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Photopheresis in Early-stage Mycosis Fungoides

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Mar 2026 to Mar 2027 Completion date: Jul 2027 to Jul 2028 · Study site revisedv5 Show 2 more changesShow less
    • Completion date: Jul 2027 to Jul 2028
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Dec 14, 2025 to Mar 2026 Completion date: Jul 25, 2026 to Jul 2027v4 Show 1 more changeShow less
    • Completion date: Jul 25, 2026 to Jul 2027
  3. Re-verified, no change to tracked fieldsv3
  4. Enrollment target: 80 to 74 Primary completion date: Dec 2025 to Dec 14, 2025 · Completion date: Jul 2026 to Jul 25, 2026 · Interventions: THERAKOS® CELLEX photopheresis system (Device), UVADEX® (methoxsalen) Sterile Solution in conjunction with the UVAR® THERAKOS® CELLEX… to THERAKOS® CELLEX photopheresis system (Device), UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX… · 2 morev2 Show 5 more changesShow less
    • Primary completion date: Dec 2025 to Dec 14, 2025
    • Completion date: Jul 2026 to Jul 25, 2026
    • Interventions: THERAKOS® CELLEX photopheresis system (Device), UVADEX® (methoxsalen) Sterile Solution in conjunction with the UVAR® THERAKOS® CELLEX… to THERAKOS® CELLEX photopheresis system (Device), UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX…
    • Study description shortened, about 1 word
    • Collaborators expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05680558
Lead Sponsor Columbia University
Collaborators: Mallinckrodt, Inc.
Conditions Cutaneous T Cell Lymphoma, Mycosis Fungoides
Enrollment 74 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov