Large B-cell Lymphoma Clinical Trial
Official title:
Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma
To learn if adding epcoritamab to the treatment combination R-miniCVP (rituximab, cyclophosphamide, vincristine, prednisone) can help to control newly diagnosed DLBCL. The safety of this combination will also be studied.
Primary Objectives: --To determine the efficacy of epcoritamab in combination with R-miniCVP as determined by CR rate after six cycles of combination treatment for elderly/unfit patients or patients with heart failure with previously untreated DLBCL. Secondary Objectives --To determine best overall response rate (ORR), duration of response, progression-free survival (PFS), overall survival (OS), and evaluation of safety of epcoritamab in combination with R-miniCVP as treatment for elderly/unfit patients or patients with heart failure with previously untreated DLBCL. Exploratory Objectives: - To determine the biomarkers of response and mechanisms of resistance to epcoritamab in combination with R-miniCVP in DLBCL. - To determine the quality of life in patients with DLBCL receiving epcoritamab in combination with R-miniCVP ;
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