Extracorporeal Photopheresis in Sezary Syndrome

Recruiting now

Conditions studied: Sezary Syndrome

In brief

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 facts

Study ID

NCT05157581

Run by

Oleg E. Akilov, MD, PhD

People needed

20

Starts

2023-04-04

Expected to finish

2028-12-01

Last updated by the study team

2025-12-30

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

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. -

Where it is running

• Cutaneous Translational Research Program - Johns Hopkins Medicine — Baltimore, Maryland, United States (enrolling)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Emory University School of Medicine — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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