Study of CEP-701 (Lestaurtinib) in Patients With Acute Myeloid Leukemia (AML)
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Drug: Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)
- Registration Number
- NCT00079482
- Lead Sponsor
- Cephalon
- Brief 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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 224
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 high-dose cytarabine 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. 1 CEP-701 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. 1 Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy) 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. 2 CEP-701 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.
- Primary Outcome Measures
Name Time Method Determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed AML who achieve a second complete remission or a complete remission with incomplete platelet count recovery. 113 days
- Secondary Outcome Measures
Name Time Method - overall survival - event-free survival - remission duration - safety and tolerability of CEP-701 - pharmacokinetics of CEP-701 - CEP-701 inhibitory activity 113 days
Trial Locations
- Locations (38)
Univeristy of Maryland Medicine - Greenebaum Cancer Center
🇺🇸Baltimore, Maryland, United States
Beth Israel Hospital
🇺🇸Boston, Massachusetts, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Alabama
🇺🇸Birmingham, Alabama, 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
Johns Hopkins
🇺🇸Baltimore, Maryland, 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
New York Presbyterian
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
CHA Hospital Enfant-Jesus
🇨🇦Quebec, Canada
Mayo-Scottsdale
🇺🇸Scottsdale, Arizona, United States
LSU Shreveport
🇺🇸Shreveport, Louisiana, United States
Tufts New England Medical Center
🇺🇸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
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Call for Information
🇦🇺Herston, Queensland, Australia
Call For Information
🇺🇦Lvov, Ukraine
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
ACORN-The West Clinic
🇺🇸Memphis, Tennessee, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
The Mayo Clinic
🇺🇸Rochester, Minnesota, United States