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Extracorporeal Photopheresis in Sezary Syndrome
Sponsor: Oleg E. Akilov, MD, PhD
Summary
The primary endpoint is to determine if ECP induces a decrease in % of tumor cells after treatment. 20 patients with Sezary Syndrome will receive ECP weekly x4, then bi-weekly for 5 months. Each patient will donate 5 samples to determine immune responses in peripheral blood. Additional clinical assessments will be a modified skin weighted assessment and flow cytometry at baseline and months 3 and 6. A CT scan will be obtained at baseline and only repeated if pathology is present at baseline. The tumor microenvironment will be studied by comparing transcriptomics of the blood samples before, 1 day after first ECP treatment, cycle 1, 1, 3 and 6 months after ECP treatment by scRNAseq (5 samples total per patient ).
Official title: Open Label, Single-cohort, and Multi-center Phase II Study Evaluating Tumor-specific Immunity After Extracorporeal Photopheresis in Patients With Sézary Syndrome at Single-cell Resolution
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
OBSERVATIONAL
Enrollment
20
Start Date
2023-04-04
Completion Date
2028-12
Last Updated
2025-12-30
Healthy Volunteers
No
Conditions
Interventions
Extracorporeal photopheresis (ECP)
Extracorporeal photopheresis is a process that exposes a collection of white blood cells and plasma to a light sensitizing agent, methoxsalen, and returns that compartment to the body.
Methoxsalen Injection
Methoxsalen is a light-sensitizing sterile compound added to the collected white blood cells and plasma during ECP.
Locations (3)
Emory University School of Medicine
Atlanta, Georgia, United States
Cutaneous Translational Research Program - Johns Hopkins Medicine
Baltimore, Maryland, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States