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NCT05157581 · ClinicalTrials.gov registry record
Extracorporeal Photopheresis in Sezary Syndrome
A clinical trial of Sezary Syndrome, sponsored by Oleg E. Akilov, MD, PhD.
- Recruiting
- Registry status
- 20
- Enrollment target
- 3
- Study locations
NCT05157581 is a study of Sezary Syndrome that is actively recruiting participants, run by Oleg E. Akilov, MD, PhD. The registered enrollment target is 20 participants, below the 81-participant average among 13 other Sezary Syndrome trials with a reported enrollment target (75% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT05157581, a study of Sezary Syndrome, is actively recruiting participants, sponsored by Oleg E. Akilov, MD, PhD.
- RECRUITING
- Registry status
- 20 participants
- Enrollment target
- 3
- Study locations
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 |
Interested in This Trial?
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, categorized as an unspecified phase. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 81-participant average among 13 other Sezary Syndrome trials with a reported enrollment target (75% lower). The listed sponsor is Oleg E. Akilov, MD, PhD, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT05157581 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Georgia, Maryland, Pennsylvania.
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.
What interventions are being tested in trial NCT05157581?
The interventions under investigation include: Extracorporeal photopheresis (ECP) (DEVICE), Methoxsalen Injection (DRUG).
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.
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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Related
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