Extracorporeal Photopheresis in Sezary Syndrome
Recruiting
Observational Study
Sezary Syndrome
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 – 100
- Sex
- Any
- Study type
- Observational
- Participants needed
- 20 (estimated)
- Sponsor
- Oleg E. Akilov, MD, PhD · Other
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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 …
Trial Locations
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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 t…
Contacts