Extracorporeal Photopheresis in Sezary Syndrome

NCT05157581 | Recruiting DMC FDA Drug FDA Device

• 1 other identifier: STUDY21100115
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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

Sezary Syndrome

Keywords

extracorporeal photopheresis

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• 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

Other Outcomes (3)

• 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

Study Arms (1)

Sezary Syndrome

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

Device: Extracorporeal photopheresis (ECP); Drug: Methoxsalen Injection

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.

Also known as: ECP, photopheresis

Sezary Syndrome

Methoxsalen Injection DRUG

Methoxsalen is a light-sensitizing sterile compound added to the collected white blood cells and plasma during ECP.

Also known as: Uvadex

Sezary Syndrome

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Sezary syndrome

You may qualify if:

• Patient with an established diagnosis of Sezary syndrome (stage IVA1)
• Patients amenable for ECP
• The patient must have a minimum wash-out period of 3 weeks between the last dose of prior systemic therapy
• Patients should have recovered from all adverse events related to prior therapy to ≤ grade 1
• Signed informed consent form prior to any protocol-specific procedures.

You may not qualify if:

• Visceral metastasis of lymphoma
• Concomitant administration of radiotherapy or systemic anti-cancer therapy including but not restricted to: chemotherapy, biological agents, or immunotherapy
• Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection.
• Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol.
• Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.
• Patients with known allergy to Methoxsalen or heparin (as part of SOC ECP procedure).
• Patients who are pregnant. -

Sponsors & Collaborators

• Oleg E. Akilov, MD, PhD: lead
• Therakos: collaborator

Study Sites (3)

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

Cutaneous Translational Research Program - Johns Hopkins Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 31139332 BACKGROUND

• 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.

  PMID: 26433848 BACKGROUND

• 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.

  PMID: 24600032 BACKGROUND

• 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.

  PMID: 32597303 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

Sezary Syndrome

Interventions

Photopheresis; Methoxsalen

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

PUVA Therapy; Ultraviolet Therapy; Phototherapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative; Furocoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Oleg E Akilov, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charity Ruhl, LPN

CONTACT

4126472013; ruhlcl@upmc.edu

Nicolena Verardi, PA-C

CONTACT

412-864-3682; verardin3@upmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 15, 2021
• Study Start: April 4, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)