Phase II Study of Mogamulizumab and Extracorporeal Photopheresis to Treat Erythrodermic Cutaneous T Cell Lymphoma

What this Trial Is About

Researchers are evaluating a combination treatment using extracorporeal photopheresis ECP and mogamulizumab for patients with erythrodermic cutaneous T cell lymphoma CTCL, a rare skin cancer affecting white blood cells called T cells. This phase II trial aims to assess the tolerability and overall response rate of this combination in patients who have not previously received mogamulizumab. The study also explores quality of life, immune response effects, and survival outcomes with this therapy. Patients receive mogamulizumab intravenously over 60 minutes on days 1, 8, 15, and 22 of the first treatment cycle, then on days 1 and 15 of subsequent cycles. Starting with cycle 2, extracorporeal photopheresis is performed over about 3 hours on days 8, 9, 22, and 23. Each treatment cycle lasts 28 days, with up to 6 cycles given if there is no disease progression or unacceptable side effects. Patients who respond after 6 cycles may receive up to 6 more cycles under the same conditions. Participants will undergo assessments including skin biopsies, blood tests, and quality of life questionnaires before, during, and after treatment. Researchers will monitor treatment response, survival, side effects, and immune effects for up to one year following treatment. Follow-up visits occur 30 days after treatment completion and continue for up to 12 months to observe long-term effects and safety.

Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma