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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)
Phase
Phase 3
Sponsor
Celgene
Enrollment
850
Timeline
Jun 2024 → Nov 2029
About This Study
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).
Eligibility Criteria
Inclusion Criteria
- 1\- Histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated large B-cell lymphoma (LBCL) according to 2022 world health organization (WHO) classification including:
- 2i) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified \[including germinal center B-cell (GCB) and activated B-cell (ABC) types\]
- 3ii) High-grade B-cell lymphoma, with MYC and BCL2 rearrangements (HGBL-MYC/BCL2 double-hit lymphomas)
- 4iii) High-grade B-cell lymphoma, not otherwise specified
- 5iv) T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL)
- 6v) Epstein-Barr virus + DLBCL
- 7International Prognostic Index (IPI) score 1 or 2 with lactate dehydrogenase (LDH) \> 1.3 x upper limit of normal (ULN) and/or bulky disease defined as single lesion of ≥ 7 cm OR IPI ≥ 3.
- 8Measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for FDG-avid subtype and 1 bi-dimensionally measurable (\> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification.
- 9Must have Ann Arbor Stage II-IV disease.
Exclusion Criteria
- 1Any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
- 2Any other subtype of lymphoma. Cases of primary mediastinal (thymic) large B-cell lymphoma (PMBCL), primary cutaneous DLBCL-leg type, Grade 3b FL, indolent lymphoma transformed to large B-cell lymphoma (LBCL), Anaplastic lymphoma kinase (ALK) positive large B-cell lymphoma, primary effusion lymphoma, and Burkitt lymphoma.
- 3Documented or suspected central nervous system (CNS) involvement by lymphoma.
Locations
344 sites participating in this study
Emory University School of Medicine- Grady Campus
Atlanta, Georgia 30303
Carlos Lopez, Site 0515
Winship Cancer Institute, Emory University
Atlanta, Georgia 30322
Carlos Lopez, Site 0303
USA Mitchell Cancer Institute
Mobile, Alabama 36604
Anita Mazloom, Site 0014
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →