A phase II multicentre study to assess the tolerability and efficacy of the addition of bevacizumab to standard induction therapy in Acute Myeloid Leukaemia and high risk myelodysplastic syndrome above 60 years

INTERVENTION: Patients will be randomised on entry between: Arm A: Cycle I: daunorubicine/cytarabine‐arabinoside Cycle II: intermediate dose cytarabine‐arabinoside. Arm B: Cycle I: daunorubicine/cytarabine‐arabinoside and two doses of bevacizumab 5 or 10 mg/kg Cycle II: intermediate dose cytarabine‐arabinoside and two doses of bevacizumab 5 or 10 mg/kg CONDITION: Myeloid Leukaemia ; Cancer ; Myeloid Leukaemia PRIMARY OUTCOME: Incidence of Dose‐Limiting Toxicity (DLT) and the effect of bevacizumab on the CR‐rate. SECONDARY OUTCOME: 1. Overall survival (time from registration until the death of the patient); 2. Event free survival (i.e., time from registration to induction failure, death or relapse whichever occurs first); 3. Minimum Residual Disease (MRD) percentage INCLUSION CRITERIA: 1. Patients greater than 60 years 2. Patients eligible for standard chemotherapy 3. Patients with a confirmed diagnosis of Acute Myeloid Leukaemia (AML) French‐American‐British (FAB) classification M0 ‐ M2 or M4 ‐ M7 or with Refractory Anaemia with Excess of Blasts (RAEB) or Refractory Anaemia with Excess of Blasts in Transformation (RAEB‐T) with an International Prognostic Scoring System (IPSS) score greater than or equal to 1.5 4. Subjects with secondary AML progressing from antecedent (at least four months duration) myelodysplasia are also eligible. 5. Serum Glutamic Oxaloacetic Transaminase (SGOT) (Aspartate aminotransferase [AST]) and Serum Glutamic Pyruvic Transaminase (SGPT) (Alanine Aminotransferase [ALT]) less than or equal to 1.5 x the Upper Limit of the Normal range (ULN) at the laboratory where the analyses were performed 6. Total serum bilirubin level less than or equal to 1.5 x the ULN at the laboratory where the analysis was performed<