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Brief Title: Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia
Official Title: Phase III, Multicenter, Randomized, Trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients 60-75 Years of Age With Untreated High Risk (Secondary) AML
Study ID: NCT01696084
Brief Summary: To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint will be overall survival.
Detailed Description:
Minimum Age: 60 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
UCLA, Los Angeles, California, United States
University of CA San Diego, San Diego, California, United States
Stanford University, Stanford, California, United States
Yale University, New Haven, Connecticut, United States
University of Florida, Gainesville, Florida, United States
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
Northside Hospital, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Chicago, Chicago, Illinois, United States
Franciscan St. Francis Health, Indianapolis, Indiana, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
University of Missouri, Columbia, Missouri, United States
Washington University, Saint Louis, Missouri, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Montefiore Medical Center, Bronx, New York, United States
North Shore LIJ Health System, Long Island City, New York, United States
Columbia University, New York, New York, United States
Cornell U, Weill Medical College, New York, New York, United States
New York Medical College, Valhalla, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest University Health Services, Winston-Salem, North Carolina, United States
Providence Portland Medical Center, Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
UPMC, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Vanderbilt University, Nashville, Tennessee, United States
Baylor Research Insitute, Dallas, Texas, United States
M.D. Anderson Cancer Center, Houston, Texas, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
University of Alberta Hospital, Edmonton, Alberta, Canada
British Columbia Cancer Center, Vancouver, British Columbia, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada