Photopheresis in Early-stage Mycosis Fungoides

NCT05680558 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: AAAS9960
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Keywords

photopheresis

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  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.

  1 Year

Secondary Outcomes (7)

• Time to Response of Photopheresis Therapy

  1 Year

• Duration of Response

  1 Year

• Change in Functional Assessment of Cancer Therapy - General (FACT-G) Score

  Baseline and 1 Year

• Change in Skindex-29 Score

  Baseline and 1 Year

• Change in Short Form Survey (SF-36v2) Score

  Baseline and 1 Year

Study Arms (1)

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

EXPERIMENTAL

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.

Drug: UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis; Device: THERAKOS® CELLEX photopheresis system

Interventions

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

Extracorporeal Photopheresis (ECP)

Also known as: UVADEX® with THERAKOS® CELLEX Photopheresis

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

THERAKOS® CELLEX photopheresis system DEVICE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Who are male or female, over the age of 18 and \<40 kg body weight with adequate veins to provide intravenous access.
• Who are willing to adhere to the protocol and sign an Informed Patient Consent Document
• Must not be on any other investigational device/drug treatment.
• 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.
• With IA stage must demonstrate a minor blood abnormality by morphology/laboratory assessment.
• With IIA stage - clinically significant nodes (1.5 cm) must have lymph node biopsy showing dermatopathic nodes or no involvement.
• 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
• 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.
• Must be willing to abstain from therapeutic sunbathing, phototherapy, tanning beds, etc. for the duration of the study.

You may not qualify if:

• Who have MF (T3 cutaneous tumors or T4 exfoliative erythroderma) Stage IIB - IVB
• Who are unable to tolerate extracorporeal volume loss i.e., severe cardiac disease/anemia
• With deterioration of renal function who have a serum creatinine level greater than 3.0 mg/dL.
• 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.
• On oral prednisone therapy or high potency topical steroids.
• Who are pregnant or nursing a child.

Sponsors & Collaborators

• Columbia University: lead
• Mallinckrodt, Inc.: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides

Interventions

Methoxsalen

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Furocoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Larisa Geskin, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Larisa Geskin, MD

CONTACT

212-305-5293; ljg2145@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cutaneous Oncology

Study Record Dates

• First Submitted: November 12, 2022
• First Posted: January 11, 2023
• Study Start: May 8, 2021
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)