Phase II Study Of Dose-Adjusted Epoch-Rituximab (EPOCH-R) Chemotherapy For Patients With Previously Untreated Aggressive CD20+ B-Cell Non-Hodgkin's Lymphoma (NHL)
filgrastim
+ rituximab
+ cyclophosphamide
Hemic and Lymphatic Diseases+9
+ Immune System Diseases
+ Immunoproliferative Disorders
Treatment Study
Summary
Study start date: February 1, 2002
Actual date on which the first participant was enrolled.OBJECTIVES: * Determine the response rate, progression-free survival, and overall survival of patients with previously untreated aggressive CD20+ B-cell diffuse large cell or immunoblastic large cell lymphoma treated with rituximab, doxorubicin, etoposide, vincristine, prednisone, and cyclophosphamide. * Determine the toxic effects of this regimen in these patients. * Correlate tumor proliferation rate (MIB-1), bcl-2 expression, and p53 overexpression with complete response rate, progression-free survival, and overall survival in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive rituximab IV on day 1; doxorubicin IV continuously, etoposide IV continuously, and vincristine IV continuously on days 1-4; oral prednisone twice daily on days 1-5; and cyclophosphamide IV on day 5. Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients with complete or partial response receive 2 additional courses. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 1 year.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.78 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed stage II, III, or IV diffuse large cell lymphoma and WHO variants * CD20+ large B-cell lymphoma, including those with immunoblastic features * CD20+ thymic B-cell lymphoma * No evidence of indolent lymphoma * No mantle cell lymphomas or equivocal B-cell lymphomas that express markers of mantle cell lymphoma (e.g., cyclin D) or other subtypes * No known lymphomatous involvement of the CNS, including the parenchyma or leptomeninges PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * CALGB 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,000/mm3\* * Platelet count at least 100,000/mm3\* NOTE: \* Unless due to lymphoma Hepatic: * Bilirubin no greater than 2.0 mg/dL\* NOTE: \* Unless due to lymphoma or Gilbert's disease Renal: * Creatinine no greater than 1.5 mg/dL\* NOTE: \* Unless due to lymphoma Cardiovascular: * LVEF greater than 45% * No ischemic heart disease * No myocardial infarction or congestive heart failure within the past year Other: * HIV negative * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior cytotoxic chemotherapy * No other concurrent chemotherapy Endocrine therapy: * Prior short-course of glucocorticoids allowed * No concurrent hormones except for non-disease-related conditions (e.g., insulin for diabetes) * No concurrent steroids except for adrenal failure * No concurrent dexamethasone or other steroidal antiemetics Radiotherapy: * Prior limited-field radiotherapy allowed Surgery: * Not specified
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 81 locations
Northeast Alabama Regional Medical Center
Anniston, United StatesOpen Northeast Alabama Regional Medical Center in Google MapsRebecca and John Moores UCSD Cancer Center
La Jolla, United StatesCedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, United StatesNaval Medical Center - San Diego
San Diego, United States