RECRUITING

Extracorporeal Photopheresis in Sezary Syndrome

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary endpoint is to determine if ECP induces a decrease in % of tumor cells after treatment. 15 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 ).

Official Title

Open Label, Single-cohort, and Single-center Phase II Study Evaluating Tumor-specific Immunity After Extracorporeal Photopheresis in Patients With Sézary Syndrome at Single-cell Resolution

Quick Facts

Study Start:2023-04-04
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05157581

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient with an established diagnosis of Sezary syndrome (stage IVA1)
  2. 2. The patient must have a minimum wash-out period of 3 weeks between the last dose of prior systemic therapy
  3. 3. Patients should have recovered from all adverse events related to prior therapy to ≤ grade 1
  4. 4. Signed informed consent form prior to any protocol-specific procedures.
  1. 1. Visceral metastasis of lymphoma
  2. 2. Concomitant administration of radiotherapy or systemic anti-cancer therapy including but not restricted to: chemotherapy, biological agents, or immunotherapy
  3. 3. Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection.
  4. 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. 5. Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.
  6. 6. Patients with known allergy to methoxsalen or heparin -

Contacts and Locations

Study Contact

Charity Ruhl, LPN
CONTACT
4126472013
ruhlcl@upmc.edu
Nicolena Verardi, PA-C
CONTACT
412-864-3682
verardin3@upmc.edu

Principal Investigator

Oleg E Akilov, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Oleg E. Akilov, MD, PhD

  • Oleg E Akilov, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-04
Study Completion Date2026-12

Study Record Updates

Study Start Date2023-04-04
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • extracorporeal photopheresis

Additional Relevant MeSH Terms

  • Sezary Syndrome