Phase II Trial of Rituximab in Combination With CHOP Chemotherapy in Patients With Previously Untreated Intermediate or High Grade Non-Hodgkin's Lymphoma
OBJECTIVES: I. Determine the rate of complete response and partial response in patients with
intermediate or high grade non-Hodgkin's lymphoma treated with rituximab plus
cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). II. Determine the
toxicity of this regimen in these patients. III. Determine the disease-free and overall
survival, time to response, and time to disease progression in patients treated with this
regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to the number of
risk factors (0-2 vs 3-5). Risk factors include age (no greater than 60 vs greater than 60),
tumor stage (II vs III or IV), number of extranodal sites (no more than 1 vs more than 1),
performance status (0-1 vs 2-4), and serum LDH level (no greater than normal vs greater than
normal). Patients receive rituximab IV on day 1; cyclophosphamide, doxorubicin, and
vincristine IV on day 3; and oral prednisone on days 3-7. Patients over 60 also receive
filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until blood counts
recover (all other patients receive G-CSF as secondary prophylaxis). Treatment continues
every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients who respond receive 2 more courses. Patients who have no measurable disease after 6
courses receive rituximab IV once weekly for 4 consecutive weeks. This treatment continues
every 6 months for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients who have measurable disease after 6 courses of chemotherapy receive 2 more courses
for a maximum of 8 courses of CHOP, followed by maintenance therapy with rituximab (as
described above). Patients are followed every 6 months for 2 years.
PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Carol Brannan, BS, BSN
Study Chair
Amgen
United States: Federal Government
CDR0000067940
NCT00005959
December 1999
Name | Location |
---|---|
Henry Ford Hospital | Detroit, Michigan 48202 |
Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Lakeland Medical Center - St. Joseph | Saint Joseph, Michigan 49085 |
Oncology-Hematology Group of South Florida | Miami, Florida 33176 |
University of Tennessee, Memphis | Memphis, Tennessee 38163 |
Mount Sinai Comprehensive Cancer Center | Miami Beach, Florida 33140 |
Our Lady of Mercy Medical Center | Bronx, New York 10466 |
Oncology/Hematology Care, Inc. | Cincinnati, Ohio 45219 |
Maine Center for Cancer Medicine and Blood Disorders | Scarborough, Maine 04074 |
New Mexico Oncology-Hematology | Albuquerque, New Mexico 87102 |
HemOnCare, P.C. | Brooklyn, New York 11235 |
Cancer and Blood Institute of the Desert | Rancho Mirage, California 92270 |
Hematology & Oncology Associates of Virginia | Richmond, Virginia 23226 |
Montgomery Cancer Center | Montgomery, Alabama 36106-3657 |
Southeast Florida Hematology-Oncology Group | Fort Lauderdale, Florida 33308 |
Hematology-Oncology Associates, PA | Pensacola, Florida 32501 |
Hutchinson Clinic, P.A. | Hutchinson, Kansas 67502 |
Hematology/Oncology Care Inc. | Crestview Hills, Kentucky 41017 |
Associates in Oncology and Hematology | Rockville, Maryland 20850 |
North Shore Cancer Center | Peabody, Massachusetts 01960 |
Bond Clinic | Rolla, Missouri 65401 |
Midwest Hematology Oncology Consultants, Ltd. | Saint Louis, Missouri 63136 |
Hematology Oncology Associates | Morristown, New Jersey 07962 |
N.W. Carolina Oncology & Hematology, P.A. | Hickory, North Carolina 28603 |
Intermountain Hematology/Oncology Associates, Inc. | Salt Lake City, Utah 84124 |
Vermont Center for Cancer Medicine, Inc. | Colchester, Vermont 05446 |