Epcoritamab in Combination With R-CHOP Debulking in Newly Diagnosed Patients With Aggressive Non-Hodgkin Lymphoma
Mwanasha Merrill, MD
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugRituximab, Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisolone (R-CHOP)
Given orally and intravenously (IV)
- DrugEpcoritamab
Given subcutaneously (SC)
- DrugDexamethasone
Given orally
- ProcedurePositron Emission Tomography (PET)
Undergo imaging
- ProcedureBlood specimen collection
Perform Blood work
- BehavioralQuestionnaires
Participants complete European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Locations (2)
- Zuckerberg San Francisco GeneralSan Francisco, California
- University of California, San FranciscoSan Francisco, California