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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
Trial Status: active
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
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.
Exclusion Criteria
Any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
Any 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.
Documented or suspected central nervous system (CNS) involvement by lymphoma.
Other protocol-defined Inclusion/Exclusion criteria apply.
Additional locations may be listed on ClinicalTrials.gov for NCT06356129.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not Available
Florida
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available
Tampa
Moffitt Cancer Center
Status: Active
Name Not Available
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not Available
Iowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Active
Name Not Available
Kansas
Kansas City
University of Kansas Cancer Center
Status: Active
Name Not Available
Michigan
Ann Arbor
University of Michigan Comprehensive Cancer Center
