Phase II Study of Extracorporeal Photopheresis Treatment in Adults With Sezary Syndrome Evaluating Changes in Tumor Immunity and Skin Tumor Burden

What this Trial Is About

Researchers are evaluating how extracorporeal photopheresis ECP affects tumor cells and immune responses in patients with Sezary Syndrome, a severe form of cutaneous T-cell lymphoma that rapidly worsens and has limited treatment options. This study aims to understand changes in the tumor environment and immune system after ECP, using advanced techniques like single-cell RNA sequencing to analyze blood samples and correlate findings with clinical outcomes. The study is led by Oleg E. Akilov, MD, PhD, and focuses on improving knowledge about immune responses in this condition. Participants will receive ECP treatment once a week for four weeks and then every two weeks for five months. ECP involves collecting white blood cells and plasma, exposing them to a light-sensitizing drug called methoxsalen, and returning them to the body. During the study, patients will provide blood samples at five time points to assess immune changes, and clinical assessments will include skin tumor burden measurement, flow cytometry of blood, and CT scans at baseline and as needed. Throughout the trial, researchers will monitor tumor-specific immunity and objective treatment responses up to six months after starting ECP. Assessments include skin weighted evaluation, blood tests, and imaging to detect disease progression. Participants will be observed closely, with blood and tissue samples collected to study molecular changes. The total study duration covers initial treatment and follow-up, with safety and disease status tracked regularly.

Extracorporeal Photopheresis in Sezary Syndrome