Using THERAKOS CELLEX Photopheresis System to Treat Early Stage Cutaneous T-Cell Lymphoma An Open-label, Single-arm, Phase II Study

What this Trial Is About

Researchers are evaluating whether photopheresis therapy can improve the clinical course of early stage cutaneous T-cell lymphoma CTCL, specifically in patients with Mycosis Fungoides. This study focuses on stages IA, IB, or IIA CTCL, where some patients may have blood markers previously seen only in later stages. The goal is to investigate if using photopheresis earlier can produce a clinical response, expanding its current use beyond late-stage disease. Participants will receive treatment using the THERAKOS4 CELLEX Photopheresis System combined with UVADEX4 methoxsalen sterile solution. Treatment is given on two consecutive days every two weeks for the first three months, followed by once per month for nine months. This open-label, single-arm study assesses photopheresis therapy as an interventional treatment in early stage CTCL. During the study, participants will be monitored over one year with assessments including response to treatment, time to response, and duration of response. Patient-reported outcomes like the Functional Assessment of Cancer Therapy - General FACT-G, Skindex-29, and Short Form Survey SF-36v2 will be measured at baseline and one year. Researchers will also track changes in lymph node size and Szary cell counts at baseline, six months, and twelve months to evaluate safety and effectiveness.

Photopheresis in Early-stage Mycosis Fungoides