USO 22041
A Phase 2, Open-Label Trial to Evaluate Safety of Epcoritamab monotherapy in Subjects with Relapsed or Refractory Diffuse Large B-cell Lymphoma and Classic Follicular Lymphoma (Previously Grade 1-3a) when Administered in the Outpatient Setting (M23-362)
Disease Types: Lymphoma & Hematologic
Eligibility Requirements:
Inclusion Criteria:
Diagnosis of Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) or R/R Follicular Lymphoma (FL) grade 1, 2, or 3a, with documented CD20+ mature B-cell neoplasm according to World Health Organization (WHO) classification 2016 or WHO classification 2008 based on representative pathology report:
Participants with double-hit or triple-hit DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations). Note: Other double-/triple-hit lymphomas are not eligible.
Relapsed or refractory disease and previously treated with at least 2 prior systemic antineoplastic therapies including at least 1 anti-CD20 monoclonal antibody-containing therapy.
Must have 1 or more measurable disease sites:
Fluorodeoxyglucose (FDG)-avid lymphomas: Measurable disease with computerized tomography (CT) (or magnetic resonance imaging [MRI]) scan with involvement of 2 or more clearly demarcated lesions/nodes with a long axis > 1.5 cm and short axis > 1.0 cm (or 1 clearly demarcated lesion/node with a long axis > 2.0 cm and short axis > 1.0 cm) AND FDG positron emission tomography (PET) scan demonstrating positive lesion(s) compatible with CT (or MRI) defined anatomical tumor sites.
FDG-nonavid lymphomas: Measurable disease with CT (or MRI) scan with involvement of 2 or more clearly demarcated lesions/nodes with a long axis > 1.5 cm and short axis > 1.0 cm or 1 clearly demarcated lesion/node with a long axis > 2.0 cm and short axis > 1.0 cm.
Must have Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
Adequate organ function.
Exclusion Criteria:
Central nervous system (CNS) involvement.
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