Actively Recruiting
THERAKOS4 CELLEX Photopheresis System for Early Stage Cutaneous T-Cell Lymphoma (Mycosis Fungoides) Treatment, Open-label, Single-arm, Multi-center, Phase II Study
Led by Columbia University · Updated on 2026-04-27
74
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
M
Mallinckrodt, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether photopheresis therapy can improve the clinical course of early stage cutaneous T-cell lymphoma (CTCL), specifically in patients with Mycosis Fungoides. This study focuses on stages IA, IB, or IIA CTCL, where some patients may have blood markers previously seen only in later stages. The goal is to investigate if using photopheresis earlier can produce a clinical response, expanding its current use beyond late-stage disease. Participants will receive treatment using the THERAKOS4 CELLEX Photopheresis System combined with UVADEX4 (methoxsalen) sterile solution. Treatment is given on two consecutive days every two weeks for the first three months, followed by once per month for nine months. This open-label, single-arm study assesses photopheresis therapy as an interventional treatment in early stage CTCL. During the study, participants will be monitored over one year with assessments including response to treatment, time to response, and duration of response. Patient-reported outcomes like the Functional Assessment of Cancer Therapy - General (FACT-G), Skindex-29, and Short Form Survey (SF-36v2) will be measured at baseline and one year. Researchers will also track changes in lymph node size and Sézary cell counts at baseline, six months, and twelve months to evaluate safety and effectiveness.
CONDITIONS
Brief Title
Photopheresis in Early-stage Mycosis Fungoides
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female over 18 years old and weighing less than 40 kg with veins suitable for intravenous access
- Willing to follow the study protocol and sign informed consent
- Not currently on any other investigational drug or device
- Diagnosed with Mycosis Fungoides (MF) stages IA, IB, or IIA with measurable lesions confirmed by skin biopsy
- Stage IA patients must show minor blood abnormalities by lab tests
- Stage IIA patients with lymph nodes 1.5 cm must have biopsy showing dermatopathic nodes or no involvement
- Able and willing to stop certain medications for MF with specified washout periods before enrollment
- Refractory to at least one standard therapy used for stage IA, IB, or IIA CTCL
- Willing to avoid sunbathing, phototherapy, tanning beds during the study
You will not qualify if you...
- Diagnosed with advanced MF stages IIB to IVB (T3 tumors or T4 erythroderma)
- Unable to tolerate blood volume loss due to severe heart disease or anemia
- Kidney function deterioration with serum creatinine over 3.0 mg/dL
- Lipemic plasma over 500 ng/dL, uncontrolled diabetes, liver damage above specified levels, porphyria, lupus, positive HIV, hepatitis C or B infection
- Severe emotional, behavioral, or psychiatric problems affecting treatment compliance
- Allergic reactions to 8-methoxypsoralen compounds, heparin, or citrate
- Taking oral prednisone or high potency topical steroids
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants receive photopheresis therapy using the THERAKOS® CELLEX Photopheresis System with UVADEX® (methoxsalen) on two consecutive days every 2 weeks for the first 3 months, then once per month for the following 9 months.
Treatment visits on two consecutive days every 2 weeks for 3 months, then monthly visits for 9 months
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
L
Larisa Geskin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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