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
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
18 - 80 Years, Male and Female
CA073-1020 (primary)
NCI-2024-05249
2023-510178-15
U1111-1300-8493
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).
Eligibility
- 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
- 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 imaging (MRI), as defined by the Lugano classification.
- Must have Ann Arbor Stage II-IV disease.
Treatment Sites in Georgia
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