drugset / Trial / NCT06954805

Defining ctDNA Metrics in Posttransplant Lymphoproliferative Disorder (PTLD)

NCT06954805

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to find out if there is a benefit to giving rituximab with etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin (R-EPOCH) in participants who have high-risk B-cell PTLD in their 2nd phase of treatment (consolidation) while those with low-risk disease will be spared of chemotherapy and treated with rituximab consolidation alone. This study is also being done to find out about the usefulness of circulating tumor DNA (ctDNA), a novel blood test which, has been shown to help guide treatment decisions in other types of lymphoma. The goal is to answer the question if ctDNA is a viable and informative tool in treating PTLD with the hope that in the future it may be used to individualize study treatment for participants with PTLD in a way that limits study treatment toxicity without losing the effectiveness of the treatment plan.

Timeline

Start
2025-04-14
Primary completion
2027-04-14
Completion
2028-04-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 375 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 10 mg/m2 Intravenous
Subject Etoposide Small molecule 50 mg/m2 Intravenous
Subject Prednisone Other / unclassified 60 mg/m2 Oral
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Vincristine Small molecule 0.4 mg/m2 Intravenous