HOVON 103

Originele protocol

Inclusion criteria

  • 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)
    OR
  • 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.

Exclusion criteria

  • 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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