Extracorporeal Photopheresis in Sezary Syndrome
About this study
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 ).
- Condition
- Sezary Syndrome
- Tested
- Extracorporeal photopheresis (ECP), Methoxsalen Injection
- Sponsor
- Oleg E. Akilov, MD, PhD
Who can join
- Age
- 18 to 100 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Maximum age: 100 years
- Study condition: Sezary Syndrome
- 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 7
- 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. -
Where
3 sites, 3 recruiting
Cutaneous Translational Research Program - Johns Hopkins Medicine
Baltimore, Maryland, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Contact
-
Charity Ruhl, LPN
4126472013 ruhlcl@upmc.edu
-
Nicolena Verardi, PA-C
412-864-3682 verardin3@upmc.edu
Potential match only. Final eligibility is determined by the study team.