Oleg E. Akilov, MD, PhD
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 ).
Cutaneous T-cell lymphoma (CTCL) is a group of skin lymphomas in which malignant lymphocytes infiltrate the skin and, in the later stages, spread to the lymph nodes and blood (leukemia). In the early stages, CTCL generally has a slow course, but in advanced diseases, such as Sezary syndrome (the leukemic form of the disease), there is rapid deterioration. Sezary syndrome is an end-stage variant of CTCL with a mean survival of 1.5 years despite aggressive therapies. Treatment options for the advanced disease are severely limited. In this study, informed consent will be offered to patients who…
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 age…
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 is a light-sensitizing sterile compound added to the collected white blood cells and plasma during ECP.
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