Monoclonal Antibody Therapy and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma
1 de octubre de 2019 actualizado por: Alliance for Clinical Trials in Oncology
A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth in different ways.
Some block the ability of cancer cells to grow and spread.
Others find cancer cells and help kill them or carry cancer-killing substances to them.
Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells.>
PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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.>
Tipo de estudio
Intervencionista
Inscripción (Actual)
107
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85259-5499
- Mayo Clinic Scottsdale
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Colorado
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Aurora, Colorado, Estados Unidos, 80012
- Aurora Presbyterian Hospital
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Boulder, Colorado, Estados Unidos, 80301-9019
- Boulder Community Hospital
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Colorado Springs, Colorado, Estados Unidos, 80933
- Penrose Cancer Center at Penrose Hospital
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Denver, Colorado, Estados Unidos, 80210
- Porter Adventist Hospital
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Denver, Colorado, Estados Unidos, 80220
- Rose Medical Center
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Denver, Colorado, Estados Unidos, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Estados Unidos, 80218
- St. Joseph Hospital
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Denver, Colorado, Estados Unidos, 80224-2522
- CCOP - Colorado Cancer Research Program
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Englewood, Colorado, Estados Unidos, 80110
- Swedish Medical Center
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Fort Collins, Colorado, Estados Unidos, 80524
- Front Range Cancer Specialists
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Grand Junction, Colorado, Estados Unidos, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
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Lone Tree, Colorado, Estados Unidos, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Estados Unidos, 80502
- Hope Cancer Care Center at Longmont United Hospital
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Pueblo, Colorado, Estados Unidos, 81004
- St. Mary - Corwin Regional Medical Center
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Thornton, Colorado, Estados Unidos, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, Estados Unidos, 80033
- Exempla Lutheran Medical Center
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Florida
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Jacksonville, Florida, Estados Unidos, 32224
- Mayo Clinic - Jacksonville
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Illinois
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Aurora, Illinois, Estados Unidos, 60507
- Rush-Copley Cancer Care Center
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Bloomington, Illinois, Estados Unidos, 61701
- St. Joseph Medical Center
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Canton, Illinois, Estados Unidos, 61520
- Graham Hospital
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Carthage, Illinois, Estados Unidos, 62321
- Memorial Hospital
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Eureka, Illinois, Estados Unidos, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Estados Unidos, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, Estados Unidos, 61401
- Galesburg Clinic
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Havana, Illinois, Estados Unidos, 62644
- Mason District Hospital
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Hopedale, Illinois, Estados Unidos, 61747
- Hopedale Medical Complex
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Joliet, Illinois, Estados Unidos, 60435
- Joliet Oncology-Hematology Associates, Limited - West
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Kewanee, Illinois, Estados Unidos, 61443
- Kewanee Hospital
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Macomb, Illinois, Estados Unidos, 61455
- Mcdonough District Hospital
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Moline, Illinois, Estados Unidos, 61265
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Moline, Illinois, Estados Unidos, 61265
- Trinity Medical Center - East
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Normal, Illinois, Estados Unidos, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Estados Unidos, 61761
- Community Cancer Center
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Ottawa, Illinois, Estados Unidos, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Estados Unidos, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Estados Unidos, 61554
- Cancer Treatment Center at Pekin Hospital
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Peoria, Illinois, Estados Unidos, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Estados Unidos, 61614
- Proctor Hospital
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Peoria, Illinois, Estados Unidos, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Estados Unidos, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Estados Unidos, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Estados Unidos, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Estados Unidos, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, Estados Unidos, 61362
- St. Margaret's Hospital
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Urbana, Illinois, Estados Unidos, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, Estados Unidos, 61801
- CCOP - Carle Cancer Center
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Indiana
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Beech Grove, Indiana, Estados Unidos, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Michigan City, Indiana, Estados Unidos, 46360
- Saint Anthony Memorial Health Centers
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Richmond, Indiana, Estados Unidos, 47374
- Reid Hospital & Health Care Services, Incorporated
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Iowa
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Ames, Iowa, Estados Unidos, 50010
- McFarland Clinic, PC
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Des Moines, Iowa, Estados Unidos, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Estados Unidos, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Estados Unidos, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Estados Unidos, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Estados Unidos, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Estados Unidos, 50307
- Mercy Capitol Hospital
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Des Moines, Iowa, Estados Unidos, 50316-2301
- John Stoddard Cancer Center
