NCT02031419

Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-cell Lymphoma and Follicular Lymphoma

A Phase 1B, Multi-Center, Open-Label Study of Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-Cell Lymphoma and Follicular Lymphoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

First study, at multiple clinical centers, exploring the effects of different combinations of compounds (CC-122, CC-223 ,CC-292 and rituximab) to treat Diffuse Large B Cell Lymphoma (DLBCL) and Follicular Lymphoma

Detailed description

Study CC-122-DLBCL-001 is a Phase 1b dose escalation and expansion clinical study of CC 122, CC-223 and CC-292 administered orally as doublets with or without rituximab, in participants with relapsed/refractory DLBCL who have failed standard therapy. In expansion phase, selected combination will be administered to lenalidomide naïve FL participants and lenalidomide exposed FL participants in addition to relapsed/refractory DLBCL participants.

Conditions

• Lymphoma, Large B-Cell, Diffuse

Interventions

Type	Name	Description
DRUG	CC-122	2mg or 3 mg administered orally once daily
DRUG	CC-223	20mg or 30mg administered orally once daily.
DRUG	Rituximab	375 mg/m2 administered intravenously once every 28 days
DRUG	CC-122	2mg or 3mg administered orally once daily.
DRUG	CC-292	500 mg twice a day administered orally.
DRUG	Rituximab	375 mg/m2 administered intravenously once every 28 days
DRUG	CC-223	20mg or 30mg per day administered orally daily.
DRUG	CC-292	500 mg twice a day administered orally.
DRUG	Rituximab	375 mg/m2 administered intravenously once every 28 days

Timeline

• Start date: 2013-12-18
• Primary completion: 2023-12-12
• Completion: 2023-12-12
• First posted: 2014-01-09
• Last updated: 2024-01-18

Locations

16 sites across 4 countries: United States, Canada, France, Italy