Phase IIB, Multicenter, Randomized, Open-Label Trial Of CPX-351 (Cytarabine : Daunorubicin) Liposome Injection Versus Intensive Salvage Therapy In Adult Patients ≤ 65 Years Old With AML In First Relapse Following An Initial CR > 1 Month Duration
This study is a randomized, open-label, parallel-arm, fixed-dose, standard therapy
controlled Phase IIB trial. Study enrollment duration is expected to be approximately 12-18
months. On entry, patients are randomized to receive either CPX-351 or intensive first
salvage treatment.
Patients are stratified to balance the likelihood of obtaining a CR and the duration of CR
between the two arms.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage Overall Survival at 1 year
Up to 1 year from randomization
No
Jonathan Kolitz, MD
Principal Investigator
North Shore University Hospital
United States: Food and Drug Administration
CLTR0308-205
NCT00822094
February 2009
January 2012
Name | Location |
---|---|
Cedars Sinai Medical Center | Los Angeles, California 90048-1804 |
Johns Hopkins University | Baltimore, Maryland 21205 |
Arizona Cancer Center | Tucson, Arizona 85724 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
New York Medical College | Valhalla, New York 10595 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
Joe Arrington Cancer Center | Lubbock, Texas 79410 |
M.D. Anderson Cancer Center | Houston, Texas 77030 |
UCLA | Los Angeles, California 90095 |
UC Davis Cancer Center | Sacramento, California 95817 |
Oregon Health and Science University | Portland, Oregon 97201 |
St. Louis University Medical Center | St. Louis, Missouri |
Texas Tech University Health Sciences Center | Lubbock, Texas 79430 |
Northwestern University Robert H. Lurie Comprehensive Cancer Center | Chicago, Illinois 60611-2941 |
University of Chicago Medical Center Section of Hematology/Oncology | Chicago, Illinois 60546 |
St. Francis Cancer Center | Indianapolis, Indiana 46237 |
Weil Cornell Medical Center | New York, New York 10021 |
Blumenthal Cancer Center/Mecklenburg Medical Group | Charlotte, North Carolina 28204 |
University of Louisville Brown Cancer Center | Louisville, Kentucky 40202 |
Maine General Medical Center Harold Alfond Center for Cancer Care | Waterville, Maine 04901 |
The Cancer Center, Hackensack University Medical Center | Hackensack, New Jersey 07601 |
North Shore LIJ Center for Advanced Medicine Monter Cancer Center | Lake Success, New York 11042 |
Jewish Hospital of Cincinatti | Cincinatti, Ohio |
Oncology and Hematology at Lehigh Valley | Bethlehem, Pennsylvania 18105 |
UTMB Comprehensive Cancer Center | Galveston, Texas 77555 |
Cancer Therapy and Research Center at The University of TX Health Science Center | San Antonio, Texas 78229 |
Intermountain LDS Hospital | Salt Lake City, Utah 84143 |