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Mason City, Iowa, Estados Unidos, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Sioux City, Iowa, Estados Unidos, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Estados Unidos, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Estados Unidos, 51104
- Mercy Medical Center - Sioux City
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Kansas
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Chanute, Kansas, Estados Unidos, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Estados Unidos, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Estados Unidos, 67042
- Cancer Center of Kansas, PA - El Dorado
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Kingman, Kansas, Estados Unidos, 67068
- Cancer Center of Kansas, PA - Kingman
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Liberal, Kansas, Estados Unidos, 67901
- Southwest Medical Center
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Newton, Kansas, Estados Unidos, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Estados Unidos, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Estados Unidos, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Estados Unidos, 67042
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, Estados Unidos, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Estados Unidos, 67203
- Associates in Womens Health, PA - North Review
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Wichita, Kansas, Estados Unidos, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Estados Unidos, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Estados Unidos, 67214
- CCOP - Wichita
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Wichita, Kansas, Estados Unidos, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Winfield, Kansas, Estados Unidos, 67156
- Cancer Center of Kansas, PA - Winfield
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Michigan
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Adrian, Michigan, Estados Unidos, 49221
- Hickman Cancer Center at Bixby Medical Center
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Lambertville, Michigan, Estados Unidos, 48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
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Monroe, Michigan, Estados Unidos, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, Estados Unidos, 48162
- Mercy Memorial Hospital - Monroe
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Minnesota
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Alexandria, Minnesota, Estados Unidos, 56308
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Bemidji, Minnesota, Estados Unidos, 56601
- MeritCare Bemidji
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Burnsville, Minnesota, Estados Unidos, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Estados Unidos, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Estados Unidos, 55805
- CCOP - Duluth
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Duluth, Minnesota, Estados Unidos, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Estados Unidos, 55805
- Miller - Dwan Medical Center
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Edina, Minnesota, Estados Unidos, 55435
- Fairview Southdale Hospital
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Fergus Falls, Minnesota, Estados Unidos, 56537
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Fridley, Minnesota, Estados Unidos, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Estados Unidos, 55350
- Hutchinson Area Health Care
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Litchfield, Minnesota, Estados Unidos, 55355
- Meeker County Memorial Hospital
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Maplewood, Minnesota, Estados Unidos, 55109
- Minnesota Oncology Hematology, PA - Maplewood
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Maplewood, Minnesota, Estados Unidos, 55109
- HealthEast Cancer Care at St. John's Hospital
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Minneapolis, Minnesota, Estados Unidos, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, Estados Unidos, 55415
- Hennepin County Medical Center - Minneapolis
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Montevideo, Minnesota, Estados Unidos, 56265
- Chippewa County - Montevideo Hospital and Medical Center
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Robbinsdale, Minnesota, Estados Unidos, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Estados Unidos, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, Estados Unidos, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, Estados Unidos, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Estados Unidos, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, Estados Unidos, 55102
- United Hospital
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Saint Paul, Minnesota, Estados Unidos, 55101
- Regions Hospital Cancer Care Center
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Saint Paul, Minnesota, Estados Unidos, 55102
- HealthEast Cancer Care at St. Joseph's Hospital
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Shakopee, Minnesota, Estados Unidos, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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Waconia, Minnesota, Estados Unidos, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, Estados Unidos, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Woodbury, Minnesota, Estados Unidos, 55125
- HealthEast Cancer Care at Woodwinds Health Campus
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Nebraska
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Lincoln, Nebraska, Estados Unidos, 68510
- Cancer Resource Center - Lincoln
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Omaha, Nebraska, Estados Unidos, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Estados Unidos, 68122
- Immanuel Medical Center
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Omaha, Nebraska, Estados Unidos, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, Estados Unidos, 68131-2197
- Creighton University Medical Center
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North Carolina
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Rutherfordton, North Carolina, Estados Unidos, 28139
- Rutherford Hospital
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North Dakota
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Bismarck, North Dakota, Estados Unidos, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, Estados Unidos, 58501
- Medcenter One Hospital Cancer Care Center
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Bismarck, North Dakota, Estados Unidos, 58501
- Mid Dakota Clinic, PC
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Bismarck, North Dakota, Estados Unidos, 58502
- St. Alexius Medical Center Cancer Center
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Fargo, North Dakota, Estados Unidos, 58122
- CCOP - MeritCare Hospital
