Extracorporeal Photopheresis in Sezary Syndrome
ConditionSezary Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorOleg E. Akilov, MD, PhD
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Extracorporeal photopheresis (ECP)
- Methoxsalen Injection
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov