NCT02417285 - A Phase 1b Open-label Study to Evaluate the Safety and Efficacy of CC-122 With Obinutuzumab (GA101) in Relapsed/Refractory DLBCL and iNHL. | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 22, 2015

Primary Completion Date

May 27, 2019

Study Completion Date

September 28, 2023

Conditions

Lymphoma, Large B-Cell, DiffuseLymphoma, Non-Hodgkin

Interventions

DRUG

Obinutuzumab

1000 mg administered IV on Days 2, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 though 8.

DRUG

CC-122

CC-122 1mg, 2mg, 3mg, 4mg or 5mg administered orally once daily on a 5/7-day schedule in each 28-day cycle. In addition, subjects will be enrolled on the CC-122 formulated capsule (F6) and evaluated for safety and tolerability in combination with GA101 (Obinituzumab) in a separate cohort. The CC-122 dose will be escalated until the MTD is established on the CC-122 formulated capsule (F6) in combination with GA101 (Obinituzumab).

Trial Locations (8)

1105

Local Institution - 201, Amsterdam

10126

Local Institution - 302, Torino

13273

Local Institution - 102, Marseille

33076

Local Institution - 105, Borddeaux Cedex

40138

Local Institution - 301, Bologna

69495

Local Institution - 103, Pierre-Bénite

94805

Local Institution - 101, Villejuif

3075 EA

Local Institution - 202, Rotterdam