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 (GOLSEEK-1)
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 (GOLSEEK-1)
ClinicalTrials.gov ID: NCT06356129
Sponsor: Celgene
Information provided by: Celgene (Responsible Party)
Last Update Posted: 2024-04-10
Brief 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).
Official Title:
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)
Intervention / Treatment:
- Drug: Golcadomide
- Drug: Placebo
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Prednisone
| Category | Value |
|---|---|
| Study Start (Estimated) | 2024-06-24 |
| Primary Completion (Estimated) | 2028-08-14 |
| Study Completion (Estimated) | 2029-11-20 |
| Enrollment (Estimated) | 850 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
CA073-1020
2023-510178-15 (Registry Identifier) (REGISTRY: EU CT Number) U1111-1300-8493 (Registry Identifier) (REGISTRY: UTN) |