Evaluating Ultra-Low-Dose Total Skin Electron Beam Therapy Combined with Brentuximab Vedotin Every Three Months for Adults with Mycosis Fungoides

What this Trial Is About

Researchers are evaluating whether combining ultra-low-dose total skin electron beam therapy ULD-TSEBT with the drug brentuximab vedotin can help control mycosis fungoides, a type of skin lymphoma affecting adults with stages I to IV of the disease. This phase 2 study also aims to understand the treatments safety, impact on neuropathy, quality of life, and survival outcomes, while exploring tumor and blood markers that may predict response to therapy. Participants receive radiation therapy applied to the entire skin surface over two days, with each treatment lasting about 60 to 90 minutes, alongside brentuximab vedotin given intravenously every three months for up to 12 months. The study follows patients for an average of one year to assess overall response rate and continues monitoring for up to two and a half years to evaluate complete response, progression-free survival, and overall survival. During the study, participants undergo various assessments including biopsy and blood tests to monitor tumor markers and immune responses. Researchers also track neuropathy symptoms using standard criteria and measure quality of life through validated questionnaires. Safety and treatment effects are carefully observed throughout the treatment period and follow-up, with the entire participation lasting over two years from enrollment to final evaluation.

Effectiveness of Concurrent Ultra-Low-Dose Total-Skin Electron Beam Therapy and Brentuximab Vedotin Given Quarterly Over 12 Months for Patients With Mycosis Fungoides