Phase 2 Open-Label Study of Amonafide L-Malate in Combination With Cytarabine in Subjects With Secondary Acute Myeloid Leukemia (AML)
This is a two-stage, open-label, phase 2, multicenter study of amonafide L-malate in
combination with standard-dose cytarabine in subjects with secondary AML.
Amonafide is a DNA intercalating agent and inhibitor of topoisomerase II that has been
extensively studied in patients with malignant solid tumors. Amonafide has also been
studied in patients with AML. In three phase I clinical trials, amonafide demonstrated
anti-leukemic activity, both as monotherapy and in combination with cytarabine. This
protocol is designed to further assess the safety and efficacy of amonafide in combination
with cytarabine in subjects with previously untreated secondary AML.
The duration of the study is approximately 42 months: enrollment approximately 18 months and
subject duration up to 24 months
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- To determine the rate of complete remission with or without complete hematopoietic recovery (CR + CRi).
Steven Allen, MD
Principal Investigator
North Shore Hospital
United States: Food and Drug Administration
0001A3-200-GL
NCT00273884
August 2005
April 2009
Name | Location |
---|---|
University of Michigan | Ann Arbor, Michigan 48109-0624 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
University of Florida Health Science Center | Gainesville, Florida 32610-0296 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
City of Hope National Medical Center | Los Angeles, California 91010 |
Baylor University Medical Center | Dallas, Texas 75246 |
Duke University Medical Center | Durham, North Carolina 27710 |
Scripps Cancer Center | La Jolla, California 92037 |
UCLA Medical Center | Los Angeles, California 90095-7059 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
University of Colorado Health Sciences Center, Anschutz Cancer Center | Aurora, Colorado 80010 |
Northwestern University, Robert H. Lurie Comprehensive Cancer Center | Chicago, Illinois 60611 |
St. Francis Cancer Research Foundation (formerly Indiana Oncology Hematology Consultants and American Health Network of Indiana LLC, Oncology Division) | Indianapolis, Indiana 46202 |
MUSC - Hollings Cancer Center | Charleston, South Carolina 29425 |
West Virginia University Medical Center | Morgantown, West Virginia 26506-9162 |