- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00301821
Monoclonal Antibody Therapy and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma
A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
Przegląd badań
Status
Warunki
Szczegółowy opis
OBJECTIVES:> Primary>
- Assess the efficacy of epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP), as measured by 12-month, event-free survival, in patients with previously untreated stage II, III, or IV diffuse large B-cell lymphoma.>
- Assess the use of positron emission tomography (PET) scan routinely early in treatment and after completion of treatment.>
- Assess the functional response rate (complete response, partial response, or stable disease by CT scan and PET negative) in patients treated with this regimen.>
- Assess the safety of this treatment regimen.> Secondary>
- Correlate laboratory prognostic factors for large cell lymphoma with clinical response to this regimen.> OUTLINE: This is a multicenter study.> Patients receive epratuzumab IV over 1 hour on day 1, rituximab IV over 4-8 hours on day 1 or days 1 and 2, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 or 2, and oral prednisone on days 1-5 or 2-6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.> After completion of study treatment, patients are followed periodically for up to 5 years.> PROJECTED ACCRUAL: A total of 86 patients will be accrued for this study.>
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
-
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Arizona
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Scottsdale, Arizona, Stany Zjednoczone, 85259-5499
- Mayo Clinic Scottsdale
-
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Colorado
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Aurora, Colorado, Stany Zjednoczone, 80012
- Aurora Presbyterian Hospital
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Boulder, Colorado, Stany Zjednoczone, 80301-9019
- Boulder Community Hospital
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Colorado Springs, Colorado, Stany Zjednoczone, 80933
- Penrose Cancer Center at Penrose Hospital
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Denver, Colorado, Stany Zjednoczone, 80210
- Porter Adventist Hospital
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Denver, Colorado, Stany Zjednoczone, 80220
- Rose Medical Center
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Denver, Colorado, Stany Zjednoczone, 80218
- Presbyterian - St. Luke's Medical Center
-
Denver, Colorado, Stany Zjednoczone, 80218
- St. Joseph Hospital
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Denver, Colorado, Stany Zjednoczone, 80224-2522
- CCOP - Colorado Cancer Research Program
-
Englewood, Colorado, Stany Zjednoczone, 80110
- Swedish Medical Center
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Fort Collins, Colorado, Stany Zjednoczone, 80524
- Front Range Cancer Specialists
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Grand Junction, Colorado, Stany Zjednoczone, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
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Lone Tree, Colorado, Stany Zjednoczone, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Stany Zjednoczone, 80502
- Hope Cancer Care Center at Longmont United Hospital
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Pueblo, Colorado, Stany Zjednoczone, 81004
- St. Mary - Corwin Regional Medical Center
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Thornton, Colorado, Stany Zjednoczone, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, Stany Zjednoczone, 80033
- Exempla Lutheran Medical Center
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Florida
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Jacksonville, Florida, Stany Zjednoczone, 32224
- Mayo Clinic - Jacksonville
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Illinois
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Aurora, Illinois, Stany Zjednoczone, 60507
- Rush-Copley Cancer Care Center
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Bloomington, Illinois, Stany Zjednoczone, 61701
- St. Joseph Medical Center
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Canton, Illinois, Stany Zjednoczone, 61520
- Graham Hospital
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Carthage, Illinois, Stany Zjednoczone, 62321
- Memorial Hospital
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Eureka, Illinois, Stany Zjednoczone, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Stany Zjednoczone, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, Stany Zjednoczone, 61401
- Galesburg Clinic
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Havana, Illinois, Stany Zjednoczone, 62644
- Mason District Hospital
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Hopedale, Illinois, Stany Zjednoczone, 61747
- Hopedale Medical Complex
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Joliet, Illinois, Stany Zjednoczone, 60435
- Joliet Oncology-Hematology Associates, Limited - West
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Kewanee, Illinois, Stany Zjednoczone, 61443
- Kewanee Hospital
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Macomb, Illinois, Stany Zjednoczone, 61455
- Mcdonough District Hospital
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Moline, Illinois, Stany Zjednoczone, 61265
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Moline, Illinois, Stany Zjednoczone, 61265
- Trinity Medical Center - East
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Normal, Illinois, Stany Zjednoczone, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Stany Zjednoczone, 61761
- Community Cancer Center
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Ottawa, Illinois, Stany Zjednoczone, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Stany Zjednoczone, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Stany Zjednoczone, 61554
- Cancer Treatment Center at Pekin Hospital
