A Randomized, Open-Label Study of Oral CEP-701 Administered in Sequence With Standard Chemotherapy to Patients With Relapsed Acute Myeloid Leukemia (AML) Expressing FLT-3 Activating Mutations

Study start date: October 1, 2003

Inclusion criteria: * cytological confirmation of AML; * relapsed disease following first CR of 1 month(30days)to 24 months(730days). The time from first relapse to study entry (start of first course of induction chemotherapy) must be no longer than 30days; * confirmation of FLT-3 activating mutation positive status after point of initial relapse; * aged 18 years or older; * written informed consent; * ability to understand and comply with study restrictions; * no comorbid conditions that would limit life expectancy to less than 3 months; * ECOG Performance Score of 0, 1,or 2; * women must be neither pregnant nor lactating, and either of non-childbearing potential or using adequate contraception with a negative pregnancy test at study entry Exclusion criteria: * bilirubin \> 2x ULN; * ALT/AST \> 3x ULN; * serum creatinine \> 1.5 mg/dL; * resting ejection fraction of left ventricle l \< 45%(applies only to patients scheduled to receive mitoxantrone, etoposide, and cytarabine \[MEC\]; * untreated or progressive infection; * any physical or psychiatric cdtn that may compromise participation in the study; * known CNS involvement with AML; * any previous treatment with a FLT-3 inhibitor; * requires current treatment for HIV with protease inhibitors; * active GI ulceration or bleeding; * use of an investigational drug that is not expected to be cleared by the start of CEP-701 treatment