (another method for measuring cardiac function is acceptable)
    • Unstable angina
    • Unstable cardiac arrhythmias