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๐Ÿ›๏ธ Verified NIH Protocol โ€ข Sourced via U.S. National Library of Medicine (Last Synced: 2025-12-30)

Extracorporeal Photopheresis in Sezary Syndrome

๐ŸŸข Recruiting Not Applicable ๐Ÿ“Š Observational Clinical Research Sponsor: Oleg E. Akilov, MD, PhD

๐Ÿฉบ Protocol 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 ).

Primary Research Facility: Emory University School of Medicine (Atlanta, Georgia)

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๐Ÿ“ Primary Site Map

Site: Emory University School of Medicine โ€” Atlanta, Georgia

๐Ÿ“ All Participating Trial Locations (3 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. Emory University School of Medicine โ€” Atlanta, Georgia โ€ข Contact: (404) 778-6195
2. Cutaneous Translational Research Program - Johns Hopkins Medicine โ€” Baltimore, Maryland โ€ข Contact: (443) 856-7329
3. University of Pittsburgh Medical Center โ€” Pittsburgh, Pennsylvania โ€ข Contact: (412) 647-2013

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๐Ÿ’ฐ Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act ยง 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

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๐Ÿ›๏ธ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT05157581 โ€ข Last Synced: 2025-12-30
View on ClinicalTrials.gov โ†—
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