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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed acute myeloid leukemia (AML) who achieve a second complete remission (CR).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cephalon
• Treatments: Cytarabine; Etoposide; Mitoxantrone

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