64
Participants
Start Date
April 7, 2016
Primary Completion Date
November 8, 2018
Study Completion Date
January 19, 2021
Ibrutinib
Ibrutinib 560 mg daily for 14 days during induction cycles. Maintenance phase: Continuous cycles until disease progression or unacceptable toxicity (maximum of 2 years).
Rituximab
Rituximab 375 mg/m2 IV day 1 during 4 cycles.
Gemcitabine
Gemcitabine 1000 mg/m2 IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days.
Oxaliplatin
Oxaliplatin 100 mg/m2 (3-hour infusion) on day 1 or 2, after Gemcitabine infusion, 4 cycles every 14 days.
Dexamethasone
Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days.
Hospital Especialidades, Jerez de la Frontera
Hospital Universitario Donostia, Donostia / San Sebastian
Complejo Hospitalario de Jaén, Jaén
Hospital Universitario Infanta Leonor, Madrid
MD Anderson Cancer Center, Madrid
Hospital Universitario 12 de Octubre, Madrid
Hospital General Universitario Morales Meseguer, Murcia
Hospital de Navarra, Pamplona
Hospital Universitario Central de Asturias, Oviedo
Hospital Universitario Virgen del Rocío, Seville
Hospital Clínic Universitari de València, Valencia
Hospital Universitario y Politécnico La Fe, Valencia
Hospital Clínico Universitario de Valladolid, Valladolid
Hospital Universitario Son Espases, Palma
Complexo Hospitalario Universitario de Vigo, Vigo
Hospital Universitario Vall d'Hebron, Barcelona
Hospital Clínic de Barcelona, Barcelona
Janssen-Cilag, S.A.
INDUSTRY
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
OTHER