Eligibility DRKS00003838 NCT00701766 Leukemia, Myeloid, Acute Einschlusskriterien Ausschlusskriterien Patient with acute promyelocytic leukaemia (APL, AML of the French-American-British (FAB) classification subtype M3) Ja
Nein
Hypersensitivity to the trial drug or the excipients Ja
Nein
Secondary malignancy requiring therapy Ja
Nein
Zentralnervensystembeteiligung, Status Ja
Nein
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 Ja
Nein
Bilirubin > 1.5 mg/dl (> 26 mcmol/l, SI unit equivalent) Ja
Nein
Kreatinin im Serum Ja
Nein
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 Ja
Nein
Psychiatric illness or social situation that would limit compliance with trial requirements Ja
Nein
Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug Ja
Nein
Chemotherapy (except hydroxyurea) or immunotherapy or treatment with any other investigational drug within the past four weeks prior to treatment with the trial drug Ja
Nein
Persistence of toxicities of prior anti-leukaemia therapies which are deemed to be clinically relevant Ja
Nein
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.) Ja
Nein
Patient unable to comply with the protocol Ja
Nein
