Using extracorporeal photopheresis to treat Sezary Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cutaneous Translational Research Program - Johns Hopkins Medicine
  Baltimore, Maryland, United States Recruiting
• University of Pittsburgh Medical Center
  Pittsburgh, Pennsylvania, United States Recruiting
• Emory University School of Medicine
  Atlanta, Georgia, United States Not yet recruiting

Study contacts

• Principal investigator: Oleg E Akilov, MD, PhD — University of Pittsburgh
• Study coordinator: Charity Ruhl, LPN
• Email: ruhlcl@upmc.edu
• Phone: 4126472013

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.