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)
Primary:
To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to PFS as assessed by the
Investigator.
Secondary (efficacy):
To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to PFS as assessed by the IRAC.
To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to OR as assessed by the
Investigator.
To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to CMR as assessed by the
Investigator
To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants
with untreated high-risk large B-cell lymphoma with respect to PFS24.
To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants
with untreated high-risk large B-cell lymphoma with respect to DoR.
To evaluate the efficacy of treatment with golcadomide plus R-CHOP vs placebo-RCHOP
on overall survival in participants with untreated high-risk large B-cell lymphoma with respect to PFS2.
To evaluate the exposure of CHOP cytotoxic components (cyclophosphamide, doxorubicin,
vincristine) in golcadomide plus R-CHOP vs placebo plus R-CHOP in participants with
untreated high-risk large-B-cell lymphoma with respect to relative dose intensity (RDI).
To compare the disease symptoms, functioning, and overall HRQoL of golcadomide plus R-CHOP vs placebo-RCHOP in participants with untreated high-risk large B-cell lymphoma as measured by the EORTC QLQ-C30 and the FACT-LymS
Secondary (Safety):
To evaluate the safety of golcadomide plus RCHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma.
- RWJBarnabas Health
- Community Medical Center
- Cooperman Barnabas, Livingston
- Monmouth Medical Center
- Rutgers University
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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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