A Phase III Trial of CHOP Plus Rituximab vs CHOP Plus Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) for Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas
OBJECTIVES:
- Compare the progression-free survival and overall survival of patients with newly
diagnosed follicular non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin,
vincristine, and prednisone (CHOP) with or without either rituximab or iodine I 131
tositumomab (monoclonal antibody anti-B1). (CHOP chemotherapy alone arm closed to
accrual as of 12/15/02)
- Compare the response rate of these patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Compare the molecular remission rates of this patient population treated with these
regimens.
- Determine the incidence and time to development of human anti-mouse antibody
positivity.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
whether microglobulin is greater than upper limit of normal (yes vs no). Patients are
randomized to 1 of 3 treatment arms. (Arm I closed to accrual as of 12/15/02)
- Arm I (CHOP only): Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV
over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive
oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6
courses in the absence of disease progression or unacceptable toxicity. (Arm I closed
to accrual as of 12/15/02)
- Arm II (CHOP + rituximab): Patients receive cyclophosphamide IV over 15 minutes,
doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29,
50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33,
50-54, 71-75, and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134,
and 141.
- Arm III (CHOP + tositumomab): Patients receive chemotherapy as in arm I and tositumomab
(monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV
over 20 minutes on days 134 and 141.
Patients are followed on day 200, at 1 year, every 6 months for 2 years, and then annually
thereafter.
PROJECTED ACCRUAL: Approximately 500 patients (250 per treatment arm) will be accrued for
this study within 5.5 years. (Arm I closed to accrual as of 12/15/02)
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival at 2 Years
Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date
0-2 years
No
Oliver W. Press, MD, PhD
Study Chair
Fred Hutchinson Cancer Research Center
United States: Federal Government
CDR0000068321
NCT00006721
March 2001
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
St. Rita's Medical Center | Lima, Ohio 45801 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Greenville | Greenville, South Carolina 29615 |
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma, Washington 98405 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Dwight David Eisenhower Army Medical Center | Fort Gordon, Georgia 30905-5650 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Wesley Medical Center | Wichita, Kansas 67214 |
Palmetto Health South Carolina Cancer Center | Columbia, South Carolina 29203 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Northside Hospital Cancer Center | Atlanta, Georgia 30342-1611 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Sacred Heart Cancer Center at Sacred Heart Hospital | Pensacola, Florida 32504 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore, Maryland 21215 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
Lahey Clinic Medical Center - Burlington | Burlington, Massachusetts 01805 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Alaska Regional Hospital Cancer Center | Anchorage, Alaska 99508 |
Saint Anthony's Hospital at Saint Anthony's Health Center | Alton, Illinois 62002 |
Good Samaritan Regional Health Center | Mt. Vernon, Illinois 62864 |
Southwest Medical Center | Liberal, Kansas 67901 |
Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
Holland Community Hospital | Holland, Michigan 49423 |
Hackley Hospital | Muskegon, Michigan 49443 |
Munson Medical Center | Traverse City, Michigan 49684 |
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau, Missouri 63701 |
David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
Big Sky Oncology | Great Falls, Montana 59405 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Community Medical Center | Missoula, Montana 59801 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
Olympic Hematology and Oncology | Bremerton, Washington 98310 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Harborview Medical Center | Seattle, Washington 98104 |
Group Health Central Hospital | Seattle, Washington 98104 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Veterans Affairs Medical Center - Hines | Hines, Illinois 60141 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise, Idaho 83712-6297 |
University of Illinois Cancer Center | Chicago, Illinois 60612-7243 |
Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
Legacy Emanuel Hospital and Health Center and Children's Hospital | Portland, Oregon 97227 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Helen and Harry Gray Cancer Center at Hartford Hospital | Hartford, Connecticut 06102-5037 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Howard Community Hospital | Kokomo, Indiana 46904 |
Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
Peninsula Medical Center | Burlingame, California 94010 |
Sutter Health - Western Division Cancer Research Group | Greenbrae, California 94904 |
Marin Cancer Institute at Marin General Hospital | Greenbrae, California 94904 |
California Pacific Medical Center - California Campus | San Francisco, California 94118 |
Sutter Solano Medical Center | Vallejo, California 94589 |
Saint Joseph's Hospital of Atlanta | Atlanta, Georgia 30342-1701 |
Piedmont Hospital | Atlanta, Georgia 30309 |
