A Phase II Study of Single Agent Clofarabine in Previously Untreated Older Adult Patients With Acute Myelogenous Leukemia (AML) for Whom Standard Induction Chemotherapy is Unlikely to be of Benefit
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants Achieving Overall Remission (OR) After No More Than Two Cycles (Approximately Month 2)
Best response was assessed by the Independent Response Review Panel(IRRP) after two cycles of treatment. Overall remission(OR) is the sum of complete remission(CR) and complete remission in the absence of platelet recovery(CRp). CR includes normal values for peripheral blood cell counts (absolute neutrophil and platelet) and leukemic blast cells from bone marrow biopsy or aspirate, and absence of extramedullary disease. Partial remission(PR) includes recovery of peripheral blood cells with improved but still abnormal values in leukemic blast cells.
approximately Month 2
No
Medical Monitor
Study Director
Genzyme
United States: Food and Drug Administration
CLO24300606
NCT00373529
October 2006
May 2010
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Mount Sinai School of Medicine | New York, New York 10029 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Emory University School of Medicine | Atlanta, Georgia 30322 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Rocky Mountain Cancer Centers | Thornton, Colorado 80260 |
Medical College of Georgia | Augusta, Georgia 30912 |
Scripps Cancer Center | La Jolla, California 92037 |
Oregon Health and Science University | Portland, Oregon 97201 |
Penn State Hershey Medical Center | Hershey, Pennsylvania 17033 |
Cancer Care Centers of South Texas | San Antonio, Texas 78229 |
Mayo Clinical Hospital | Scottsdale, Arizona |
Cancer Center of Central Connecticut | Southington, Connecticut |
University of Utah - Huntsman Cancer Institute | Salt Lake City, Utah |
University of MD Anderson Cancer Center | Houston, Texas |
West Virginia University - HSC | Morgantown, West Virginia |