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Extracorporeal Photopheresis in Sezary Syndrome

NCT05157581 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-12-30

No results posted yet for this study

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 ).

Conditions

  • Sezary Syndrome

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.

Sponsors & Collaborators

  • Therakos

    collaborator INDUSTRY

  • Oleg E. Akilov, MD, PhD

    lead OTHER

Principal Investigators

  • Oleg E Akilov, MD, PhD · University of Pittsburgh

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-04
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05157581 on ClinicalTrials.gov