Actively Recruiting
Led by Oleg E. Akilov, MD, PhD · Updated on 2025-12-30
20
Participants Needed
3
Research Sites
N/A
Total Duration
O
Oleg E. Akilov, MD, PhD
Lead Sponsor
T
Therakos
Collaborating Sponsor
Researchers are evaluating how extracorporeal photopheresis (ECP) affects tumor cells and immune responses in patients with Sezary Syndrome, a severe form of cutaneous T-cell lymphoma that rapidly worsens and has limited treatment options. This study aims to understand changes in the tumor environment and immune system after ECP, using advanced techniques like single-cell RNA sequencing to analyze blood samples and correlate findings with clinical outcomes. The study is led by Oleg E. Akilov, MD, PhD, and focuses on improving knowledge about immune responses in this condition. Participants will receive ECP treatment once a week for four weeks and then every two weeks for five months. ECP involves collecting white blood cells and plasma, exposing them to a light-sensitizing drug called methoxsalen, and returning them to the body. During the study, patients will provide blood samples at five time points to assess immune changes, and clinical assessments will include skin tumor burden measurement, flow cytometry of blood, and CT scans at baseline and as needed. Throughout the trial, researchers will monitor tumor-specific immunity and objective treatment responses up to six months after starting ECP. Assessments include skin weighted evaluation, blood tests, and imaging to detect disease progression. Participants will be observed closely, with blood and tissue samples collected to study molecular changes. The total study duration covers initial treatment and follow-up, with safety and disease status tracked regularly.
CONDITIONS
Extracorporeal Photopheresis in Sezary Syndrome
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants undergo extracorporeal photopheresis (ECP) treatment involving exposure of white blood cells and plasma to a light sensitizing agent.
Twice weekly visits for 4 weeks, then twice monthly visits for 5 months
Duration - 6 months
Blood samples are collected to assess immune responses and tumor burden at specified points during and after treatment.
5 blood draws: at baseline, day after first ECP, and at months 1, 3, and 6
Duration - 6 months
Standard assessments including skin tumor burden measurement, blood tumor burden, and CT scans are performed to evaluate disease status.
Baseline assessment and follow-up assessments at months 3 and 6 if lymph node or organ involvement was identified at baseline
Total: 3 locations
1
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
2
Cutaneous Translational Research Program - Johns Hopkins Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
3
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
C
Charity Ruhl, LPN
N
Nicolena Verardi, PA-C
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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