A Phase II Trial of Extended Induction Galiximab (Anti-CD80 Monoclonal Antibody) (IND #XXXXX) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)
OBJECTIVES:
Primary
- Determine the overall and complete response rate in patients with previously untreated
CD20-positive bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma
treated with rituximab and galiximab.
- Determine the time to disease progression in patients treated with this regimen.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Correlate Fc receptor polymorphism profiling with response in patients treated with
this regimen.
OUTLINE: This is a multicenter study.
- Induction therapy (month 1): Patients receive rituximab IV on days 1, 8, 15, and 22 and
galiximab IV over 1 hour on day 3, 8, 15, and 22.
- Extended induction therapy (months 3, 5, 7, and 9): Beginning in month 3, patients
receive rituximab and galiximab as above on day 1. Treatment repeats every 56 days for
4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 4 months for up to 10
years.
PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study within 18 months.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response
complete and partial response will be assessed
12 months
No
Myron S. Czuczman, MD
Study Chair
Roswell Park Cancer Institute
United States: Food and Drug Administration
CDR0000433340
NCT00117975
June 2005
March 2017
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Elliot Regional Cancer Center | Manchester, New Hampshire 03103 |
CCOP - Greenville | Greenville, South Carolina 29615 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
UMASS Memorial Cancer Center - University Campus | Worcester, Massachusetts 01605-2982 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
CancerCare of Maine at Eastern Maine Medial Center | Bangor, Maine 04401 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
New Hampshire Oncology-Hematology, PA - Hooksett | Hooksett, New Hampshire 03106 |
Memorial Cancer Institute at Memorial Regional Hospital | Hollywood, Florida 33021 |
New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
Lenoir Memorial Cancer Center | Kinston, North Carolina 28503-1678 |
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida 33458 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Eureka Community Hospital | Eureka, Illinois 61530 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Galesburg Clinic | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Hopedale Medical Complex | Hopedale, Illinois 61747 |
Kewanee Hospital | Kewanee, Illinois 61443 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
St. Margaret's Hospital | Spring Valley, Illinois 61362 |
Fort Wayne Medical Oncology and Hematology | Fort Wayne, Indiana 46815 |
St. Luke's Hospital | Cedar Rapids, Iowa 52402 |
Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene, New Hampshire 03431 |
Frisbie Memorial Hospital | Rochester, New Hampshire 03867 |
Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls, New York 12801 |
Community General Hospital of Greater Syracuse | Syracuse, New York 13215 |
Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
Wilson Medical Center | Wilson, North Carolina 27893-3428 |
Bon Secours St. Francis Health System | Greenville, South Carolina 29601 |
Mountainview Medical | Berlin, Vermont 05602 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224-1791 |
Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
McLeod Regional Medical Center | Florence, South Carolina 29501 |
Iowa Blood and Cancer Care | Cedar Rapids, Iowa 52402 |
St. Mary's Regional Cancer Center at St. Mary's Medical Center | Huntington, West Virginia 25702 |
CaroMont Cancer Center at Gaston Memorial Hospital | Gastonia, North Carolina 28053 |
Capital Region Cancer Center | Jefferson City, Missouri 65101 |
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville, Virginia 24115 |