RecruitingNCT05157581

Extracorporeal Photopheresis in Sezary Syndrome

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

Sponsor

Oleg E. Akilov, MD, PhD

Enrollment

20 participants

Start Date

Apr 4, 2023

Study Type

OBSERVATIONAL

Conditions

Sezary Syndrome

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 ).

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a treatment called extracorporeal photopheresis (ECP) for people with Sézary syndrome — a rare and aggressive form of blood cancer that affects the skin. ECP is a procedure where blood is drawn, treated with light-activated medicine, and returned to the body. **You may be eligible if...** - You have been diagnosed with Sézary syndrome (stage IVA1) - It has been at least 3 weeks since your last systemic (whole-body) treatment - You have recovered from the side effects of prior treatments - You are able to safely undergo the ECP procedure **You may NOT be eligible if...** - Your lymphoma has spread to internal organs - You are currently receiving radiation therapy or other cancer treatments - You have a serious active infection (viral, bacterial, or fungal) - You have dementia or are unable to understand and consent to the study - You are allergic to methoxsalen or heparin - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEExtracorporeal 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.

DRUGMethoxsalen 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

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NCT05157581

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