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RECRUITING
NCT05680558
PHASE2

Photopheresis in Early-stage Mycosis Fungoides

Sponsor: Columbia University

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether photopheresis therapy can be used to improve the clinical course of early stage cutaneous T-cell lymphoma (CTCL). Currently, photopheresis is performed as a palliative treatment for late stage CTCL. However, recent studies have demonstrated that patients with early stage CTCL may have markers in their blood which were previously observed primarily in late stage disease, such as clonal T cell populations. Considering these findings, the study aims to investigate whether photopheresis therapy may be used earlier in the disease course to produce a clinical response.

Official title: THERAKOS® CELLEX Photopheresis System as an Interventional Therapy for the Treatment of Early Stage CTCL (Mycosis Fungoides), an Open-label, Single-arm, Multi-center, Phase II Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2021-05-08

Completion Date

2027-07

Last Updated

2025-09-23

Healthy Volunteers

No

Interventions

DRUG

UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis

Extracorporeal Photopheresis (ECP)

DEVICE

THERAKOS® CELLEX photopheresis system

THERAKOS® CELLEX is an FDA-approved extra-corporeal photopheresis system

Locations (1)

Herbert Irving Pavilion

New York, New York, United States