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
Oleg E. Akilov, MD, PhD
20 participants
Apr 4, 2023
OBSERVATIONAL
Conditions
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 ).
Eligibility
Inclusion Criteria5
- 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 Criteria7
- 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. -
Interventions
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.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05157581