A Phase II Trial of Bortezomib (NSC #681239) + Lenalidomide (Revlimid ™, CC-5013) (NSC #703813) for Relapsed/Refractory Mantle Cell Lymphoma
PRIMARY OBJECTIVES:
I. To determine the overall response (complete response [CR] and partial response) rate and
the 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 therapy
in patients with relapsed or refractory mantle cell lymphoma.
II. To determine the disease-free and overall survival after therapy with bortezomib +
lenalidomide therapy 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 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 once daily 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 periodically.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate defined as complete response and partial response
Estimated using the uniformly minimum unbiased estimator. Jennison and Turnbull's method will be used to obtain 90% exact confidence interval. Summarized using frequency tables.
Assessed up to 6 years
No
Vicki Morrison
Principal Investigator
Cancer and Leukemia Group B
United States: Food and Drug Administration
NCI-2009-00483
NCT00553644
November 2007
Name | Location |
---|---|
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Eastern Maine Medical Center | Bangor, Maine 04401 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Southern California Permanente Medical Group | Downey, California 90242 |
Munson Medical Center | Traverse City, Michigan 49684 |
Brigham and Women's Hospital | Boston, Massachusetts 02115 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
Beebe Medical Center | Lewes, Delaware 19958 |
Memorial Hospital | Carthage, Illinois 62321 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Galesburg Clinic | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Proctor Hospital | Peoria, Illinois 61614 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
Valley Cancer Center | Spring Valley, Illinois 61362 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Mountainview Medical | Berlin, Vermont 05602 |
Eureka Hospital | Eureka, Illinois 61530 |
Graham Hospital Association | Canton, Illinois 61520 |
Pekin Hospital | Pekin, Illinois 61554 |
Harold Alfond Center for Cancer Care | Augusta, Maine 04330 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
McLeod Regional Medical Center | Florence, South Carolina 29501 |
Metro Health Hospital | Grand Rapids, Michigan 49506 |
Newton-Wellesley Hospital | Newton, Massachusetts 02462 |
Kaiser Permanente Medical Center | Vallejo, California 94589 |
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
University Of Vermont | Burlington,, Vermont 05403 |
Kaiser Permanente | Sacramento, California |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
Lombardi Comprehensive Cancer Center at Georgetown University | Washington, District of Columbia 20057 |
Intercommunity Cancer Center | Galesburg, Illinois 61401 |
Hopedale Medical Complex - Hospital | Hopedale, Illinois 61747 |
Community Cancer Center Foundation | Normal, Illinois 61761 |
Illinois CancerCare-Ottawa Clinic | Ottawa, Illinois 61350 |
Ottawa Regional Hospital and Healthcare Center | Ottawa, Illinois 61350 |
Pekin Cancer Treatment Center | Pekin, Illinois 61554 |
Illinois Oncology Research Association CCOP | Peoria, Illinois 61615 |
Illinois CancerCare-Peoria | Peoria, Illinois 61615 |
Illinois Valley Hospital | Peru, Illinois 61354 |
Saint Margaret's Hospital | Spring Valley, Illinois 61362 |
Hematology Oncology Associates-Quad Cities | Bettendorf, Iowa 52722 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Spectrum Health at Butterworth Campus | Grand Rapids, Michigan 49503 |
Mercy Health Partners-Mercy Campus | Muskegon, Michigan 49443 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
State University of New York Upstate Medical University | Syracuse, New York 13210 |
Mission Hospitals Inc | Asheville, North Carolina 28801 |
Kinston Medical Specialists PA | Kinston, North Carolina 28501 |
University of Missouri - Ellis Fischel | Columbia, Missouri 65203 |
Veterans Administration | Columbia, Missouri 65201 |
University of Minnesota Medical Center-Fairview | Minneapolis, Minnesota 55455 |
Kaiser Anaheim Medical Center | Anaheim, California 92807 |
Kaiser Permanente Medical Group - Baldwin Park | Baldwin Park, California 91706 |
Kaiser Foundation Hospital | Bellflower, California 90706 |
Kaiser Permanente Hospital | Fontana, California 92335 |
Kaiser Permanente - Harbor City | Harbor City, California 90710 |
Kaiser Permanente-West Los Angeles | Los Angeles, California 90034 |
Kaiser Permanente - Panorama City | Panorama City, California 91402 |
Kaiser Permanente at San Diego | San Diego, California 92120 |
Kaiser Permanente Health Care | San Marcos, California 92069 |
Kaiser Permanente-Mission | San Diego, California 92108 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
Bronson Battle Creek | Battle Creek, Michigan 49017 |