Conditions: Diffuse Large Cell B-lymphoma
Keywords: PCI-32765 Lymphoma, B-Cell Bruton's Tyrosine Kinase Non Hodgkin's Lymphoma Germinal Center B-Cell Activated B-Cell
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 78
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy of ibrutinib (PCI-32765) in relapsed/refractory de novo activated B-cell (ABC) and germinal-cell B-Cell (GCB) Diffuse Large B-cell Lymphoma (DLBCL).

Detailed description:
The primary objectives of this study were to evaluate the efficacy of ibrutinib administered at 560 mg once per day in relapsed or refractory de novo ABC and GCB DLBCL, and to evaluate the efficacy of ibrutinib administered at 840 mg once per day in relapsed or refractory de novo ABC DLBCL.

The secondary objective was to evaluate the safety and tolerability of a fixed daily oral dosing regimen of ibrutinib in relapsed/refractory de novo DLBCL.

Arms:
arm 1: Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis. arm 2: Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.

Interventions: intervention 1: ibrutinib
Intervention descriptions: intervention 1: ibrutinib is an inhibitor of BTK

Protocol document: