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Trial ID CA073-1020  |   NCT06356129

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

Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb Company

Summary

  • Phase 3
  • Male and Female Gender icon
  • 18-80
    Age Range
  • 157
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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).

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • 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:
    1. Diffuse large B-cell lymphoma (DLBCL), not otherwise specified [including germinal center B-cell (GCB) and activated B-cell (ABC) types]
      1. High-grade B-cell lymphoma, with MYC and BCL2 rearrangements (HGBL-MYC/BCL2 double-hit lymphomas)
        1. High-grade B-cell lymphoma, not otherwise specified
          1. T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL)
            1. Epstein-Barr virus + DLBCL
            2. 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.
              1. 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.
                1. Must have Ann Arbor Stage II-IV disease.

                  Exclusion Criteria

                  Exclusion Criteria Icon
                  :
                  • Any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
                    1. 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.
                      1. Documented or suspected central nervous system (CNS) involvement by lymphoma.
                        Additional Information *
                        • Other protocol-defined Inclusion/Exclusion criteria apply.

                          Treatment Options

                          Study Arms

                          ASSIGNED INTERVENTION

                          Study Arms

                          Experimental: Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)

                          ASSIGNED INTERVENTION

                          Study Arms

                          Placebo Comparator: Placebo + R-CHOP

                          ASSIGNED INTERVENTION
                          • Drug: Placebo, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
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