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.

A Phase 1b Open-label Study to Evaluate the Safety and Efficacy of CC-122 in Combination With Obinutuzumab (GA101) in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Indolent Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

CC-122-NHL-001 study is a multicenter, open-label, phase Ib study with dose escalation and expansion parts. It evaluates the safety, tolerability and clinical pharmacokinetics of CC-122 in combination with obinutuzumab (GA101). The study is also assessing the preliminary efficacy of the combination as well as pharmacodynamic and tumor biomarkers as exploratory objectives. In the dose escalation part, the safety and tolerability of increasing doses of CC-122 administered with a fixed dose of obinutuzumab will be administered to identify the maximum tolerated dose. In the dose expansion part, more patients will be enrolled at a CC-122 dose selected from the escalation part of the study in combination with fixed dose obinutuzumab to further study safety and efficacy.

Detailed description

The one or two cohorts during the dose expansion phase (Part B) will enroll subjects with relapsed or refractory follicular lymphoma (FL) who were either refractory to or relapsed after treatment with a lenalidomide-containing regimen (FL-1 cohort) or never been exposed to lenalidomide (FL-2 cohort). The FL-1 and FL-2 cohorts will enroll up to 20 and/or up to 30 subjects, respectively.

Conditions

• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2015-05-22
• Primary completion: 2019-05-27
• Completion: 2023-09-28
• First posted: 2015-04-15
• Last updated: 2023-10-23

Locations

8 sites across 3 countries: France, Italy, Netherlands