Ibrutinib in Combination With Rituximab in Patients With Indolent Clinical Forms of MCL

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

May 18, 2016

Primary Completion Date

December 31, 2019

Study Completion Date

December 31, 2024

Conditions
Mantle Cell Lymphoma
Interventions
DRUG

IBRUTINIB

Ibrutinib 560 mg daily po for 28 days (cycle one). Continuous cycles until disease progression or unacceptable toxicity.

DRUG

Rituximab

Rituximab 375 mg/m2 iv day 1,8, 15 and 22 (cycle 1, 4 doses). Rituximab 375 mg/m2 iv, day one of every other cycle for 4 doses (cycle 3, 5, 7 and 9).

Trial Locations (15)

28041

Hospital Universitario 12 de Octubre, Madrid

Unknown

Hospital Universitario Mútua Terrassa, Terrassa

Hospital Universitario Fundación Alcorcón, Alcorcón

Hospital General Universitario Santa Lucía, Cartagena

Hospital Costa del Sol, Marbella

Hospital de la Santa Creu i Sant Pau, Barcelona

Hospital Universitario Vall d'Hebron, Barcelona

Institut Català d'Oncologia, Barcelona

Hospital Universitario de Burgos, Burgos

Hospital Universitario Ramon y Cajal, Madrid

MD Anderson Cancer Center, Madrid

Hospital Universitario Clinico de Salamanca, Salamanca

Hospital Universitario Virgen del Rocio, Seville

Hospital Clínico de Valencia, Valencia

08036

Hospital Clínic de Barcelona, Barcelona

All Listed Sponsors
collaborator

Janssen-Cilag, S.A.

INDUSTRY

lead

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

OTHER

NCT02682641 - Ibrutinib in Combination With Rituximab in Patients With Indolent Clinical Forms of MCL | Biotech Hunter | Biotech Hunter