- Patients eligible for standard chemotherapy.
- Patients ≥ 66 years with a cytopathologically confirmed diagnosis according WHO classification of AML (not APL, see appendix A1) or refractory anemia with excess of blasts (RAEB, see appendix A2) with an IPSS score ≥ 1.5 (see Appendix B)
- Patients of any age ≥ 18 years with a cytopathologically confirmed diagnosis according WHO classification of AML with very poor risk AML (see appendix D).
- Subjects with secondary AML progressing from antecedent (at least 4 months duration) myelodysplasia are also eligible.
- SGOT (AST) and SGPT (ALT) ≤ 1.5 x the upper limit of the normal range (ULN) at the laboratory where the analyses were performed.
- Total serum bilirubin level ≤ 1.5 x the ULN at the laboratory where the analysis was performed.
- Serum creatinine concentration ≤ 1.5 x the ULN at the laboratory where the analysis was performed.
- WHO performance status ≤ 2 (see Appendix F)
- Written informed consent.
- Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
- Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
- Acute promyelocytic leukemia
- Patients previously treated for AML (any antileukemic therapy including investigational agents), a short treatment period (< 2 weeks) with Hydroxyurea is allowed.
- Past or current history (within the last 2 years prior to randomization) of malignancies except for the indication under this study and curatively treated:
- Basal and squamous cell carcinoma of the skin
- in situ carcinoma of the cervix
- Blast crisis of chronic myeloid leukemia
- Clinically significant (i.e. active) cardiovascular disease, for example cerebrovascular accidents (≤ 6 months prior to randomization), myocardial infarction (≤ 6 months prior to randomization), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (see Appendix I),
- Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance
- Patients with any serious concomitant medical condition which could, in the opinion of the investigator, compromise participation in the study.
- Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.
- Pregnant or lactating patients.
- Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
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