Recruiting

Extracorporeal Photopheresis

Sponsor:

Oleg E. Akilov, MD, PhD

Code:

NCT05157581

Conditions

Sezary Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Extracorporeal photopheresis (ECP)

Methoxsalen Injection

Study Details

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

Study ID

NCT05157581

Start date

Apr 4, 2023

Status verified date

Dec, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. Visceral metastasis of lymphoma
2. Concomitant administration of radiotherapy or systemic anti-cancer therapy including but not restricted to: chemotherapy, biological agents, or immunotherapy
3. Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection.
4. 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.
5. Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.
6. Patients with known allergy to Methoxsalen or heparin (as part of SOC ECP procedure).
7. Patients who are pregnant. -

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Sezary Syndrome

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

Interventions

Extracorporeal photopheresis (ECP)

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

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

Primary outcome measure

  • Change from baseline in tumor-specific immunity [ Time Frame: Up to 3 months post baseline ]
  • Change from baseline in tumor-specific immunity [ Time Frame: Up to 6 months post baseline ]

Central Contacts and Locations

Central contacts

Nicolena Verardi, PA-C

412-864-3682verardin3@upmc.edu

Locations

Cutaneous Translational Research Program - Johns Hopkins Medicine

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Principal Investigator:

Sima Rozati, MD, PhD

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Principal Investigator:

Oleg E Akilov, MD, PhD

More Information

Sponsor

Oleg E. Akilov, MD, PhD

Last update posted

Dec 30, 2025

Last verified

Dec, 2025

Keywords

  • extracorporeal photopheresis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Oleg E. Akilov, MD, PhD on 2025-12-30.