Study of CEP-701 (Lestaurtinib) in Patients With Acute Myeloid Leukemia (AML)

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