Eligibility DRKS00003838 NCT00701766 Leukemia, Myeloid, Acute Inclusion Criteria Exclusion Criteria Patient with acute promyelocytic leukaemia (APL, AML of the French-American-British (FAB) classification subtype M3) Yes
No
Hypersensitivity to the trial drug or the excipients Yes
No
Secondary malignancy requiring therapy Yes
No
Central nervous system (CNS) involvement status Yes
No
Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 times the upper limit of normal, or AST or ALT > 5 times the upper limit of normal in case of known liver involvement Yes
No
Bilirubin > 1.5 mg/dl (> 26 mcmol/l, SI unit equivalent) Yes
No
Serum Creatinine Measurement Yes
No
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 Yes
No
Psychiatric illness or social situation that would limit compliance with trial requirements Yes
No
Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug Yes
No
Chemotherapy (except hydroxyurea) or immunotherapy or treatment with any other investigational drug within the past four weeks prior to treatment with the trial drug Yes
No
Persistence of toxicities of prior anti-leukaemia therapies which are deemed to be clinically relevant Yes
No
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.) Yes
No
Patient unable to comply with the protocol Yes
No
