NCT06356129

Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Golcadomide Plus R-CHOP Chemotherapy vs Placebo Plus R-CHOP Chemotherapy in Participants With Previously Untreated High-risk Large B-cell Lymphoma (GOLSEEK-1)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 850 (estimated)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL).

Conditions

• Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Golcadomide	Specified dose on specified days
DRUG	Placebo	Specified dose on specified days
DRUG	Rituximab	Specified dose on specified days
DRUG	Cyclophosphamide	Specified dose on specified days
DRUG	Doxorubicin	Specified dose on specified days
DRUG	Vincristine	Specified dose on specified days
DRUG	Prednisone	Specified dose on specified days

Timeline

• Start date: 2024-06-19
• Primary completion: 2028-08-14
• Completion: 2029-11-20
• First posted: 2024-04-10
• Last updated: 2026-02-12

Locations

325 sites across 38 countries: United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study