PHASE IIB, MULTICENTER, RANDOMIZED, OPEN LABEL TRIAL OF CPX-351 (CYTARABINE:DAUNORUBICIN) LIPOSOME INJECTION VERSUS CYTARABINE AND DAUNORUBICIN IN PATIENTS WITH UNTREATED AML 60-75 YEARS OF AGE.
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 standard induction
treatment with cytarabine and daunorubicin("7 and 3" regimen).
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
Complete Remission Rate
Following 1st induction, following 2nd induction if applicable
No
Jeffrey E Lancet, MD
Principal Investigator
H. Lee Moffitt Cancer Center
United States: Food and Drug Administration
CLTR0308-204
NCT00788892
October 2008
December 2011
Name | Location |
---|---|
Cedars Sinai Medical Center | Los Angeles, California 90048-1804 |
Arizona Cancer Center | Tucson, Arizona 85724 |
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
North Shore University Hospital | Manhasset, New York 11030 |
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
Joe Arrington Cancer Center | Lubbock, Texas 79410 |
Blood and Marrow Transplant Group of Georgia | Atlanta, Georgia 30342-1601 |
UC Davis Cancer Center | Sacramento, California 95817 |
Northern New Jersey Cancer Associates | Hackensack, New Jersey 07601 |
Oregon Health and Science University | Portland, Oregon 97201 |
Jewish Hospital | Cincinnati, Ohio 45236 |
Shands Jacksonville Medical Center | Jacksonville, Florida 32209 |
Texas Tech University Health Sciences Center | Lubbock, Texas 79430 |
University of California Medical Center | San Francisco, California 94143 |
H Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Robert H.Lurie Comprehensive Cancer Center | Chicago, Illinois 60611 |
St.Francis Hospital | Beech Grove, Indiana 46107 |
Weil Cornell Medical Center | New York, New York 10021 |
New York Medical College, Division of Oncology | Valhalla, New York 10595 |
Blumenthal Cancer Center/Mecklenburg Medical Group | Charlotte, North Carolina 28204 |
University of Pittsburg Cancer Center | Pittsburg, Pennsylvania 15232 |
Cancer Therapy and Research Center at the University of Texas | San Antonio, Texas 78229 |
Froedlert Hospital/Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |