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
Enfermedades hemáticas y linfáticas+6
+ Enfermedades del sistema inmunitario
+ Trastornos Inmunoproliferativos
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de septiembre de 2005
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 80 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 61 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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 Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 7 ubicaciones
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, United StatesAbrir Hembree Mercy Cancer Center at St. Edward Mercy Medical Center en Google MapsCCOP - Grand Rapids
Grand Rapids, United StatesCCOP - Kalamazoo
Kalamazoo, United StatesCancer Research for the Ozarks
Springfield, United States