Using extracorporeal photopheresis to treat 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

This study is testing if a treatment called extracorporeal photopheresis can help people with Sezary Syndrome improve their skin condition and overall health.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: University of Pittsburgh (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 3 sites (Atlanta, Georgia and 2 other locations)
• Trial ID: NCT05157581 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of extracorporeal photopheresis (ECP) in patients diagnosed with Sezary Syndrome, a severe form of cutaneous T-cell lymphoma. Fifteen participants will undergo ECP treatments weekly for four weeks, followed by bi-weekly sessions for five months. Blood samples will be collected at various intervals to assess immune responses and changes in the tumor microenvironment. Clinical assessments will include skin tumor burden measurements and CT scans to monitor disease progression.

Who should consider this trial

Good fit: Ideal candidates are patients with an established diagnosis of Sezary Syndrome who have completed prior therapies and meet specific health criteria.

Not a fit: Patients with visceral metastasis of lymphoma or those currently receiving other systemic therapies will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients with limited therapies available for advanced Sezary Syndrome.

How similar studies have performed: While ECP has been used in other contexts, this specific application in Sezary Syndrome is novel and has not been extensively tested in prior studies.

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. -

Where this trial is running

Atlanta, Georgia and 2 other locations

• Emory University School of Medicine — Atlanta, Georgia, United States (Not_yet_recruiting)
• Cutaneous Translational Research Program - Johns Hopkins Medicine — Baltimore, Maryland, United States (Recruiting)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Oleg E Akilov, MD, PhD — University of Pittsburgh
• Study coordinator: Charity Ruhl, LPN

Conditions Sezary Syndrome; extracorporeal photopheresis