Phase 2 Trial of Mogamulizumab Combined with Low-Dose Total Skin Electron Beam Therapy for Mycosis Fungoides and Szary Syndrome

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining low-dose total skin electron beam therapy LD-TSEBT with the drug mogamulizumab in patients diagnosed with Mycosis Fungoides MF and Szary Syndrome SS. This Phase 2 study aims to determine how well this combination works and to assess its clinical benefits and tolerability for these conditions. Participants receive mogamulizumab intravenously at 1 mgkg with a specific schedule during the first 28-day cycle, doses are given on days 1, 8, 15, and 22 for subsequent cycles, doses are administered on days 1 and 15. LD-TSEBT, a form of radiation therapy delivering a total skin dose of 12 Gy over 2 to 3 weeks, starts on the second day of the first mogamulizumab cycle. The radiation is fractionated at 4 to 6 Gy per week as tolerated. Throughout the study, participants undergo regular assessments including evaluations of overall response rate at 12 months, progression-free survival, duration of response, time to next significant treatment, quality of life, and treatment-related adverse events. Safety and tolerability are closely monitored. The study duration extends up to three years for some outcome measures, with ongoing monitoring to evaluate both clinical benefits and potential risks.

Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome