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RECRUITING
NCT05157581

Extracorporeal Photopheresis in Sezary Syndrome

Sponsor: Oleg E. Akilov, MD, PhD

View on ClinicalTrials.gov

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

DEVICE

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.

DRUG

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