Sponsor study identifier
observational
20
1 country
3
Study Start
April 4, 2023
Actual (reported)Primary Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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 ).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 16, 2021
Actual (reported)December 15, 2021
Actual (reported)April 4, 2023
Actual (reported)December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change from baseline in tumor-specific immunity
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
Up to 3 months post baseline
Change from baseline in tumor-specific immunity
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
Up to 6 months post baseline
Change from baseline in the objective response rate for ECP therapy
Up to 3 months post baseline
Change from baseline in the objective response rate for ECP therapy
Up to 6 months post baseline
Change from baseline in the objective response rate by disease compartment
Up to 3 months post baseline
Change from baseline in the objective response rate by disease compartment
Up to 6 months post baseline
Correlation of clinical responses and changes in tumor microenvironment in the blood.
Up to 6 months post baseline
20 subjects with Sezary Syndrome will comprise the single arm of this study
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 is a light-sensitizing sterile compound added to the collected white blood cells and plasma during ECP.
Patients with Sezary syndrome
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Cutaneous Translational Research Program - Johns Hopkins Medicine
Baltimore, Maryland, 21287, United States
Ying Z, Shiue L, Park K, Kollet J, Bijani P, Goswami M, Duvic M, Ni X. Blood transcriptional profiling reveals IL-1 and integrin signaling pathways associated with clinical response to extracorporeal photopheresis in patients with leukemic cutaneous T-cell lymphoma. Oncotarget. 2019 May 7;10(34):3183-3197. doi: 10.18632/oncotarget.26900. eCollection 2019 May 7.
Zic JA. Extracorporeal Photopheresis in the Treatment of Mycosis Fungoides and Sezary Syndrome. Dermatol Clin. 2015 Oct;33(4):765-76. doi: 10.1016/j.det.2015.05.011. Epub 2015 Jul 29.
Peripheral blood
Oleg E Akilov, MD, PhD
University of Pittsburgh
First Submitted
November 16, 2021
First Posted
December 15, 2021
Study Start
April 4, 2023
Actual (reported)Primary Completion
December 2028
EstimatedContact the study team to confirm eligibility.
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Spary LK, Al-Taei S, Salimu J, Cook AD, Ager A, Watson HA, Clayton A, Staffurth J, Mason MD, Tabi Z. Enhancement of T cell responses as a result of synergy between lower doses of radiation and T cell stimulation. J Immunol. 2014 Apr 1;192(7):3101-10. doi: 10.4049/jimmunol.1302736. Epub 2014 Mar 5.
Curion F, Handel AE, Attar M, Gallone G, Bowden R, Cader MZ, Clark MB. Targeted RNA sequencing enhances gene expression profiling of ultra-low input samples. RNA Biol. 2020 Dec;17(12):1741-1753. doi: 10.1080/15476286.2020.1777768. Epub 2020 Jun 28.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 30, 2025
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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