Study of CEP-701 (Lestaurtinib) in Patients With Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML
Eligibility 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
Sites / Locations
- University of Alabama
- Mayo-Scottsdale
- University of Arkansas for Medical Sciences
- USC/Norris Cancer Center
- Stanford Medical Center
- Moffitt Cancer Center
- Emory University School of Medicine
- ACORN-Central Georgia Hematology/Oncology
- Northwestern University
- University of Chicago
- St. Francis Cancer Care Services
- Indiana Cancer Pavillion
- University of Iowa Hospitals and Clinics
- LSU Shreveport
- Univeristy of Maryland Medicine - Greenebaum Cancer Center
- Johns Hopkins
- Tufts New England Medical Center
- Beth Israel Hospital
- University of Michigan
- Karmanos Cancer Institute Wayne State University
- University of Minnesota
- The Mayo Clinic
- Washington University
- University of Nebraska
- Roswell Park Cancer Institute
- New York Presbyterian
- Duke University Medical Center
- The Cleveland Clinic Foundation
- University of Pennsylvania
- University of Pittsburgh
- Medical University of South Carolina
- ACORN-The West Clinic
- MD Anderson Cancer Center
- University of Washington Medical Center
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- Princess Margaret Hospital
- CHA Hospital Enfant-Jesus
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Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
1
2
Induction chemotherapy with or without sequential treatment with oral CEP-701 at 80 mg bid. For patients with duration of first CR of 1 to 6 months, the induction regimen will be MEC.
Induction chemotherapy with or without sequential treatment with oral CEP-701 at 80 mg bid. For patients with duration of first CR of more than 6 months to 24 months, the induction regimen will be HiDAC.