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Extracorporeal Photopheresis in Sezary Syndrome

Open Label, Single-cohort, and Multi-center Phase II Study Evaluating Tumor-specific Immunity After Extracorporeal Photopheresis in Patients With Sézary Syndrome at Single-cell Resolution

Who can join

Ages 18 to 100 · All sexes

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. -

About the study

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 ).

What is being tested

• Extracorporeal photopheresis (ECP) (device)
• Methoxsalen Injection (drug)

Sponsor: Oleg E. Akilov, MD, PhD · Participants: 20 · Started: Apr 4, 2023

Contact the study team

• Charity Ruhl, LPN · Phone: 4126472013
• Nicolena Verardi, PA-C · Phone: 412-864-3682

Official record on ClinicalTrials.gov — NCT05157581

Locations in the U.S.

Conditions

• Sezary Syndrome

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.