Extracorporeal Photopheresis in Sezary Syndrome (NCT05157581) | Clinical Trial Compass
RecruitingNot Applicable
Extracorporeal Photopheresis in Sezary Syndrome
United States20 participantsStarted 2023-04-04
Plain-language 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 ).
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.