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

Inclusion Criteria

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