BI 2536 Infusional Treatment in Patients Over 60 Years of Age With Refractory or Relapsed Acute Myeloid Leukaemia

Inclusion Criteria: * Male or female patients older than 60 years of age * Patient with confirmed AML (except for APL) according to the WHO definition who relapsed after or are refractory to prior chemotherapy * Leukocyte count \<= 25,000 /mcl (25 x 10e9/Liter) * Patient not eligible for intensive treatment options * Life expectancy \>= 2 months * Eastern co-operative oncology group performance score of 2 or less * Signed written informed consent consistent with international conference on harmonisation - good clinical practice (ICH-GCP) and local legislation Exclusion Criteria: * Patient with acute promyelocytic leukaemia (APL, AML of the French-American-British (FAB) classification subtype M3) * Hypersensitivity to the trial drug or the excipients * Secondary malignancy requiring therapy * Known central nervous system involvement * Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal, or AST or ALT greater than 5 times the upper limit of normal in case of known liver involvement * Bilirubin greater than 1.5 mg/dl (\> 26 mcmol/l, SI unit equivalent) * Serum creatinine greater than 2.0 mg/dl * Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris or cardiac arrhythmia * Psychiatric illness or social situation that would limit compliance with trial requirements * Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug * Chemotherapy (except hydroxyurea) or immunotherapy or treatment with any other investigational drug within the past four weeks prior to treatment with the trial drug * Persistence of toxicities of prior anti-leukaemia therapies which are deemed to be clinically relevant * Patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial (hormonal contraception, intrauterine device, condom with spermicide, etc.) * Patient unable to comply with the protocol