Originele protocol

Inclusion criteria

  • Age 18-65 years, inclusive
  • Subjects with
    • a cytopathologically confirmed diagnosis of AML according WHO classification (excluding acute promyelocytic leukaemia) or
      • a diagnosis of refractory anemia with excess of blasts (RAEB) and IPSS score >=1.5 or
      • patients with therapy-related AML/RAEB or
      • patients with biphenotypic leukemia (Appendices A1 and A2).
    • Adequate renal and hepatic function tests as indicated by the following laboratory values:
      • Serum creatinine <=1.0 mg/dl (<= 88.7 micromol/L); if serum creatinine >1.0 mg/dl (>88.7 micromol/L), then the glomerular filtration rate (GFR) must be >60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation where the predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine in mg/dl)-1.154 x (age in years)-0.023 x (0.742 if patient is female) x (1.212 if patient is black)
        NOTE: if serum creatinine is measured in micromol/L, recalculate it in mg/dl according to the equation: 1 mg/dl = 88.7 micromol/L) and used above mentioned formula.
      • Serum bilirubin <=1.5 × upper limit of normal (ULN)
      • Aspartate transaminase (AST)/alanine transaminase (ALT) <=2.5 × ULN
      • Alkaline phosphatase <= 2.5 × ULN
    • WHO performance status 0, 1 or 2 (see Appendix I)
    • Written informed consent

Exclusion criteria

  • Acute promyelocytic leukaemia
  • Previous treatment for AML or RAEB, except hydroxyurea
  • Concurrent history 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 MUGA scan or echocardiogram (another method for measuring cardiac function is acceptable), or
    • Unstable angina, or
    • Unstable cardiac arrhythmias
  • Pregnant or lactating females
  • Unwilling or not capable to use effective means of birth control


Klik hier voor flowschema.