Trials / Recruiting
RecruitingNCT06911502
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)
A Phase 3, Multicenter, Randomized, Open Label 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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- Celgene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Golcadomide | Specified dose on specified days |
| DRUG | Rituximab | Specified dose on specified days |
| DRUG | Lenalidomide | 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/Prednisolone | Specified dose on specified days |
| DRUG | Bendamustine | Specified dose on specified days |
Timeline
- Start date
- 2025-07-28
- Primary completion
- 2028-04-24
- Completion
- 2030-07-31
- First posted
- 2025-04-04
- Last updated
- 2025-12-05
Locations
160 sites across 21 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06911502. Inclusion in this directory is not an endorsement.