Phase 2 Study of Epcoritamab with Rituximab, Gemcitabine, and Oxaliplatin as Salvage Therapy Before Stem Cell Transplant in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

What this Trial Is About

Researchers are studying a treatment approach for adults with relapsed or refractory diffuse large B-cell lymphoma DLBCL who are eligible for stem cell transplant but whose cancer has not responded well to prior therapies. The trial evaluates epcoritamab combined with rituximab, gemcitabine, and oxaliplatin R-GemOx given as salvage therapy before autologous stem cell transplant ASCT. Epcoritamab is a bispecific antibody designed to bring immune T cells and lymphoma cells together to help the immune system target the cancer. Participants receive epcoritamab by subcutaneous injection on specific days during each 14-day cycle along with R-GemOx chemotherapy on day 1 for up to three cycles, with the option for one additional cycle depending on response. After salvage therapy, eligible patients undergo ASCT. Those who respond but cannot have ASCT may receive consolidation therapy with epcoritamab over several 28-day cycles to further treat the lymphoma. Throughout the study, participants will have blood samples taken and imaging scans including PETCT to monitor response. Bone marrow biopsies and tissue biopsies may also be performed as needed. After treatment, follow-up visits occur at 30 and 60 days, then at 12 and 24 months to assess treatment outcomes such as complete response and survival, as well as monitor side effects and overall health.

Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma