Extracorporeal Photopheresis in Sezary Syndrome

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Oleg E. Akilov, MD, PhD
Study ID
NCT05157581
Status
Recruiting
Apply to this trial

Conditions

  • Sezary Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Extracorporeal photopheresis (ECP) — DEVICE
    Extracorporeal photopheresis is a process that exposes a collection of white blood cells and plasma to a light sensitizing agent, methoxsalen, and returns that compartment to the body.
  • Methoxsalen Injection — DRUG
    Methoxsalen is a light-sensitizing sterile compound added to the collected white blood cells and plasma during ECP.

Study Details

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 ).

Key Dates

Start date
Apr 4, 2023
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Sezary Syndrome
    20 subjects with Sezary Syndrome will comprise the single arm of this study

Primary Outcome Measure

Change from baseline in tumor-specific immunity [ Time Frame: Up to 3 months post baseline ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Emory University School of MedicineAtlantaGeorgia30322
Pamela B Allen, MD, MSc
[email protected]
404-778-6195
Pamela B Allen, MD, MSc (PRINCIPAL_INVESTIGATOR)
Cutaneous Translational Research Program - Johns Hopkins MedicineBaltimoreMaryland21287
Toan Bui, BS
[email protected]
443-856-7329
Sima Rozati, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
Charity Ruhl, LPN
[email protected]
412-647-2013
Nicolena Verardi, PA-C
[email protected]
412-864-3682
Oleg E Akilov, MD, PhD (PRINCIPAL_INVESTIGATOR)

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Emory University School of Medicine· Atlanta, GACutaneous Translational Research Program - Johns Hopkins Medicine· Baltimore, MDUniversity of Pittsburgh Medical Center· Pittsburgh, PA

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