WellStar Cobb Hospital | Austell, Georgia 30106 |
Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur, Georgia 30033 |
Gwinnett Medical Center | Lawrenceville, Georgia 30045 |
Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta, Georgia 30060 |
Southern Regional Medical Center | Riverdale, Georgia 30274-2600 |
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Eureka Community Hospital | Eureka, Illinois 61530 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Hopedale Medical Complex | Hopedale, Illinois 61747 |
McDonough District Hospital | Macomb, Illinois 61455 |
Edward Hospital Cancer Center | Naperville, Illinois 60540 |
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 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
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 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Bay Regional Medical Center | Bay City, Michigan 48708 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Community Oncology Group at Cleveland Clinic Cancer Center | Independence, Ohio 44131 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
Mercy Medical Center | Springfield, Ohio 45504 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Providence St. Vincent Medical Center | Portland, Oregon 97225 |
Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
UMC Southwest Cancer and Research Center | Lubbock, Texas 79415-3364 |
Minor and James Medical, PLLC | Seattle, Washington 98104 |
Polyclinic First Hill | Seattle, Washington 98122 |
Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital | Fairbanks, Alaska 99701 |
St. Francis Hospital | Federal Way, Washington 98003 |
Cascade Cancer Center at Evergreen Hospital Medical Center | Kirkland, Washington 98034-3013 |
St. Clare Hospital | Lakewood, Washington 98499-0998 |
Olympic Medical Center | Port Angeles, Washington 98362 |
Good Samaritan Cancer Center | Puyallup, Washington 98371 |
Valley Medical Center | Renton, Washington 98055 |
Allenmore Hospital | Tacoma, Washington 98411-0414 |
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center | Ft. Smith, Arkansas 72903 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Pearlman Comprehensive Cancer Center at South Georgia Medical Center | Valdosta, Georgia 31603 |
Saint Luke's Hospital | Chesterfield, Missouri 63017 |
Alta Bates Summit Comprehensive Cancer Center | Berkeley, California 94704 |
Stanford Cancer Center | Stanford, California 94305-5824 |
West Florida Cancer Institute at West Florida Hospital - Pensacola | Pensacola, Florida 32514 |
Reid Hospital & Health Care Services | Richmond, Indiana 47374 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Menorah Medical Center | Overland Park, Kansas 66209 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Shawnee Mission Medical Center | Shawnee Mission, Kansas 66204 |
Cotton-O'Neil Cancer Center | Topeka, Kansas 66606 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Truman Medical Center - Hospital Hill | Kansas City, Missouri 64108 |
St. Joseph Medical Center | Kansas City, Missouri 64114 |
North Kansas City Hospital | Kansas City, Missouri 64116 |
Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City, Missouri 64111 |
Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
St. James Healthcare Cancer Care | Butte, Montana 59701 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Sletten Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
Mary Rutan Hospital | Bellefontaine, Ohio 43311 |
Grant Medical Center Cancer Care | Columbus, Ohio 43215 |
Mount Carmel St. Ann's Cancer Center | Westerville, Ohio 43081 |
Clinton Memorial Hospital | Wilmington, Ohio 45177 |
Adventist Medical Center | Portland, Oregon 97216 |
Legacy Good Samaritan Hospital & Comprehensive Cancer Center | Portland, Oregon 97210 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
Columbia Basin Hematology | Kennewick, Washington 99336 |
Franciscan Cancer Center at St. Joseph Medical Center | Tacoma, Washington 98405-3004 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Schiffler Cancer Center at Wheeling Hospital | Wheeling, West Virginia 26003 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney, Nebraska 68848-1990 |
Tucker Center for Cancer Care at Orange Regional Medical Center | Middletown, New York 10940-4199 |
St. John's Regional Medical Center | Joplin, Missouri 64804 |
Freeman Cancer Institute at Freeman Health System | Joplin, Missouri 64803-2644 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Metro Health Hospital | Grand Rapids, Michigan 49506 |
Great Falls, Montana 59405 | |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
Roper St. Francis Cancer Center at Roper Hospital | Charleston, South Carolina 29401 |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
Good Samaritan Hospital Cancer Treatment Center | Cincinnati, Ohio 45220 |
Desert Regional Medical Center Comprehensive Cancer Center | Palm Springs, California 92262 |
Center for Cancer Care and Research at Watson Clinic, LLP | Lakeland, Florida 33805 |
Providence Medical Center | Kansas City, Kansas 66112 |
Johnson County Radiation Therapy | Overland Park, Kansas 66210 |
Berkshire Hematology Oncology, PC | Pittsfield, Massachusetts 01201 |
Oncology Care Associates, PLLC | Saint Joseph, Michigan 49085 |
Independence Regional Health Center | Independence, Missouri 64050 |
Kansas City Cancer Center at St. Joseph's Medical Mall | Kansas City, Missouri 64114 |
Parvin Radiation Oncology | Kansas City, Missouri 64116 |
Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center | Kansas City, Missouri 64154 |
Midwest Hematology Oncology Group, Incorporated | Saint Louis, Missouri 63109 |
Lynchburg Hematology-Oncology Clinic | Lynchburg, Virginia 24501 |