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Brief Title: A Trial in Patients With Diffuse Large-B-cell Lymphoma Comparing Pixantrone Against Doxorubicin
Official Title: Cyclophosphamide, Doxorubicin, Vincristine, Prednisone Plus Rituximab (CHOP-R) and Cyclophosphamide, Pixantrone, Vincristine, Prednisone Plus Rituximab (CPOP-R) in Patients With Diffuse Large-B-cell Lymphoma: A Phase II, Randomized, Multicenter, Comparative Trial
Study ID: NCT00268853
Brief Summary: The purpose of this study is to compare the standard CHOP-R regimen of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Rituximab to CPOP-R (same regimen, but substituting Doxorubicin with Pixantrone). The objective is to show that CPOP-R is not inferior to CHOP-R.
Detailed Description: In preclinical studies, pixantrone has shown significantly less cardiotoxicity than other anthracyclines or anthracenediones. In addition, patients with relapsed disease, who have received prior maximum doses of anthracyclines, have tolerated high doses of pixantrone with minimal added cardiotoxicity. Pixantrone is currently being studied in a Phase III study in 3rd line aggressive NHL.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Bay Medical Oncology & Hematology, Concord, California, United States
Hazel Hawkins Hospital, Dept. of Medical Oncology, Hollister, California, United States
UCSD Moore's Cancer Center-Blood & Marrow Transplantation Division, La Jolla, California, United States
Loma Linda University Medical Center, Loma Linda, California, United States
Hematology/Oncology Group of Orange County, Orange, California, United States
Sharp Memorial Hospital, San Diego, California, United States
Rocky Mountain Cancer Center, Denver, Colorado, United States
The Center of Hematology and Oncology, Boca Raton, Florida, United States
Broward Oncology Associates, Fort Lauderdale, Florida, United States
Osceola Cancer Center, Kissimmee, Florida, United States
Watson Clinic for Cancer Care and Research, Lakeland, Florida, United States
Watson Clinic, Lakeland, Florida, United States
Memorial Cancer Institute, Pembroke Pines, Florida, United States
Hematology Oncology Associates of the Treasure Coast, Port Saint Lucie, Florida, United States
Oncology Hematology Associates of West Broward, Tamarac, Florida, United States
Hematology Oncology Specialists, Tampa, Florida, United States
John B. Amos Cancer Center, Columbus, Georgia, United States
Columbus Clinic, Columbus, Georgia, United States
Oncology Hematology of Northern Illinois, Gurnee, Illinois, United States
Mid-Illinois Hematology & Oncology Associates, Normal, Illinois, United States
Cancer Care Center, New Albany, Indiana, United States
Consultants in Blood Disorders and Cancer, Louisville, Kentucky, United States
Western Kentucky Hematology/Oncology Group, Paducah, Kentucky, United States
Our Lady of the Lake Regional Medial Center, Hematology Oncology, Baton Rouge, Louisiana, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Maryland Hematology/Oncology Associates, PA, Baltimore, Maryland, United States
Center for Cancer and Blood Disorders, P.C., Bethesda, Maryland, United States
Frederick Memorial Hospital Cancer Center, Frederick, Maryland, United States
Tufts-New England Medical Center-The Neely Ctr for Clinical Cancer Research, Boston, Massachusetts, United States
Hubert H Humphrey Cancer Center, Robbinsdale, Minnesota, United States
North Missssppi Hematology Oncology Associates, Tupelo, Mississippi, United States
Capital Comprehensive Cancer Care, Jefferson City, Missouri, United States
Southeast Nebraska Hematology and Oncology Consultants, P.C., Lincoln, Nebraska, United States
Nevada Cancer Institute, Las Vegas, Nevada, United States
New Mexico Hematology/Oncology Consultants, Albuquerque, New Mexico, United States
Jacobi Medical Center Phase I Oncology, Bronx, New York, United States
Our Lady of Mercy Medical Center, Bronx, New York, United States
St. Luke's Roosevelt Hospital, New York, New York, United States
Interlake Foundation, Inc., Rochester, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Brody School of Medicine at East Carolina University - Leo W. Jenkins Cancer Center, Greenville, North Carolina, United States
Cancer Treatment & Research Mid-Dakota Clinic, Bismarck, North Dakota, United States
Summa Health Systems Hospitals, Akron, Ohio, United States
Barberton Citizen's Hospital, Barberton, Ohio, United States
Oncology Partners Network, Cincinnati, Ohio, United States
Dayton Clinical Oncology Program, Dayton, Ohio, United States
Northwest Kaiser Permanente, Portland, Oregon, United States
Berks Hematology-Oncology Associates Ltd., Reading, Pennsylvania, United States
Charleston Cancer Center, Charleston, South Carolina, United States
Low County Hematology & Oncology, Mount Pleasant, South Carolina, United States
The Family Cancer Center, Collierville, Tennessee, United States
Thompson Cancer Survival Center, Knoxville, Tennessee, United States
Sarah Cannon Cancer Center, Nashville, Tennessee, United States
Southwest Regional Cancer Center, Austin, Texas, United States
Texas Hematology Oncology Center, Dallas, Texas, United States
The Center for Cancer and Blood Disorders, Fort Worth, Texas, United States
Northern Utah Hematology Oncology, P.C., Ogden, Utah, United States
Multicare Oncology Hematology Specialists, Tacoma, Washington, United States
London Health Science Center Regional Care Program, London, Ontario, Canada
The Ottawa Hospital, Ottawa, Ontario, Canada
Queen Elizabeth II HSC, Halifax, , Canada
CHU Hotel Dieu, Nantes, , France
Hopitaux Universitaires de Strabourg - Hopital Hautepierre, Strasbourg, , France
Universitaetsklinikum Carl Gustav Carus, Dresden, , Germany
Universitaetsklinikum Duesseldorf, Duesseldorf, , Germany
Klinikum der Universitaet zu Koeln, Koeln, , Germany
Klinikum Nurnberg Nord - Medizinische, Nuernberg, , Germany
Universitaetsklinikum Wuerzburg, Wuerzburg, , Germany
Instituto di Ematologia "Lorenzo e Ariosto", Bologna, , Italy
Azienda Ospedaliera Careggi, Firenze, , Italy
Farmacia Osepdaliera, Odpedale Umberto I, Mestre, , Italy
Ospedal V. Cervello, Palermo, , Italy
Uiversita La Sapienza, Roma, , Italy
Policlinico S. Maria alle Scotte, Siena, , Italy
Ospedale Civile, Udine, , Italy
Name: Gabor Jurida, M.D.
Affiliation: CTI BioPharma
Role: STUDY_DIRECTOR