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

Completed · Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

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).

Key facts

Study ID

NCT00079482

Run by

Cephalon

People needed

224

Starts

2003-10-01

Expected to finish

2010-01-01

Last updated by the study team

2016-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo-Scottsdale — Scottsdale, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• USC/Norris Cancer Center — Los Angeles, California, United States
• Stanford Medical Center — Stanford, California, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• ACORN-Central Georgia Hematology/Oncology — Macon, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• St. Francis Cancer Care Services — Beech Grove, Indiana, United States
• Indiana Cancer Pavillion — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• LSU Shreveport — Shreveport, Louisiana, United States
• Univeristy of Maryland Medicine - Greenebaum Cancer Center — Baltimore, Maryland, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Tufts New England Medical Center — Boston, Massachusetts, United States
• Beth Israel Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute Wayne State University — Detroit, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• The Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• University of Nebraska — Omaha, Nebraska, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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