Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT05680558
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2022-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Photopheresis in Early-stage Mycosis Fungoides
Sponsor:
Columbia University
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
The THERAKOS® CELLEX Photopheresis System is currently FDA approved and indicated for the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) in patients not responsive to other forms of treatment. The original studies in CTCL were performed in patients having extensive patch/plaque or erythrodermic stage disease. Therefore, photopheresis is used primarily to treat stage III or IV CTCL. However, studies have shown that 50% of patients with early disease may have clonal T-cells in their peripheral blood if polymerase chain reaction is used to amplify the T-cell receptor gamma gene fragments. Thus, patients who are staged as T1 or T2 who also have slight abnormalities in blood involvement, such as atypical cells seen on blood smear or abnormal flow cytometry may benefit from photopheresis therapy. This study aims to investigate the efficacy of photopheresis therapy in patients with Stage !A, 1B, or IIA CTCL.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: