Spots Global Cancer Trial Database for Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma Patients
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Trial Identification
Brief Title: Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma Patients
Official Title: An Open-Label, Randomized, Phase 2 Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma Patients
Study ID: NCT00931918
Study Description
Brief Summary: This is a randomized, open-label, multi-center, phase 2 study of RCHOP with or without VELCADE in adult patients with previously untreated non-(Germinal B-Cell-like) GCB Diffuse Large B-cell Lymphoma (DLBCL). The study will determine whether the addition of VELCADE to RCHOP improves progression-free survival (PFS) in patients with non-GCB DLBCL.
Detailed Description: The drug tested in this study is called bortezomib (VELCADEĀ®). VELCADEĀ® was tested in people who have Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma. This study looked at the efficacy of RCHOP \[rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone\] with or without VELCADEĀ®. The study enrolled 206 patients. Participants were enrolled in one of the two open label treatment groups: * RCHOP * Vc-RCHOP \[bortezomib (VELCADEĀ®), rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone\] Participants received treatment for up to six, 21-day cycles. This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 48 months. Participants made multiple visits to the clinic, and were followed for progression free survival and overall survival until patient withdrawal, death, or 2 years after the last participant was enrolled.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Tower Cancer Research Foundation, Beverly Hills, California, United States
Fountain Valley Regional Hospital, Fountain Valley, California, United States
St. Jude Heritage Healthcare, Fullerton, California, United States
Moores Cancer Center- UCSD, La Jolla, California, United States
Antelope Valley Cancer Center, Lancaster, California, United States
Loma Linda University Cancer Center, Loma Linda, California, United States
University of Southern California, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
TORI- Central Pharmacy, Los Angeles, California, United States
TORI- Central Regulatory, Los Angeles, California, United States
Oncology Care Medical Associates, Montebello, California, United States
Bay Area Cancer Research Group, Pleasant Hill, California, United States
Wilshire Oncology Medical Group, Rancho Cucamonga, California, United States
Sharp Healthcare, San Diego, California, United States
Central Coast Medical Oncology Corporation, Santa Maria, California, United States
Rocky Mountain Cancer Center, Denver, Colorado, United States
Florida Cancer Specialists, Fort Myers, Florida, United States
Florida Cancer Specialists & Research Institute, Gainsville, Florida, United States
Alves/ Domenech Oncology-Hematology Clinic, Hollywood, Florida, United States
Florida Cancer Institute ATI, New Port Richey, Florida, United States
MD Anderson Cancer Center of Orlando, Orlando, Florida, United States
Coastal Oncology, PL, Ormond Beach, Florida, United States
Winship Cancer Institute at Emory University, Atlanta, Georgia, United States
Georgia Cancer Specialists, Atlanta, Georgia, United States
Dublin Hematology and Oncology, Dublin, Georgia, United States
Rush University Medical Center, Chicago, Illinois, United States
Central Indiana Cancer Centers, Fishers, Indiana, United States
Cancer Care Center Inc. P.C., New Albany, Indiana, United States
Iowa Blood and Cancer Care, Cedar Rapids, Iowa, United States
Iowa Oncology Research Association, Des Moines, Iowa, United States
Siouxland Hematology and Oncology Associates LLP, Sioux City, Iowa, United States
Kansas City Cancer Center, LLC, Overland Park, Kansas, United States
Sinai Hospital of Baltimore, Baltimore, Maryland, United States
St. Agnes Hospital of Baltimore, Baltimore, Maryland, United States
Holy Cross Hospital, Silver Spring, Maryland, United States
Lahey Clinic Medical Center, Burlington, Massachusetts, United States
Berkshie Hematology Oncology, Pittsfield, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Mid Michigan Physicians, Lansing, Michigan, United States
Duluth Clinic, Duluth, Minnesota, United States
St. Luke's Hospital Cancer Care Center, Duluth, Minnesota, United States
Missouri Cancer Associates, Columbia, Missouri, United States
Saint Luke's Cancer Institute, Kansas City, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Hematology/Oncology Associates of Northern New Jersey, P.A., Morristown, New Jersey, United States
Hematology Oncology Associates of South Jersey, Mount Holly, New Jersey, United States
St. Luke's- Roosevelt Medical Center, New York, New York, United States
Cornell, New York, New York, United States
Raleigh Hematology Oncology Associates P.C., Raleigh, North Carolina, United States
Summa Health System, Akron, Ohio, United States
Oncology Hematology Care, Cincinnati, Ohio, United States
Kaiser Group Health, Portland, Oregon, United States
Hematology and Oncology Associates of NEPA, Dunmore, Pennsylvania, United States
UPMC Cancer Center, Pittsburgh, Pennsylvania, United States
Guthrie Clinic, Sayre, Pennsylvania, United States
Berks Hematology Oncology Associates, W Reading, Pennsylvania, United States
South Carolina Oncology Associates, PA, Columbia, South Carolina, United States
Chattanooga Oncology and Hematology Associates, PC, Chattanooga, Tennessee, United States
Tennessee Oncology, Nashville, Tennessee, United States
Texas Oncology Cancer Center, Austin, Texas, United States
US Oncology- Central Drug, Fort Worth, Texas, United States
US Oncology- Central Laboratory, Fort Worth, Texas, United States
Oncology Consultants P.A., Houston, Texas, United States
Oncology Consultants, Houston, Texas, United States
US Oncology- Central Regulatory, The Woodlands, Texas, United States
Tyler Cancer Center, Tyler, Texas, United States
Texoma Cancer Center, Wichita Falls, Texas, United States
Virginia Cancer Institute, Richmond, Virginia, United States
Puget Sound Cancer Centers, Edmonds, Washington, United States
Northwest Cancer Specialists PC, Vancover, Washington, United States
Contact Details
Name: Medical Monitor
Affiliation: Millennium Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
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