Spots Global Cancer Trial Database for Bortezomib and Lenalidomide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
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Trial Identification
Brief Title: Bortezomib and Lenalidomide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
Official Title: A Phase II Trial of Bortezomib (NSC #681239) + Lenalidomide (Revlimid™, CC-5013) (NSC #703813) for Relapsed/Refractory Mantle Cell Lymphoma
Study ID: NCT00553644
Conditions
Study Description
Brief Summary: This phase II trial studies how well bortezomib and lenalidomide work in treating patients with mantle cell lymphoma that has come back after a period of improvement (refractory) or is not responding to treatment (refractory). Bortezomib may also stop the growth of cancer cells by blocking some proteins needed for cell growth. Lenalidomide may stimulate the immune system to kill cancer cells and may also block the growth of new blood vessels necessary for cell growth. Giving bortezomib with lenalidomide may be an effective treatment for relapsed or refractory mantle cell lymphoma.
Detailed Description: PRIMARY OBJECTIVES: I. To determine the overall response (complete response \[CR\] and partial response \[PR\]) rate and the complete response (CR) rate to bortezomib + lenalidomide therapy in patients with relapsed or refractory mantle cell lymphoma. SECONDARY OBJECTIVES: I. To determine the time to progression after therapy with bortezomib + lenalidomide in patients with relapsed or refractory mantle cell lymphoma. II. To determine the disease-free survival and overall survival after therapy with bortezomib + lenalidomide in patients with relapsed or refractory mantle cell lymphoma. OUTLINE: Patients receive induction therapy comprising bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide orally (PO) once daily (QD) on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib IV on days 1 and 8 and lenalidomide PO QD on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually for 2 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Kaiser Permanente-Anaheim, Anaheim, California, United States
Kaiser Permanente-Baldwin Park, Baldwin Park, California, United States
Kaiser Permanente-Bellflower, Bellflower, California, United States
Kaiser Permanente-Fontana, Fontana, California, United States
Kaiser Permanente - Harbor City, Harbor City, California, United States
Kaiser Permanente-Irvine, Irvine, California, United States
Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States
Kaiser Permanente-Cadillac, Los Angeles, California, United States
Kaiser Permanente - Panorama City, Panorama City, California, United States
Kaiser Permanente-Riverside, Riverside, California, United States
Kaiser Permanente-San Diego Mission, San Diego, California, United States
Kaiser Permanente-San Diego Zion, San Diego, California, United States
Kaiser Permanente-San Marcos, San Marcos, California, United States
Kaiser Permanente-Woodland Hills, Woodland Hills, California, United States
Hartford Hospital, Hartford, Connecticut, United States
Beebe Medical Center, Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Graham Hospital Association, Canton, Illinois, United States
Memorial Hospital, Carthage, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Heartland Cancer Research NCORP, Decatur, Illinois, United States
Eureka Hospital, Eureka, Illinois, United States
Galesburg Cottage Hospital, Galesburg, Illinois, United States
Illinois CancerCare-Galesburg, Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center, Galesburg, Illinois, United States
Mason District Hospital, Havana, Illinois, United States
Hopedale Medical Complex - Hospital, Hopedale, Illinois, United States
Mcdonough District Hospital, Macomb, Illinois, United States
Bromenn Regional Medical Center, Normal, Illinois, United States
Community Cancer Center Foundation, Normal, Illinois, United States
Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States
Ottawa Regional Hospital and Healthcare Center, Ottawa, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center, Pekin, Illinois, United States
Pekin Hospital, Pekin, Illinois, United States
Proctor Hospital, Peoria, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
Illinois Valley Hospital, Peru, Illinois, United States
Valley Radiation Oncology, Peru, Illinois, United States
Perry Memorial Hospital, Princeton, Illinois, United States
Saint Margaret's Hospital, Spring Valley, Illinois, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne, Indiana, United States
University of Iowa Healthcare Cancer Services Quad Cities, Bettendorf, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Harold Alfond Center for Cancer Care, Augusta, Maine, United States
Eastern Maine Medical Center, Bangor, Maine, United States
Union Hospital of Cecil County, Elkton, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Newton-Wellesley Hospital, Newton, Massachusetts, United States
Bronson Battle Creek, Battle Creek, Michigan, United States
Spectrum Health Big Rapids Hospital, Big Rapids, Michigan, United States
Cancer Research Consortium of West Michigan NCORP, Grand Rapids, Michigan, United States
Mercy Health Saint Mary's, Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, United States
Mercy Health Mercy Campus, Muskegon, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
Metro Health Hospital, Wyoming, Michigan, United States
Minneapolis Veterans Medical Center, Minneapolis, Minnesota, United States
University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States
Veterans Administration, Columbia, Missouri, United States
University of Missouri - Ellis Fischel, Columbia, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Cooper Hospital University Medical Center, Camden, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Hematology Oncology Associates of Central New York-East Syracuse, East Syracuse, New York, United States
State University of New York Upstate Medical University, Syracuse, New York, United States
Mission Hospital Inc-Memorial Campus, Asheville, North Carolina, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
Novant Health Presbyterian Medical Center, Charlotte, North Carolina, United States
Wayne Memorial Hospital, Goldsboro, North Carolina, United States
Vidant Oncology-Kinston, Kinston, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
McLeod Regional Medical Center, Florence, South Carolina, United States
Central Vermont Medical Center/National Life Cancer Treatment, Berlin, Vermont, United States
University of Vermont College of Medicine, Burlington, Vermont, United States
Danville Regional Medical Center, Danville, Virginia, United States
Sovah Health Martinsville, Martinsville, Virginia, United States
Contact Details
Name: Vicki Morrison
Affiliation: Alliance for Clinical Trials in Oncology
Role: PRINCIPAL_INVESTIGATOR
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