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
Maladies hématologiques et lymphatiques+9
+ Maladies du Système Immunitaire
+ Troubles immunoprolifératifs
Étude thérapeutique
Résumé
Date de début de l'étude : 1 février 2002
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.78 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 81 sites
Northeast Alabama Regional Medical Center
Anniston, United StatesOuvrir Northeast Alabama Regional Medical Center dans 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