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NCT05680558 · ClinicalTrials.gov registry record · Phase 2
Photopheresis in Early-stage Mycosis Fungoides
A Phase 2 study of Cutaneous T Cell Lymphoma and Mycosis Fungoides, sponsored by Columbia University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 74
- Enrollment target
- 1
- Study location
NCT05680558: Recruiting Phase 2 study of Cutaneous T Cell Lymphoma and Mycosis Fungoides, sponsored by Columbia University.
NCT05680558 is a Phase 2 study of Cutaneous T Cell Lymphoma and Mycosis Fungoides that is actively recruiting participants, run by Columbia University. The registered enrollment target is 74 participants, above the 64-participant average among 23 other Cutaneous T Cell Lymphoma trials with a reported enrollment target (16% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05680558, a Phase 2 study of Cutaneous T Cell Lymphoma and Mycosis Fungoides, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 74 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Overall response rate at 1 year measured by the modified skin-weighted assessment tool (mSWAT) in accordance with Olsen et al criteria for response in clinical trial. Measurable lesions are defined as those that can be accurately measured in at least one dimension.
Conditions Studied
Interventions
- DRUG UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis
- DEVICE THERAKOS® CELLEX photopheresis system
Study Locations (1)
New York
- Herbert Irving Pavilion - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2021-05-08 |
| Est. Completion | 2027-07 |
| Phase | Phase 2 |
What NCT05680558 shows while recruiting
NCT05680558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 64-participant average among 23 other Cutaneous T Cell Lymphoma trials with a reported enrollment target (16% higher).
The record links to 2 conditions, with Cutaneous T Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis is the first listed.
NCT05680558 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05680558 about?
NCT05680558 is a clinical study titled "Photopheresis in Early-stage Mycosis Fungoides". 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 pati...
What is the current status of trial NCT05680558?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2021-05-08. Estimated completion is 2027-07.
What conditions does trial NCT05680558 study?
This clinical trial studies the following conditions: Cutaneous T Cell Lymphoma, Mycosis Fungoides.
What interventions are being tested in trial NCT05680558?
The interventions under investigation include: UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis (DRUG), THERAKOS® CELLEX photopheresis system (DEVICE).
Who is sponsoring clinical trial NCT05680558?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05680558 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cutaneous T Cell Lymphoma
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Where NCT05680558's enrollment target sits among peer trials
74 7th of 23 higher than 17 of 23 other Cutaneous T Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cutaneous T Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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