A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Choice in Participants With Relapsed/Refractory Follicular Lymphoma Who Have Received at Least 1 Prior Line of Systemic Therapy (GOLSEEK-4)
NCT06911502 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2026-05-20
Summary
The study is designed as a multicenter, randomized, open label Phase 3 study to compare the efficacy and safety of golcadomide in combination with rituximab vs investigator's choice in participants with relapsed/refractory follicular lymphoma who have received at least one line of prior systemic therapy.
Conditions
Interventions
- DRUG
-
Golcadomide
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Doxorubicin
Specified dose on specified days
- DRUG
-
Vincristine
Specified dose on specified days
- DRUG
-
Prednisone/Prednisolone
Specified dose on specified days
- DRUG
-
Specified dose on specified days
Sponsors & Collaborators
-
Celgene
lead INDUSTRY
Principal Investigators
-
Bristol Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-28
- Primary Completion
- 2028-04-24
- Completion
- 2030-07-31
- FDA Drug
- Yes
Countries
- United States
- Australia
- Brazil
- Canada
- Chile
- China
- Finland
- France
- Germany
- Greece
- India
- Italy
- Japan
- Netherlands
- Poland
- Saudi Arabia
- South Korea
- Spain
- Turkey (Türkiye)
- United Arab Emirates
- United Kingdom
Study Locations
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