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)
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)
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).
Inclusion Criteria
- 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:
i) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified [including germinal center B-cell (GCB) and activated B-cell (ABC) types]
ii) High-grade B-cell lymphoma, with MYC and BCL2 rearrangements (HGBL-MYC/BCL2 double-hit lymphomas)
iii) High-grade B-cell lymphoma, not otherwise specified
iv) T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL)
v) Epstein-Barr virus + DLBCL
Exclusion Criteria
Bogota, Cundinamarca 111151, Colombia
Saint Priest En Jarez, Pays de la Loire Region 42271, France
New Town, West Bengal 700160, India
Eiheiji-cho,Yoshida-gun, Fukui 910-1193, Japan
Nagaizumi-cho,Sunto-gun, Shizuoka 411-8777, Japan
Bunkyo-ku, Tokyo 113-8431, Japan
Itabashiku, Tokyo 173-8610, Japan
Lembah Pantai, Kuala Lumpur 59100, Malaysia
Ampang, Selangor 68000, Malaysia
Tg.Mures, Mureș County 540136, Romania
Deagu, Taegu-Kwangyǒkshi 41404, South Korea
L'Hospitalet Del Llobregat, Barcelona [Barcelona] 08908, Spain
El Palmar, Murcia, Murcia, Región de 30120, Spain