A Phase II Study Of Rituximab-CHOP With Pegylated Liposomal Doxorubicin In Patients Older Than 60 Years Of Age With Untreated Aggressive B-Cell Non-Hodgkin's Lymphoma
Filgrastim
+ Pegfilgrastim
+ Rituximab
Maladies hématologiques et lymphatiques+8
+ Maladies du Système Immunitaire
+ Troubles immunoprolifératifs
Étude thérapeutique
Résumé
Date de début de l'étude : 1 septembre 2005
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Determine the clinical response rate in older patients with previously untreated aggressive diffuse large B-cell stage II-IV lymphoma treated with rituximab, cyclophosphamide, pegylated doxorubicin hydrochloride liposome (HCl), vincristine, and prednisone. * Determine the cardiotoxicity and myelosuppression of this regimen in these patients. Secondary * Determine disease-free survival and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive rituximab intravenous (IV), cyclophosphamide IV over 1-1½ hours, pegylated doxorubicin HCl liposome IV over 1 hour, and vincristine IV on day 1, and oral prednisone on days 1-5. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on day 6 (24 hours after the completion of chemotherapy). Treatment repeats every 21 days for up to 8 courses in the absence of unacceptable toxicity, disease progression, active hepatitis B virus infection, or hepatitis. Patients with no response OR who achieve less than a partial response after 4 courses are removed from the study. Patients are followed at 1 month, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter. PROJECTED ACCRUAL: A maximum of 80 patients will be accrued for this study within 27 months.
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.80 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.À partir de 61 ans
Tranche d'âge des participants éligibles à participer.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 diffuse large B-cell lymphoma * Stage II, III, or IV disease * Previously untreated disease * Measurable or evaluable disease * No primary central nervous system (CNS) lymphoma or follicular B-cell lymphoma PATIENT CHARACTERISTICS: Age * 61 and over Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,000/mm\^3\* * Platelet count \> 100,000/mm\^3\* NOTE: \* Unless due to lymphoma-related hypersplenism or bone marrow infiltration Hepatic * Bilirubin \< 2 mg/dL * Hepatitis B surface antigen negative * Hepatitis B core antibody negative * Hepatitis C Virus antibody negative Renal * Creatinine \< 2 mg/dL Cardiovascular * left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or ple gated acquisition (MUGA) scan * No uncontrolled hypertension or cardiac symptoms * Cardiologist consultation required for patients with stage A cardiac failure or any of the following known heart diseases: * Diastolic dysfunction * Prior coronary artery bypass graft * Prior percutaneous transluminal coronary angioplasty * Prior stent insertion * Prior radiotherapy to the chest * No myocardial infarction within the past 6 months * No New York Heart Association class II-IV heart failure * No uncontrolled angina * No severe uncontrolled ventricular arrhythmias * No clinically significant pericardial disease * No acute ischemic or active conduction system abnormality by electrocardiogram (EKG) Other * Not pregnant or nursing * Fertile patients must use effective contraception * No psychiatric illness that would preclude study compliance or giving informed consent * No other major life-threatening illness that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * See Cardiovascular Surgery * See Cardiovascular
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 7 sites
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, United StatesOuvrir Hembree Mercy Cancer Center at St. Edward Mercy Medical Center dans Google MapsCCOP - Grand Rapids
Grand Rapids, United StatesCCOP - Kalamazoo
Kalamazoo, United StatesCancer Research for the Ozarks
Springfield, United States