Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma
NCT ID: NCT00005959
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
INTERVENTIONAL
1999-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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filgrastim
rituximab
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 12 weeks Hematopoietic: Unless documented bone marrow disease: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT and SGPT no greater than 3 times upper limit of normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No history of severe heart disease, cardiomyopathy, or congestive heart failure LVEF normal by MUGA or echocardiogram Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection as defined by: Clinical syndrome consistent with a viral or bacterial infection (e.g., influenza, upper respiratory infection, urinary tract infection) OR Fever with a clinical site of infection identified OR Microbiologically documented infection, including, but not limited to, bacteremia or septicemia No known HIV positivity No known sensitivity to E. coli derivatives (e.g., asparaginase, human insulin, human growth hormone, interferon alfa-2b) No other prior malignancy within the past 5 years except surgically cured basal or squamous cell skin cancer or carcinoma in situ of the cervix No psychiatric, addictive, or other disorder that may preclude study
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent biologic therapy except epoetin alfa No white blood cell transfusions Chemotherapy: See Disease Characteristics No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: At least 2 weeks since prior major surgery Other: No other concurrent investigational therapy No prophylactic antibiotics
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Principal Investigators
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Carol Brannan, BS, BSN
Role: STUDY_CHAIR
Amgen
Locations
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Montgomery Cancer Center
Montgomery, Alabama, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States
Cancer and Blood Institute of the Desert
Rancho Mirage, California, United States
Southeast Florida Hematology-Oncology Group
Fort Lauderdale, Florida, United States
Oncology-Hematology Group of South Florida
Miami, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Hematology-Oncology Associates, PA
Pensacola, Florida, United States
Hutchinson Clinic, P.A.
Hutchinson, Kansas, United States
Hematology/Oncology Care Inc.
Crestview Hills, Kentucky, United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, United States
Associates in Oncology and Hematology
Rockville, Maryland, United States
North Shore Cancer Center
Peabody, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, United States
Bond Clinic
Rolla, Missouri, United States
Midwest Hematology Oncology Consultants, Ltd.
St Louis, Missouri, United States
Hematology Oncology Associates
Morristown, New Jersey, United States
New Mexico Oncology-Hematology
Albuquerque, New Mexico, United States
HemOnCare, P.C.
Brooklyn, New York, United States
Our Lady of Mercy Medical Center
The Bronx, New York, United States
N.W. Carolina Oncology & Hematology, P.A.
Hickory, North Carolina, United States
Oncology/Hematology Care, Inc.
Cincinnati, Ohio, United States
University of Tennessee, Memphis
Memphis, Tennessee, United States
Intermountain Hematology/Oncology Associates, Inc.
Salt Lake City, Utah, United States
Vermont Center for Cancer Medicine, Inc.
Colchester, Vermont, United States
Hematology & Oncology Associates of Virginia
Richmond, Virginia, United States
Countries
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Other Identifiers
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AMGEN-GCSF-990756
Identifier Type: -
Identifier Source: secondary_id
NCI-V00-1593
Identifier Type: -
Identifier Source: secondary_id
CDR0000067940
Identifier Type: -
Identifier Source: org_study_id