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Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

  • Clinical Trial Information

    Trial Contact: Donaldson, Karin M; Djuro, Victor

    Trial Phone: 321.841.9821 ; 321.841.7477

  • IRB No: PRO00071743

    Protocol Abbrev: M20-621

    Principal Investigator: Jose E. Sarriera, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: M20-621 (2021-000168-31)

    ClinicalTrials.gov ID: NCT05578976

  • Objective

    The primary objective of this study is to evaluate whether the addition of epcoritamab to 6 cycles of standard R-CHOP followed by 2 cycles of epcoritamab (E + R-CHOP) can prolong PFS compared with
    6 cycles of standard R-CHOP followed by 2 cycles of rituximab (R-CHOP) in subjects with newly diagnosed DLBCL with an IPI of 3-5.
    Hypothesis corresponding to the primary efficacy objective: E + R-CHOP improves PFS compared to
    R-CHOP in subjects with newly diagnosed DLBCL with an IPI of 3-5.

  • Key Eligibility

    Inclusion Criteria:
    •   Planned to receive treatment with 6 cycles of standard rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) per investigator determination.
    •   Must have newly diagnosed, histologically confirmed CD20+ diffuse large b-cell lymphoma [DLBCL] (de novo or histologically transformed from a diagnosis of follicular lymphoma) at most recent representative tumor biopsy based on the pathology report, with a World Health Organization (WHO) 2016 classification and including:
    o DLBCL, Not Otherwise Specified (NOS).
    o High grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology.
    o T-cell/histiocyte-rich large B-cell lymphoma.
    o Epstein Barr virus-positive DLBCL, NOS.
    o Follicular lymphoma Grade 3b.
    Note: The local pathology report must be available at Screening to support CD20+ DLBCL histology.
    Composite/intermediate histology with any of the following components is not allowed: high grade B-cell lymphoma, NOS; Hodgkin's lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt; plasmablastic lymphoma or any CD20- lymphoma, such as anaplastic lymphoma kinase-positive large B-cell lymphoma, human herpesvirus type 8-positive DLBCL, or primary effusion lymphoma.
    •   Availability of archival or freshly collected tumor tissue at Screening. Archival paraffin-embedded tissue must be obtained within 8 weeks prior to Cycle 1 Day 1.
    •   Must have an IPI score of 2-5. The number of participants with IPI 2 will not exceed approximately 30% of the overall sample size.
    •   Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 prior to initiating R-CHOP treatment. Note that participant with an initial ECOG performance status >= 3 may be screened if pre-phase treatment is planned. Participant may be eligible if ECOG performance status were to improve to 0-2 during pre-phase treatment.
    •   Has at least one target lesion defined as:
    o >= 1 measurable nodal lesion (long axis > 1.5 cm ) or >= 1 measurable extra-nodal lesion (long axis > 1 cm) on computed tomography (CT) scan or magnetic resonance imaging (MRI). AND
    o Positron emission tomography (PET)-positive on PET-CT scan.
    •   Laboratory values meeting the criteria laid out in the protocol.
    •   Left ventricular ejection fraction must be >= 50% by multi-gated acquisition or transthoracic echocardiography at Screening.
    Exclusion Criteria:
    •   History of prior systemic anti-lymphoma therapy for diagnosed diffuse large b-cell lymphoma (DLBCL) including any definitive radiotherapy with curative intent] other than corticosteroids with or without vincristine during prephase treatment, or non-curative intent palliative radiotherapy with the stipulation that radiated lesions cannot be selected as target lesion for response assessment.
    •   Clinically significant cardiovascular disease as per the protocol.