NCT05157581 Extracorporeal Photopheresis in Sezary Syndrome
| NCT ID | NCT05157581 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oleg E. Akilov, MD, PhD |
| Condition | Sezary Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-04-04 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2023-04-04 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 agents, or immunotherapy 3. Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection. 4. 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. 5. Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document. 6. Patients with known allergy to Methoxsalen or heparin (as part of SOC ECP procedure). 7. Patients who are pregnant. -
Contact & Investigator
Oleg E Akilov, MD, PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT05157581 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Sezary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05157581 currently recruiting?
Yes, NCT05157581 is actively recruiting participants. Contact the research team at ruhlcl@upmc.edu for enrollment information.
Where is the NCT05157581 trial being conducted?
This trial is being conducted at Atlanta, United States, Baltimore, United States, Pittsburgh, United States.
Who is sponsoring the NCT05157581 clinical trial?
NCT05157581 is sponsored by Oleg E. Akilov, MD, PhD. The principal investigator is Oleg E Akilov, MD, PhD at University of Pittsburgh. The trial plans to enroll 20 participants.