A phase 3 open label randomized study to compare the efficacy and safety of rituximab plus lenalidomide (CC-5013) versus rituximab plus chemotherapy followed by rituximab in subjects with previously untreated follicular lymphoma. Estudio en fase 3, abierto, aleatorizado, para comparer la eficacia y seguridad de Rituximab más Lenalidomida (CC-5013) frente a Rituximab más quimioterapia, seguido de Rituximab en pacientes con Linfoma Folicular sin tratamiento previo
ESTADO CLÍNICO
En marcha
FASE/S DEL ENSAYO
Fase III
PATOLOGÍA
Coagulopatías hemorrágicas, Leucemia mieloide aguda, Linfoma no Hodgkin, Terapia celular y T-CARs, Linfoma Folicular, Linfoma
CENTRO INVESTIGADOR
H.U. Ramón y Cajal
INVESTIGADOR PRINCIPAL
JAVIER LOPEZ JIMENEZ
FECHA DE APERTURA
Ocutbre, 2013
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
Stage II-IV follicular lymphoma grade 1-3a not previously treated Linfoma folicular en estadio II-IV, grado 1-3a no previamente tratado
CRITERIOS DE EXCLUSIÓN
14.1
DESCRIPCIÓN
The tumor response data will be assessed by the IRC using the IWG (Cheson 1999) criteria. Based on the CT/MRI schedule, any assessments in a time window of 120 weeks +/- 4 weeks are qualified as the 120 weeks assessments. If two or more assessments are performed in this time window, the assessment with the least favorable response will be used. PFS is an accepted endpoint of clinical benefit for previously untreated FL patient and was the basis for the recent approval of rituximab maintenance in this population (Salles 2011). The disease progression status will be assessed by IRC using the IWG (Cheson 1999) criteria. PFS is defined as the time from randomization into the study to the first observation of documented disease progression or death due to any cause. If a patient has not progressed or died, PFS will be censored at the time of last visit with adequate assessment. If a patient received other anti-cancer treatment for follicular lymphoma before progression, the CT/MRI assessments should continue as scheduled until disease progression or death which will be counted as events. Las covariables de eficacia primarias son la tasa de respuesta completa (RC / RCnc) y SLP (supervivencia libre de progresión).
PALABRAS CLAVE
cd20, factor xi, follicular lymphoma, gene therapy, linfoma, linfoma folicular, linfoma t, lymphoma, mrd, ph + acute lymphoblastic leukemia
