Phase III Open-Label Randomized Study of Amonafide L-Malate in Combination With Cytarabine Compared to Daunorubicin in Combination With Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- The ACCEDE Study
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of CR + CRi (which includes CRc and CRd) will be determined by assessing the proportion of patients who achieved CR or CRi among all evaluable patients.
Course 1/Course 2 Day 37 bone marrow assessments and confirmation bone marrow 30 days later
No
United States: Food and Drug Administration
509912
NCT00715637
June 2007
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Michigan State University | East Lansing, Michigan 48824 |
Roger Williams Medical Center | Providence, Rhode Island 02908-4735 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Oregon Health & Science University | Portland, Oregon 97201 |
Duke University Medical Center | Durham, North Carolina 27710 |
University of California San Francisco | San Francisco, California 941104206 |
University of Colorado Health Sciences Center | Denver, Colorado 80262 |
UCLA Medical Center | Los Angeles, California 90095-7059 |
University of Michigan Cancer Center | Ann Arbor, Michigan 48109 |
Thomas Jefferson University | Philadelphia, Pennsylvania 19107-6541 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Penn State Hershey Medical Center | Hershey, Pennsylvania 17033 |
Cancer Center of the Carolinas | Greenville, South Carolina 29615 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
Winship Cancer Institute, Emory University | Atlanta, Georgia 30322 |
Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
Rocky Mountain Blood and Marrow Transplant Program | Denver, Colorado 80218 |
Northwestern University School of Medicine | Chicago, Illinois 60611 |
LSU Health Sciences Center, Feist-Weiller Cancer Center | Shreveport, Louisiana 71130 |
Univ of Southern California Comprehensive Cancer Center | Los Angeles, California 90033 |
The Blood and Marrow Transplant Group of GA | Atlanta, Georgia 30342 |
University of Iowa Hospitals | Iowa City, Iowa 52242 |
Northshore Hospital - Monter Cancer Center | Lake Success, New York 11042 |
Taussig Cancer Center, Cleveland Clinic | Cleveland, Ohio 44195 |
Intermountain Healthcare | Salt Lake City, Utah 84103 |