Clinical Trial: Study of CEP-701 in Patients with Acute Myeloid Leukemia (AML)


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Sponsored by:	Cephalon
Information provided by:	Cephalon

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).

Condition	Treatment or Intervention	Phase
Acute Myeloid Leukemia	Drug: lestaurtinib	Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: 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

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Inclusion criteria:

cytological confirmation of AML;
relapsed disease following first CR of 1 month to 24 months duration;
confirmation of FLT-3 activating mutation positive status after point of initial relapse;
aged 18 years or older;
life expectancy greater than 3 mos.;
ECOG Performance Status of 0, 1, 2

Exclusion criteria:

bilirubin > 2x ULN;
ALT/AST > 3x ULN;
serum creatinine > 1.5 mg/dL;
untreated or progressive infection;
known CNS involvement with AML;
any prior treatment with FLT-3 inhibitor;
active GI ulceration or bleeding;
patient requires treatment for HIV with protease inhibitors;
use of investigational drug within 30 days of baseline visit

Indiana
Indiana Cancer Pavillion, Indianapolis, Indiana, 46202, United States; Recruiting

Cheryl Rutledge 317-274-0901 ckrutled@iupui.edu
Larry Cripe, MD, Principal Investigator

Maryland
Johns Hopkins, Baltimore, Maryland, 21231, United States; Recruiting

Doug Smith, MD 410-614-5068 smithdo@jhmi.edu
Doug Smith, MD, Principal Investigator

Michigan
University of Michigan, Ann Arbor, Michigan, 48109, United States; Recruiting

Irene Ryan 734-647-9757 iryan@umich.edu
Harry Erba, MD, Principal Investigator

Minnesota
The Mayo Clinic, Rochester, Minnesota, 55905, United States; Recruiting

Colleen Irlbeck 507-538-0107 irlbeck.colleen@mayo.edu
Mark Litzow, MD, Principal Investigator

Nebraska
University of Nebraska, Omaha, Nebraska, 68198, United States; Recruiting

Patricia Pedersen 402-559-4810 ppedersen@unmc.edu
Marcel Devetton, MD, Principal Investigator

Texas
MD Anderson Cancer Center, Houston, Texas, 77030, United States; Recruiting

Miloslav Beran, MD 713-792-2248 mberan@mdanderson.org
Miloslav Beran, MD, Principal Investigator

Study ID Numbers: C701a/204/ON/US
Record last reviewed: February 2004
Record first received: March 8, 2004
ClinicalTrials.gov Identifier: NCT00079482
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10