Extracorporeal Photopheresis in Sezary Syndrome

Launched by OLEG E. AKILOV, MD, PHD · Dec 1, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Extracorporeal Photopheresis (ECP) for patients with Sezary Syndrome, a type of skin lymphoma. The goal is to see if ECP can reduce the number of cancer cells in the blood after treatment. In this trial, 15 patients will receive ECP once a week for four weeks and then every other week for five months. Throughout the study, participants will provide blood samples to help researchers understand how their immune system responds to the treatment. Additionally, doctors will assess skin conditions and take CT scans to monitor any changes.

To participate in this trial, patients must have a confirmed diagnosis of Sezary Syndrome and should have taken a break from any previous cancer treatments for at least three weeks. They should also be in good health overall and able to understand the study details. During the trial, participants can expect regular treatments and follow-ups to track their progress and gather important information about how ECP works. This study is currently recruiting patients, and it offers a chance to contribute to research aimed at improving treatment for this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient with an established diagnosis of Sezary syndrome (stage IVA1)
• • 2. The patient must have a minimum wash-out period of 3 weeks between the last dose of prior systemic therapy
• • 3. Patients should have recovered from all adverse events related to prior therapy to ≤ grade 1
• • 4. 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 -