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Peoria, Illinois, Stany Zjednoczone, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Stany Zjednoczone, 61614
- Proctor Hospital
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Peoria, Illinois, Stany Zjednoczone, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Stany Zjednoczone, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Stany Zjednoczone, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Stany Zjednoczone, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Stany Zjednoczone, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, Stany Zjednoczone, 61362
- St. Margaret's Hospital
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Urbana, Illinois, Stany Zjednoczone, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, Stany Zjednoczone, 61801
- CCOP - Carle Cancer Center
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Indiana
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Beech Grove, Indiana, Stany Zjednoczone, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Michigan City, Indiana, Stany Zjednoczone, 46360
- Saint Anthony Memorial Health Centers
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Richmond, Indiana, Stany Zjednoczone, 47374
- Reid Hospital & Health Care Services, Incorporated
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Iowa
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Ames, Iowa, Stany Zjednoczone, 50010
- McFarland Clinic, PC
-
Des Moines, Iowa, Stany Zjednoczone, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Stany Zjednoczone, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Stany Zjednoczone, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Stany Zjednoczone, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Stany Zjednoczone, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Stany Zjednoczone, 50307
- Mercy Capitol Hospital
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Des Moines, Iowa, Stany Zjednoczone, 50316-2301
- John Stoddard Cancer Center
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Mason City, Iowa, Stany Zjednoczone, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Sioux City, Iowa, Stany Zjednoczone, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Stany Zjednoczone, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Stany Zjednoczone, 51104
- Mercy Medical Center - Sioux City
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Kansas
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Chanute, Kansas, Stany Zjednoczone, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Stany Zjednoczone, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Stany Zjednoczone, 67042
- Cancer Center of Kansas, PA - El Dorado
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Kingman, Kansas, Stany Zjednoczone, 67068
- Cancer Center of Kansas, PA - Kingman
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Liberal, Kansas, Stany Zjednoczone, 67901
- Southwest Medical Center
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Newton, Kansas, Stany Zjednoczone, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Stany Zjednoczone, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Stany Zjednoczone, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Stany Zjednoczone, 67042
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, Stany Zjednoczone, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Stany Zjednoczone, 67203
- Associates in Womens Health, PA - North Review
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Wichita, Kansas, Stany Zjednoczone, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Stany Zjednoczone, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Stany Zjednoczone, 67214
- CCOP - Wichita
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Wichita, Kansas, Stany Zjednoczone, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Winfield, Kansas, Stany Zjednoczone, 67156
- Cancer Center of Kansas, PA - Winfield
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Michigan
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Adrian, Michigan, Stany Zjednoczone, 49221
- Hickman Cancer Center at Bixby Medical Center
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Lambertville, Michigan, Stany Zjednoczone, 48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
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Monroe, Michigan, Stany Zjednoczone, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, Stany Zjednoczone, 48162
- Mercy Memorial Hospital - Monroe
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Minnesota
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Alexandria, Minnesota, Stany Zjednoczone, 56308
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Bemidji, Minnesota, Stany Zjednoczone, 56601
- MeritCare Bemidji
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Burnsville, Minnesota, Stany Zjednoczone, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Stany Zjednoczone, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Stany Zjednoczone, 55805
- CCOP - Duluth
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Duluth, Minnesota, Stany Zjednoczone, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Stany Zjednoczone, 55805
- Miller - Dwan Medical Center
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Edina, Minnesota, Stany Zjednoczone, 55435
- Fairview Southdale Hospital
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Fergus Falls, Minnesota, Stany Zjednoczone, 56537
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Fridley, Minnesota, Stany Zjednoczone, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Stany Zjednoczone, 55350
- Hutchinson Area Health Care
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Litchfield, Minnesota, Stany Zjednoczone, 55355
- Meeker County Memorial Hospital
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Maplewood, Minnesota, Stany Zjednoczone, 55109
- Minnesota Oncology Hematology, PA - Maplewood
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Maplewood, Minnesota, Stany Zjednoczone, 55109
- HealthEast Cancer Care at St. John's Hospital
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Minneapolis, Minnesota, Stany Zjednoczone, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, Stany Zjednoczone, 55415
- Hennepin County Medical Center - Minneapolis
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Montevideo, Minnesota, Stany Zjednoczone, 56265
- Chippewa County - Montevideo Hospital and Medical Center
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Robbinsdale, Minnesota, Stany Zjednoczone, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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Rochester, Minnesota, Stany Zjednoczone, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Stany Zjednoczone, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, Stany Zjednoczone, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, Stany Zjednoczone, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Stany Zjednoczone, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, Stany Zjednoczone, 55102
- United Hospital
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Saint Paul, Minnesota, Stany Zjednoczone, 55101
- Regions Hospital Cancer Care Center
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Saint Paul, Minnesota, Stany Zjednoczone, 55102
- HealthEast Cancer Care at St. Joseph's Hospital
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Shakopee, Minnesota, Stany Zjednoczone, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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Waconia, Minnesota, Stany Zjednoczone, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, Stany Zjednoczone, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Woodbury, Minnesota, Stany Zjednoczone, 55125
- HealthEast Cancer Care at Woodwinds Health Campus
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Nebraska
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Lincoln, Nebraska, Stany Zjednoczone, 68510
- Cancer Resource Center - Lincoln
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Omaha, Nebraska, Stany Zjednoczone, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Stany Zjednoczone, 68122
- Immanuel Medical Center
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Omaha, Nebraska, Stany Zjednoczone, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, Stany Zjednoczone, 68131-2197
- Creighton University Medical Center
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North Carolina
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Rutherfordton, North Carolina, Stany Zjednoczone, 28139
- Rutherford Hospital
-
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North Dakota
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Bismarck, North Dakota, Stany Zjednoczone, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, Stany Zjednoczone, 58501
- Medcenter One Hospital Cancer Care Center
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Bismarck, North Dakota, Stany Zjednoczone, 58501
- Mid Dakota Clinic, PC
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Bismarck, North Dakota, Stany Zjednoczone, 58502
- St. Alexius Medical Center Cancer Center
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Fargo, North Dakota, Stany Zjednoczone, 58122
- CCOP - MeritCare Hospital
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Fargo, North Dakota, Stany Zjednoczone, 58122
- MeritCare Broadway
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Ohio
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Bowling Green, Ohio, Stany Zjednoczone, 43402
- Wood County Oncology Center
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Dayton, Ohio, Stany Zjednoczone, 45428
- Veterans Affairs Medical Center - Dayton
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Dayton, Ohio, Stany Zjednoczone, 45405
- Grandview Hospital
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Dayton, Ohio, Stany Zjednoczone, 45406
- Good Samaritan Hospital
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Dayton, Ohio, Stany Zjednoczone, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
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Dayton, Ohio, Stany Zjednoczone, 45415
- Samaritan North Cancer Care Center
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Dayton, Ohio, Stany Zjednoczone, 45429
- CCOP - Dayton
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Findlay, Ohio, Stany Zjednoczone, 45840
- Blanchard Valley Medical Associates
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Fremont, Ohio, Stany Zjednoczone, 43420
- Fremont Memorial Hospital
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Kettering, Ohio, Stany Zjednoczone, 45429
- Charles F. Kettering Memorial Hospital
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Lima, Ohio, Stany Zjednoczone, 45804
- Lima Memorial Hospital
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Maumee, Ohio, Stany Zjednoczone, 43537
- Northwest Ohio Oncology Center
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Maumee, Ohio, Stany Zjednoczone, 43537
- St. Luke's Hospital
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Middletown, Ohio, Stany Zjednoczone, 45044
- Middletown Regional Hospital
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Oregon, Ohio, Stany Zjednoczone, 43616
- St. Charles Mercy Hospital
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Oregon, Ohio, Stany Zjednoczone, 43616
- Toledo Clinic - Oregon
-
Sandusky, Ohio, Stany Zjednoczone, 44870
- Firelands Regional Medical Center
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Sandusky, Ohio, Stany Zjednoczone, 44870
- North Coast Cancer Care, Incorporated
-
Sylvania, Ohio, Stany Zjednoczone, 43560
- Flower Hospital Cancer Center
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Tiffin, Ohio, Stany Zjednoczone, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, Stany Zjednoczone, 43608
- St. Vincent Mercy Medical Center
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Toledo, Ohio, Stany Zjednoczone, 43606
- Toledo Hospital
-
Toledo, Ohio, Stany Zjednoczone, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, Stany Zjednoczone, 43617
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, Stany Zjednoczone, 43623
- Toledo Clinic, Incorporated - Main Clinic
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Troy, Ohio, Stany Zjednoczone, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
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Wauseon, Ohio, Stany Zjednoczone, 43567
- Fulton County Health Center
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Xenia, Ohio, Stany Zjednoczone, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Oklahoma
-
Tulsa, Oklahoma, Stany Zjednoczone, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
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-
Pennsylvania
-
Allentown, Pennsylvania, Stany Zjednoczone, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
-
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South Carolina
-
Anderson, South Carolina, Stany Zjednoczone, 29621
- AnMed Cancer Center
-
Spartanburg, South Carolina, Stany Zjednoczone, 29303
- CCOP - Upstate Carolina
-
Spartanburg, South Carolina, Stany Zjednoczone, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
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South Dakota
-
Sioux Falls, South Dakota, Stany Zjednoczone, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, Stany Zjednoczone, 57105
- Medical X-Ray Center, PC
-
Sioux Falls, South Dakota, Stany Zjednoczone, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Virginia
-
Fredericksburg, Virginia, Stany Zjednoczone, 22401
- Hematology-Oncology Associates of Fredericksburg, Incorporated
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Wisconsin
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La Crosse, Wisconsin, Stany Zjednoczone, 54601
- Franciscan Skemp Healthcare - La Crosse Campus
-
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
DISEASE CHARACTERISTICS:
Histologically confirmed diffuse large B-cell lymphoma
- B-cell phenotype (CD20+) as determined by immunohistochemistry (IHC) or flow cytometry
- Stage II, III, or IV disease
- CD22+ tumor by IHC*
NOTE: *CD22 status may be determined after study enrollment
- Measurable disease, defined as at least 1 lesion ≥ 1.5 cm by CT scan or physical exam
- No relapsed or refractory non-Hodgkin's lymphoma
- No history of transformed lymphoma
No CNS lymphoma
- CNS symptoms or bone marrow or sinus involvement must have absence of CNS lymphoma confirmed by lumbar puncture
PATIENT CHARACTERISTICS:
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3
- For patients with ECOG PS 3, the PS must be disease related
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Total bilirubin ≤ 2 mg/dL (if total bilirubin > 2 mg/dL, direct bilirubin should be within normal limits)
- AST ≤ 3 times upper limit of normal (ULN) (5 times ULN if there is liver involvement)
- Creatinine ≤ 2 times ULN
- Life expectancy ≥ 12 weeks
- Negative pregnancy test
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 12 months after completion of study treatment
- No active serious infection requiring antibiotics
- No New York Heart Association class III or IV heart disease
- No other primary malignancy within the past 5 years, except for squamous cell or basal cell carcinoma of the skin, in situ carcinoma of the cervix, or previously treated prostate cancer with a stable prostate-specific antigen
- No known HIV positivity
- No known hepatitis B or C infection
- Ejection fraction ≥ 45% by MUGA or echocardiogram (required if patients has a history of heart disease or is ≥ 50 years old)
- Willing to provide blood and tissue samples for mandatory translational research component of study
PRIOR CONCURRENT THERAPY:
No prior therapy for diffuse large B-cell lymphoma, including the following:
- Chemotherapy
- Immunotherapy
- Biologic therapy
- Radiotherapy
- Prior short course (≤ 14 days) of corticosteroids allowed
- Prior splenectomy allowed
- No prior pelvic irradiation
- No other concurrent investigational agents
- No concurrent chemotherapy, immunotherapy, or radiotherapy
- No concurrent enrollment on another treatment study involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy, or gene therapy)
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: Epratuzumab + Rituximab + CHOP
One arm open label.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Event-free Survival After 12 Months
Ramy czasowe: From Baseline to 12 months
|
The primary endpoint of the trial was the percentage of the eligible patients who were alive and event-free 12 months after enrollment to the study (EFS12).
|
From Baseline to 12 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Overall Survival
Ramy czasowe: time from study entry to 36 months
|
Percentage of participants alive at different time points
|
time from study entry to 36 months
|
Progression-free Survival (PFS)
Ramy czasowe: the time from study entry to 36 months
|
Percentage of participants Progression-free at different time points.
Response was assessed using International Workshop Response Criteria.38
Response is based on CT alone.
Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.
|
the time from study entry to 36 months
|
Overall Response Rate (ORR)
Ramy czasowe: Baseline to first 6 cycles of treatment
|
Overall response rate will be estimated by the number of patients with objective status of partial response (PR), unconfirmed complete response (CRu), or complete response (CR) during the first 6 cycles of treatment divided by number of evaluable patients (met eligibility criteria, signed consent form, and started treatment).
Response was assessed using International Workshop Response Criteria.38
Response is based on CT alone.
Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.
|
Baseline to first 6 cycles of treatment
|
Współpracownicy i badacze
Współpracownicy
Śledczy
- Krzesło do nauki: Ivana Micallef, MD, Mayo Clinic
Publikacje i pomocne linki
Publikacje ogólne
- Ghesquieres H, Larrabee BR, Haioun C, Link BK, Verney A, Slager SL, Ketterer N, Ansell SM, Delarue R, Maurer MJ, Fitoussi O, Habermann TM, Peyrade F, Dogan A, Molina TJ, Novak AJ, Tilly H, Cerhan JR, Salles G. FCGR3A/2A polymorphisms and diffuse large B-cell lymphoma outcome treated with immunochemotherapy: a meta-analysis on 1134 patients from two prospective cohorts. Hematol Oncol. 2017 Dec;35(4):447-455. doi: 10.1002/hon.2305. Epub 2016 Jun 10.
- Micallef IN, Kahl BS, Maurer MJ, Dogan A, Ansell SM, Colgan JP, Geyer S, Inwards DJ, White WL, Habermann TM. A pilot study of epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy in patients with previously untreated, diffuse large B-cell lymphoma. Cancer. 2006 Dec 15;107(12):2826-32. doi: 10.1002/cncr.22342.
- Maurer MJ, Micallef IN, Cerhan JR, Katzmann JA, Link BK, Colgan JP, Habermann TM, Inwards DJ, Markovic SN, Ansell SM, Porrata LF, Johnston PB, Nowakowski GS, Thompson CA, Gupta M, Syrbu SI, Kurtin PJ, Macon WR, Nikcevich DA, Witzig TE. Elevated serum free light chains are associated with event-free and overall survival in two independent cohorts of patients with diffuse large B-cell lymphoma. J Clin Oncol. 2011 Apr 20;29(12):1620-6. doi: 10.1200/JCO.2010.29.4413. Epub 2011 Mar 7.
- Micallef IN, Maurer MJ, Wiseman GA, Nikcevich DA, Kurtin PJ, Cannon MW, Perez DG, Soori GS, Link BK, Habermann TM, Witzig TE. Epratuzumab with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy in patients with previously untreated diffuse large B-cell lymphoma. Blood. 2011 Oct 13;118(15):4053-61. doi: 10.1182/blood-2011-02-336990. Epub 2011 Jun 14.
- Micallef IN, Maurer MJ, Nikcevich DA, et al.: Final results of NCCTG N0489: epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy (ER-CHOP) in patients with previously untreated diffuse large B-cell lymphoma. [Abstract] J Clin Oncol 27 (Suppl 15): A-8508, 2009.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby układu odpornościowego
- Nowotwory według typu histologicznego
- Nowotwory
- Zaburzenia limfoproliferacyjne
- Choroby limfatyczne
- Zaburzenia immunoproliferacyjne
- Chłoniak nieziarniczy
- Chłoniak z komórek B
- Chłoniak
- Chłoniak, duże komórki B, rozlany
- Fizjologiczne skutki leków
- Molekularne mechanizmy działania farmakologicznego
- Inhibitory enzymów
- Środki przeciwzapalne
- Środki przeciwreumatyczne
- Środki przeciwnowotworowe
- Środki immunosupresyjne
- Czynniki immunologiczne
- Modulatory tubuliny
- Środki antymitotyczne
- Modulatory mitozy
- Glikokortykosteroidy
- Hormony
- Hormony, substytuty hormonów i antagoniści hormonów
- Środki przeciwnowotworowe, hormonalne
- Środki przeciwnowotworowe, alkilujące
- Środki alkilujące
- Agoniści mieloablacyjni
- Środki przeciwnowotworowe, Fitogenne
- Inhibitory topoizomerazy II
- Inhibitory topoizomerazy
- Środki przeciwnowotworowe, immunologiczne
- Antybiotyki, Przeciwnowotworowe
- Cyklofosfamid
- Epratuzumab
- Rytuksymab
- Prednizon
- Doksorubicyna
- Liposomalna doksorubicyna
- Winkrystyna
Inne numery identyfikacyjne badania
- NCCTG-N0489
- NCI-2012-02685 (Identyfikator rejestru: CTRP (Clinical Trials Reporting System))
- CDR0000459932 (Identyfikator rejestru: PDQ (Physician Data Query))
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Badania kliniczne na Chłoniak
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Gilead SciencesZakończonyChłoniak grudkowy | Chłoniak z komórek płaszcza | Przewlekła białaczka limfocytowa | Rozlany chłoniak z dużych komórek B | Non-FL Indolent Non-Hodgkin's LymphomaStany Zjednoczone, Kanada