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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

Phase 3
18 Years
Open (Enrolling)

Thank you

Trial Information

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


- 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

- Determine the incidence and time to development of human anti-mouse antibody

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

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)

Inclusion Criteria


- Histologically confirmed previously untreated bulky stage II or stage III or IV
follicular non-Hodgkin's lymphoma

- Grade I-III disease

- Cluster of differentiation antigen 20 (CD20) antigen positive

- Fewer than 5,000/mm^3 circulating lymphoid cells on a white blood cell (WBC)
differential count

- Bidimensionally measurable disease

- Bone marrow aspiration and biopsy within the past 42 days

- No clinical evidence of central nervous system (CNS) involvement by lymphoma



- 18 and over

Performance status:

- Zubrod 0-2

Life expectancy:

- Not specified


- See Disease Characteristics

- Granulocyte count greater than 1,500/mm^3

- Platelet count greater than 100,000/mm^3


- Not specified


- Not specified


- No impaired cardiac status, including:

- Severe coronary artery disease

- Cardiomyopathy

- Congestive heart failure

- Serious arrhythmia

- Ejection fraction at least lower limit of normal by Multi Gated Acquisition Scan
(MUGA) or 2-D echocardiogram for questionable cardiac history


- No hypersensitivity to iodine

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 6 months after study

- HIV negative

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix


Biologic therapy:

- No prior monoclonal antibodies for cancer


- No prior chemotherapy for lymphoma

- Prior prednisone for non-lymphoma related illnesses allowed

Endocrine therapy:

- Not specified


- No prior radiotherapy for lymphoma


- See Disease Characteristics

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival at 2 Years

Outcome Description:

Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date

Outcome Time Frame:

0-2 years

Safety Issue:


Principal Investigator

Oliver W. Press, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center


United States: Federal Government

Study ID:




Start Date:

March 2001

Completion Date:

Related Keywords:

  • Lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin



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
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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
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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
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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
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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
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St. Peter's Hospital Helena, Montana  59601
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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
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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
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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
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Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
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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
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Helen and Harry Gray Cancer Center at Hartford Hospital Hartford, Connecticut  06102-5037
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Howard Community Hospital Kokomo, Indiana  46904
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Marin Cancer Institute at Marin General Hospital Greenbrae, California  94904
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Kennestone Cancer Center at Wellstar Kennestone Hospital Marietta, Georgia  30060
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Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
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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
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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
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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