Actively Recruiting
Extracorporeal Photopheresis in Sezary Syndrome
Led by Oleg E. Akilov, MD, PhD · Updated on 2025-12-30
20
Participants Needed
3
Research Sites
295 weeks
Total Duration
On this page
Sponsors
O
Oleg E. Akilov, MD, PhD
Lead Sponsor
T
Therakos
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Extracorporeal Photopheresis in Sezary Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Established diagnosis of Sezary syndrome (stage IVA1)
- Amenable to extracorporeal photopheresis (ECP)
- Minimum wash-out period of 3 weeks since last systemic therapy
- Recovery from all adverse events related to prior therapy to grade 1 or less
- Signed informed consent before any protocol-specific procedures
You will not qualify if you...
- Presence of visceral metastasis of lymphoma
- Receiving radiotherapy or systemic anti-cancer therapy during the study
- Active systemic or skin infections of grade 3 or higher severity
- Serious medical conditions that impair ability to receive or tolerate treatment or comply with protocol
- Dementia or altered mental status preventing informed consent
- Known allergy to methoxsalen or heparin
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
2
Cutaneous Translational Research Program - Johns Hopkins Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
3
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
C
Charity Ruhl, LPN
CONTACT
N
Nicolena Verardi, PA-C
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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