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) chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphomacancers of the lymphatic system (LBCL).
Intervention / Treatment
- Drug: Golcadomide
- Drug: Placebo
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Prednisone
Inclusion Criteria:
– Histologically confirmed (per local evaluation) diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results 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
- International 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.
- Measurable 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 imagingtests that create detailed images of areas inside the body (MRI), as defined by the Lugano classification.
- Must have Ann Arbor Stage II-IV disease.