Recruiting
Phase 2

Photopheresis

Sponsor:

Columbia University

Code:

NCT05680558

Conditions

Cutaneous T Cell Lymphoma

Mycosis Fungoides

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

THERAKOS® CELLEX photopheresis system

Study Details

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.

Conditions

Cutaneous T Cell Lymphoma

Mycosis Fungoides

Study ID

NCT05680558

Start date

May 8, 2021

Status verified date

Apr, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

74 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: UVA Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis System

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.

Interventions

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

Extracorporeal Photopheresis (ECP)

THERAKOS® CELLEX photopheresis system

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

Primary outcome measure

  • Overall Response Rate [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

More Information

Sponsor

Columbia University

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Keywords

  • photopheresis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Columbia University on 2026-04-27.