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Extracorporeal Photopheresis in Sezary Syndrome
NCT05157581 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DEVICE Extracorporeal photopheresis (ECP)
- DRUG Methoxsalen Injection
Study Locations (3)
Georgia
- Emory University School of Medicine — Atlanta
Maryland
- Cutaneous Translational Research Program - Johns Hopkins Medicine — Baltimore
Pennsylvania
- University of Pittsburgh Medical Center — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-04-04 |
| Est. Completion | 2028-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05157581
The ClinicalTrials.gov registry entry for NCT05157581 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oleg E. Akilov, MD, PhD, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Sezary Syndrome appearing as the primary indexed condition, and to 2 interventions — of which Extracorporeal photopheresis (ECP) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05157581 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Georgia, Maryland, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05157581 about?
NCT05157581 is a clinical study titled "Extracorporeal Photopheresis in Sezary Syndrome". 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 asse...
What is the current status of trial NCT05157581?
This trial is currently recruiting. The enrollment target is 20 participants. The study started on 2023-04-04. Estimated completion is 2028-12.
What conditions does trial NCT05157581 study?
This clinical trial studies the following conditions: Sezary Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05157581?
The interventions under investigation include: Extracorporeal photopheresis (ECP) (DEVICE), Methoxsalen Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05157581?
This trial is sponsored by Oleg E. Akilov, MD, PhD, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05157581 being conducted?
This trial has 3 study locations across Georgia, Maryland, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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