Evaluating Rituximab and R-EPOCH Treatment with ctDNA Monitoring in High-Risk B-Cell Posttransplant Lymphoproliferative Disorder

What this Trial Is About

Researchers are evaluating the benefit of adding rituximab to a chemotherapy regimen called R-EPOCH for people with high-risk B-cell posttransplant lymphoproliferative disorder PTLD during the second phase of treatment. Those with low-risk disease will receive rituximab alone without chemotherapy. The study also aims to assess circulating tumor DNA ctDNA, a new blood test that may help guide treatment decisions and personalize therapy to reduce side effects while maintaining effectiveness. The study is a phase 2, multi-center, open-label trial involving two groups based on risk. Low-risk participants receive four cycles of intravenous rituximab every 21 days. High-risk participants receive four cycles of dose-modified R-EPOCH chemotherapy every 21 days, which includes rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin with specific dosing schedules over several days. The study also uses a device for next-generation sequencing of ctDNA to monitor treatment response. Participants will have scans such as PET-CT or CT before joining and undergo various assessments including blood tests for ctDNA, organ and cardiac function tests, and performance status evaluations. Researchers will monitor treatment response, including complete response rates and progression-free survival over up to three years. Safety and tolerability will be tracked, and participants will be followed regularly during and after treatment to evaluate outcomes and side effects.

Defining ctDNA Metrics in Posttransplant Lymphoproliferative Disorder (PTLD)