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Fargo, North Dakota, Estados Unidos, 58122
- MeritCare Broadway
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Ohio
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Bowling Green, Ohio, Estados Unidos, 43402
- Wood County Oncology Center
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Dayton, Ohio, Estados Unidos, 45428
- Veterans Affairs Medical Center - Dayton
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Dayton, Ohio, Estados Unidos, 45405
- Grandview Hospital
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Dayton, Ohio, Estados Unidos, 45406
- Good Samaritan Hospital
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Dayton, Ohio, Estados Unidos, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
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Dayton, Ohio, Estados Unidos, 45415
- Samaritan North Cancer Care Center
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Dayton, Ohio, Estados Unidos, 45429
- CCOP - Dayton
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Findlay, Ohio, Estados Unidos, 45840
- Blanchard Valley Medical Associates
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Fremont, Ohio, Estados Unidos, 43420
- Fremont Memorial Hospital
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Kettering, Ohio, Estados Unidos, 45429
- Charles F. Kettering Memorial Hospital
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Lima, Ohio, Estados Unidos, 45804
- Lima Memorial Hospital
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Maumee, Ohio, Estados Unidos, 43537
- Northwest Ohio Oncology Center
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Maumee, Ohio, Estados Unidos, 43537
- St. Luke's Hospital
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Middletown, Ohio, Estados Unidos, 45044
- Middletown Regional Hospital
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Oregon, Ohio, Estados Unidos, 43616
- St. Charles Mercy Hospital
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Oregon, Ohio, Estados Unidos, 43616
- Toledo Clinic - Oregon
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Sandusky, Ohio, Estados Unidos, 44870
- Firelands Regional Medical Center
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Sandusky, Ohio, Estados Unidos, 44870
- North Coast Cancer Care, Incorporated
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Sylvania, Ohio, Estados Unidos, 43560
- Flower Hospital Cancer Center
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Tiffin, Ohio, Estados Unidos, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, Estados Unidos, 43608
- St. Vincent Mercy Medical Center
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Toledo, Ohio, Estados Unidos, 43606
- Toledo Hospital
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Toledo, Ohio, Estados Unidos, 43614
- Medical University of Ohio Cancer Center
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Toledo, Ohio, Estados Unidos, 43617
- CCOP - Toledo Community Hospital
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Toledo, Ohio, Estados Unidos, 43623
- Toledo Clinic, Incorporated - Main Clinic
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Troy, Ohio, Estados Unidos, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
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Wauseon, Ohio, Estados Unidos, 43567
- Fulton County Health Center
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Xenia, Ohio, Estados Unidos, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
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Pennsylvania
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Allentown, Pennsylvania, Estados Unidos, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
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South Carolina
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Anderson, South Carolina, Estados Unidos, 29621
- AnMed Cancer Center
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Spartanburg, South Carolina, Estados Unidos, 29303
- CCOP - Upstate Carolina
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Spartanburg, South Carolina, Estados Unidos, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, Estados Unidos, 57105
- Medical X-Ray Center, PC
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Sioux Falls, South Dakota, Estados Unidos, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Virginia
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Fredericksburg, Virginia, Estados Unidos, 22401
- Hematology-Oncology Associates of Fredericksburg, Incorporated
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Wisconsin
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La Crosse, Wisconsin, Estados Unidos, 54601
- Franciscan Skemp Healthcare - La Crosse Campus
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Epratuzumab + Rituximab + CHOP
One arm open label.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Event-free Survival After 12 Months
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall Survival
Periodo de tiempo: time from study entry to 36 months
|
Percentage of participants alive at different time points
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time from study entry to 36 months
|
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Progression-free Survival (PFS)
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Ivana Micallef, MD, Mayo Clinic
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2006
Finalización primaria (Actual)
1 de octubre de 2008
Finalización del estudio (Actual)
1 de abril de 2015
Fechas de registro del estudio
Enviado por primera vez
9 de marzo de 2006
Primero enviado que cumplió con los criterios de control de calidad
9 de marzo de 2006
Publicado por primera vez (Estimar)
13 de marzo de 2006
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de octubre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
1 de octubre de 2019
Última verificación
1 de octubre de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Linfoma No Hodgkin
- Linfoma de células B
- Linfoma
- Linfoma de células B grandes, difuso
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antiinflamatorios
- Agentes antirreumáticos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Glucocorticoides
- Hormonas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Agentes Antineoplásicos Hormonales
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Agonistas mieloablativos
- Agentes antineoplásicos, fitogénicos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Agentes antineoplásicos inmunológicos
- Antibióticos, Antineoplásicos
- Ciclofosfamida
- Epratuzumab
- Rituximab
- Prednisona
- Doxorrubicina
- Doxorrubicina liposomal
- Vincristina
Otros números de identificación del estudio
- NCCTG-N0489
- NCI-2012-02685 (Identificador de registro: CTRP (Clinical Trials Reporting System))
- CDR0000459932 (Identificador de registro: PDQ (Physician Data Query))
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .