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
