Study of Epcoritamab with Intensive Salvage Chemotherapy Followed by Stem Cell Transplant and Epcoritamab Consolidation in Adults with Relapsed Large B-cell Lymphoma

What this Trial Is About

Researchers are evaluating the clinical effectiveness of adding Epcoritamab to the salvage treatment routine for patients with relapsed or refractory aggressive B-cell lymphoma. The study aims to determine if Epcoritamab combined with intensive salvage chemotherapy is safe and improves the rate of complete remission before autologous stem-cell transplantation ASCT. It also assesses the safety and deliverability of consolidation Epcoritamab after ASCT and whether this approach improves disease clearance and progression-free survival at 12 months compared to historical data. The treatment plan includes three phases first, a salvage treatment combining three cycles of R-DHAOx chemotherapy rituximab, dexamethasone, cytarabine, oxaliplatin with weekly subcutaneous doses of Epcoritamab second, autologous stem-cell transplantation administered locally following standard procedures and third, a consolidation phase of six 28-day cycles of subcutaneous Epcoritamab starting 6 to 12 weeks after ASCT. The Epcoritamab dosing escalates from low priming doses to full doses during both salvage and consolidation phases. Participants will be monitored throughout the study with assessments including response rates, survival outcomes, and safety evaluations at specific time points such as before and after ASCT and during follow-up visits up to 24 months. Researchers will use imaging and clinical tests to measure disease status and treatment effects. The main outcome measured is event-free survival at 12 months, alongside other measures like overall response, complete response, overall survival, and progression-free survival.

Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL