Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous T Cell Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Mycosis Fungoides | Mycosis Fungoides | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| THERAKOS® CELLEX photopheresis system | Device | — | UNRESOLVED |
| UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- UVA Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis System
- description
- 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.
- interventionNames
- Drug: UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis
- Device: THERAKOS® CELLEX photopheresis system
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- 1 Year
- description
- 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.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Who are male or female, over the age of 18 and \<40 kg body weight with adequate veins to provide intravenous access. 2. Who are willing to adhere to the protocol and sign an Informed Patient Consent Document 3. Must not be on any other investigational device/drug treatment. 4. Who have the diagnosis of Mycosis Fungoides (MF) including a skin biopsy consistent with MF (atypical epidermotropic or folliculocentric T-cells) with appropriate staging as IA, IB or IIA: T1 or T2 (patches or plaques) with measurable lesions. 5. With IA stage must demonstrate a minor blood abnormality by morphology/laboratory assessment. 6. With IIA stage - clinically significant nodes (1.5 cm) must have lymph node biopsy showing dermatopathic nodes or no involvement. 7. Must be willing and able to discontinue concomitant medications for MF. Subjects currently taking the following drugs must discontinue medication with the following wash out periods prior to enrollment in the trial: PUVA or UVB Therapy - 4 weeks, topical nitrogen mustard or other topical chemotherapy - 4 weeks, bexarotene capsules or other systemic biologic agent - 3 weeks washout, high dose topical steroids, topical retinoids or immunotherapy - 2 week washout with 1% topical hydrocortisone , oral steroids above 10 mg - 30 day washout, unless subject has Addison's Disease or adrenal insufficiency 8. Who are 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. 9. Must be willing to abstain from therapeutic sunbathing, phototherapy, tanning beds, etc. for the duration of the study. Exclusion Criteria: 1. Who have MF (T3 cutaneous tumors or T4 exfoliative erythroderma) Stage IIB - IVB 2. Who are unable to tolerate extracorporeal volume loss i.e., severe cardiac disease/anemia 3. With deterioration of renal function who have a serum creatinine level greater than 3.0 mg/dL. 4. With lipemic plasma \>500 ng/dL, uncontrolled diabetes, history of liver damage (2.5 x normal alanine transaminase (ALT), aspartate aminotransferase (AST), porphyria, lupus, positive tests for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody or Hepatitis B Surface Antigen, severe emotional, behavioral or psychiatric problems that, in the opinion of the investigator, would result in poor compliance with the treatment regimen, and idiosyncratic or hypersensitivity reactions to 8-methoxypsoralen compounds, heparin, or citrate. 5. On oral prednisone therapy or high potency topical steroids. 6. Who are pregnant or nursing a child.
References
Publications (0)
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