RecruitingPhase 2NCT05680558

Photopheresis in Early-stage Mycosis Fungoides

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

Sponsor

Columbia University

Enrollment

74 participants

Start Date

May 8, 2021

Study Type

INTERVENTIONAL

Conditions

Mycosis Fungoides Cutaneous T Cell Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a blood-based treatment called extracorporeal photopheresis (ECP) — where a patient's blood is drawn out, treated with a light-activated drug and UV light, then returned — for early-stage mycosis fungoides, a type of slow-growing skin lymphoma (cancer of the skin's immune cells). **You may be eligible if...** - You are over 18 years old - You have been diagnosed with early-stage mycosis fungoides (Stage IA, IB, or IIA) confirmed by skin biopsy - Your skin cancer has not responded adequately to at least one standard therapy - You have accessible veins and weigh under 40 kg (this criterion may reflect a specific dosing consideration) - You are willing to stop any other active skin cancer treatments before starting **You may NOT be eligible if...** - Your mycosis fungoides is more advanced (Stage IIB–IVB, including tumors or full-body redness) - You have severe heart disease, anemia that prevents you from tolerating the procedure, or significant kidney or liver problems - You are HIV positive, or have hepatitis B or C - You are pregnant or breastfeeding - You are on oral steroids or high-potency topical steroids Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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