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

Patients randomly assigned to chemotherapy alone received the second course of induction chemotherapy as soon as clinically indicated; patients randomly assigned to receive chemotherapy plus sequential lestaurtinib had lestaurtinib withheld for 3 days (72 hours) before the start of the second 5-day course of chemotherapy and resumed lestaurtinib treatment 2 days (48 hours) after the final administration of the second course of chemotherapy.

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