All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Inclusion Criteria:

• Newly diagnosed AML defined according to the World Health Organization (WHO)classification (excluding acute promyelocytic leukemia [APL])

• Aged > 60 years

• All patients have to be informed about the character of the study. Written informedconsent of each patient at study entry.

• Molecular and cytogenetical analyses on initial bone marrow and peripheral bloodspecimen have to be performed at the central reference laboratories.

Exclusion Criteria:

• Bleeding independent of the AML

• Acute promyelocytic leukemia

• Uncontrolled infection

• Participation in a concurrent clinical study

• Insufficiency of the kidneys (creatinine > 1.5 x upper normal serum level), of theliver (bilirubin, AST or AP > 2 x upper normal serum level), severe obstruction orrestrictive ventilation disorder, heart failure New York Heart Association [NYHA]III/IV

• Severe neurological or psychiatric disorder interfering with ability of givinginformed consent

• No consent for the registration, storage and processing of data concerning thecharacteristics of the AML and the individual course

• Performance status WHO > 2