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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.

UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis

THERAKOS® CELLEX is an FDA-approved extra-corporeal photopheresis system

THERAKOS® CELLEX photopheresis system

Larisa Geskin, MD

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.

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.

Photopheresis in Early-stage Mycosis Fungoides

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

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.

The time to response calculated from time of photopheresis treatment initiation to the first objective response (clearance of skin disease from baseline ≥50%) observed for participants who achieved a complete response (CR) (clearing of all disease manifestations confirmed by biopsy) or partial response (PR) (partial response defined as \> 50% improvement in the extent of skin involvement).

Duration of response (DOR) will be calculated from time of response to documentation of progression or death.

The FACT-G is a 27-item questionnaire designed to measure four health related quality of life in cancer patients. Scores range from 0-108 with a higher score indicating better quality of life.

The Skindex-29 is a questionnaire with 29 questions that assess the health-related quality of life of patients with skin diseases. Scores range from 0-100 with a higher scoring indicating a worse health status.

The SF-36v2 is a health survey measuring quality of life. Scores range from 0-100 with a higher scoring indicating a better quality of life.

The change in size (single maximum dimension in centimeters) of lymph nodes will be noted as applicable. By definition, the patients should not have pathologically involved lymph nodes.

Change in Sézary cell counts (malignant cells) in blood samples as assessed by flow cytometry. By definition, the enrolled patients will have only minor blood involvement and not leukemia.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Photopheresis in Early-stage Mycosis Fungoides	NCT05680558	Cutaneous T Cel... Mycosis Fungoid...	UVADEX® (methox... THERAKOS® CELLE...	18 Years -	Columbia University
Photopheresis in Early-stage Mycosis Fungoides	NCT05680558	Cutaneous T Cel... Mycosis Fungoid...	UVADEX® (methox... THERAKOS® CELLE...	18 Years -	Columbia University

Spots Global Cancer Trial Database for uvadex® (methoxsalen) sterile solution in conjunction with the therakos® cellex photopheresis