Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00005959
- Lead Sponsor
- Amgen
- Brief Summary
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with rituximab may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab plus combination chemotherapy in treating patients who have intermediate-grade or high-grade non-Hodgkin's lymphoma.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
Cancer and Blood Institute of the Desert
🇺🇸Rancho Mirage, California, United States
Oncology/Hematology Care, Inc.
🇺🇸Cincinnati, Ohio, United States
Intermountain Hematology/Oncology Associates, Inc.
🇺🇸Salt Lake City, Utah, United States
Southeast Florida Hematology-Oncology Group
🇺🇸Fort Lauderdale, Florida, United States
Hematology Oncology Associates
🇺🇸Morristown, New Jersey, United States
Hematology/Oncology Care Inc.
🇺🇸Crestview Hills, Kentucky, United States
North Shore Cancer Center
🇺🇸Peabody, Massachusetts, United States
Oncology-Hematology Group of South Florida
🇺🇸Miami, Florida, United States
Maine Center for Cancer Medicine and Blood Disorders
🇺🇸Scarborough, Maine, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Midwest Hematology Oncology Consultants, Ltd.
🇺🇸Saint Louis, Missouri, United States
Montgomery Cancer Center
🇺🇸Montgomery, Alabama, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Providence Saint Joseph Medical Center - Burbank
🇺🇸Burbank, California, United States
Hutchinson Clinic, P.A.
🇺🇸Hutchinson, Kansas, United States
Hematology-Oncology Associates, PA
🇺🇸Pensacola, Florida, United States
Bond Clinic
🇺🇸Rolla, Missouri, United States
Associates in Oncology and Hematology
🇺🇸Rockville, Maryland, United States
Lakeland Medical Center - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Our Lady of Mercy Medical Center
🇺🇸Bronx, New York, United States
HemOnCare, P.C.
🇺🇸Brooklyn, New York, United States
N.W. Carolina Oncology & Hematology, P.A.
🇺🇸Hickory, North Carolina, United States
University of Tennessee, Memphis
🇺🇸Memphis, Tennessee, United States
Vermont Center for Cancer Medicine, Inc.
🇺🇸Colchester, Vermont, United States
New Mexico Oncology-Hematology
🇺🇸Albuquerque, New Mexico, United States
Hematology & Oncology Associates of Virginia
🇺🇸Richmond, Virginia, United States