πŸ›οΈ Verified NIH Record β€’ Updated 2025-12-23

Extracorporeal Photopheresis in Sezary Syndrome (NCT05157581)

Open Label, Single-cohort, and Multi-center Phase II Study Evaluating Tumor-specific Immunity After Extracorporeal Photopheresis in Patients With SΓ©zary Syndrome at Single-cell Resolution

🟒 Recruiting Interventional Protocol πŸ“Š Observational Clinical Research Sponsor: Oleg E. Akilov, MD, PhD

🩺 Plain-English Summary (8th-Grade Level)

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 ).

Who can join: Review the eligibility criteria below.

Location: Emory University School of Medicine β€” Atlanta, Georgia

Age range: 18 Years to 100 Years

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (3 Sites)

  • Emory University School of Medicine β€” Atlanta, Georgia
  • Cutaneous Translational Research Program - Johns Hopkins Medicine β€” Baltimore, Maryland
  • University of Pittsburgh Medical Center β€” Pittsburgh, Pennsylvania

πŸ“ž Contact the Study Coordinator

Phone: (412) 647-2013

Email: ruhlcl@upmc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Sezary Syndrome clinical trials

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—