Photopheresis in Early-stage Mycosis Fungoides

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT05680558
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cutaneous T Cell Lymphoma
  • Mycosis Fungoides

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis — DRUG
    Extracorporeal Photopheresis (ECP)
  • THERAKOS® CELLEX photopheresis system — DEVICE
    THERAKOS® CELLEX is an FDA-approved extra-corporeal photopheresis system

Study Details

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.

Key Dates

Start date
May 8, 2021
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
74 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: UVA Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis System
    TREATMENT with THERAKOS® CELLEX Photopheresis System on two consecutive days every 2 weeks for the first 3 months; then once per month for following 9 months.

Primary Outcome Measure

Overall Response Rate [ Time Frame: 1 Year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Larisa Geskin, MD
[email protected]
212-305-5293

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By research site
Columbia University Irving Medical Center· New York, NY

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