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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: Recruiting study of Sezary Syndrome, sponsored by Oleg E. Akilov, MD, PhD.
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. According to ClinicalTrials.gov, the official US trial registry.
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 ).
Primary Outcome
Evaluate immune responses post ECP using innovative technology such as single-cell RNA sequencing (scRNAseq) coupled with TCR sequencing to characterize ECP-related change in malignant cells
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 |
What NCT05157581 shows while recruiting
NCT05157581 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 81-participant average among 13 other Sezary Syndrome trials with a reported enrollment target (75% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Sezary Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05157581's enrollment target sits among peer trials
20 10th of 13 higher than 4 of 13 other Sezary Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sezary Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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