OncoMatch/Clinical Trials/NCT05680558
Photopheresis in Early-stage Mycosis Fungoides
Is NCT05680558 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis and THERAKOS® CELLEX photopheresis system for cutaneous t cell lymphoma.
Treatment: UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis · THERAKOS® CELLEX photopheresis system — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Disease stage
Required: Stage IA, IB, IIA
Excluded: Stage IIB, III, IIIA, IIIB, IV, IVA, IVB
staging as IA, IB or IIA: T1 or T2 (patches or plaques) with measurable lesions. Exclusion: MF (T3 cutaneous tumors or T4 exfoliative erythroderma) Stage IIB - IVB
Prior therapy
Must have received: standard therapy for Stage IA, IB or IIA CTCL (oral steroids, high-dose topical steroids, topical nitrogen mustard, bexarotene, PUVA therapy, electron beam radiation, biological response modifiers, oral methotrexate)
refractory to at least one of the standard therapies used to treat Stage IA, IB or IIA CTCL such as oral steroids, high-dose topical steroids, topical nitrogen mustard, Bexarotene, PUVA therapy, electron beam radiation, biological response modifiers or oral methotrexate
Lab requirements
Kidney function
deterioration of renal function who have a serum creatinine level greater than 3.0 mg/dL
Liver function
history of liver damage (2.5 x normal alanine transaminase (ALT), aspartate aminotransferase (AST))
Cardiac function
unable to tolerate extracorporeal volume loss i.e., severe cardiac disease/anemia
unable to tolerate extracorporeal volume loss i.e., severe cardiac disease/anemia; deterioration of renal function who have a serum creatinine level greater than 3.0 mg/dL; history of liver damage (2.5 x normal alanine transaminase (ALT), aspartate aminotransferase (AST))
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Herbert Irving Pavilion · New York, New York
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