Carrie Ho, MD
A Phase II, open-label, two-arm, multicenter study evaluating the combination of epcoritamab with R-CHOP chemotherapy in patients with newly diagnosed, aggressive B-cell non-Hodgkin lymphoma.
PRIMARY OBJECTIVES: I. To evaluate the incidence and severity of all grade CRS cytokine release syndrome (CRS) in arm A and arm B. SECONDARY OBJECTIVES: I. To determine the safety and tolerability of the combination of epcoritamab and rituximab, cyclophosphamide, hydroxydaunorubicin, oncovin, prednisolone (R-CHOP) in both arms and individually. II. The anti-tumor activity of epcoritamab + R-CHOP. III. To evaluate duration of response (DOR), progression-free survival (PFS), and overall survival (OS). EXPLORATORY OBJECTIVES: I. To evaluate changes in serum cytokine levels with epcoritamab…
Inclusion Criteria: 1. Participants must have confirmed CD20-positive aggressive B-cell lymphoma, including de novo or transformed diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS); high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement; primary mediastinal large B-cell lymphoma (PMBCL); T-cell/histiocyte-rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus-positive DLBCL, NOS; or follicular lymphoma grade 3b. 2. Measurable disease per Lugano 2014 criteria. 3. No prior therapy for DLBCL or FL G3B other than corticosteroids or palliative radiotherapy. Of…
Given orally and intravenously (IV)
Given subcutaneously (SC)
Given orally
Undergo imaging
Perform Blood work
Participants complete European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Undergo Imaging
Arctuva estimate
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