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Clinical Trials | A Phase II trial Evaluating Safety and Efficacy of Epcoritamab with Gemcitabine, Dexamethasone, and Cisplatin (GDP) Salvage Chemotherapy in Relapsed Refractory Large B-cell Lymphoma.

A Phase II trial Evaluating Safety and Efficacy of Epcoritamab with Gemcitabine, Dexamethasone, and Cisplatin (GDP) Salvage Chemotherapy in Relapsed Refractory Large B-cell Lymphoma.

The University of Virginia seeks adults ages 18 and over with Relapsed Refractory Large B-cell Lymphoma for a research study. The purpose of this research study is to see if adding a drug called epcoritamab to “salvage chemotherapy” (gemcitabine + cisplatin, with dexamethasone) will better treat your cancer than using chemotherapy alone. If you choose to participate in this study, you will receive epcoritamab (the study drug) in combination with the GDP chemotherapy regimen for Cycles 1 to 3. Epcoritamab (the study drug) is given as an injection under the skin in the clinic on Days 1, 8 and 15 of Cycles 1 to 3. The chemotherapy regimen consists of three medications: gemcitabine, dexamethasone and cisplatin. Gemcitabine and cisplatin are given as IV infusions in the clinic on Day 1 of Cycles 1 to 3. Gemcitabine will also be given on Day 8 of Cycles 1 to 3. Dexamethasone is given as a pill to be taken orally on Days 1-4. After 3 Cycles of combination treatment, you will have radiology imaging to see how your disease has responded. Your doctor will talk with you about the option of (1) having an allogenic or autologous stem cell transplant or (2) CAR-T cell therapy or (3) continuing epcoritamab treatment alone for 6 more cycles (Cycles 4-9). You will receive study treatment for about 1 year and then followed up with every 6 months for a total of 3 years. Study-related procedures that are being done as standard of care will be billed to you or your insurance.