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The AML16 trial evaluated the combination of the farnesyltransferase inhibitor, tipifarnib, and low dose cytarabine (LDAC) in older acute myeloid leukaemia (AML) patients in a 'Pick a Winner' design. The aim was to double remission rates compared to LDAC, with initial evaluation after 100 patients. Failure to improve remission would result in discontinuation. A total of 65 patients, median age 74 years (range 62-86), were randomized. After reviewing the first 45 patients, the Data Monitoring Committee concluded that the overall aspirations would not be met and recommended closure. The addition of tipifarnib had no effect on response, toxicity or survival.

Original publication




Journal article


Br J Haematol

Publication Date





519 - 522


Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Cytarabine, Enzyme Inhibitors, Farnesyltranstransferase, Female, Humans, Leukemia, Myeloid, Acute, Male, Middle Aged, Quinolones, Survival Analysis, Treatment Outcome