Actively Recruiting
Photopheresis in Early-stage Mycosis Fungoides
Led by Columbia University · Updated on 2026-04-27
74
Participants Needed
1
Research Sites
373 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
M
Mallinckrodt, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Photopheresis in Early-stage Mycosis Fungoides
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female over age 18 and weighing less than 40 kg with veins suitable for intravenous access
- Willing to follow the study protocol and sign informed consent
- Not currently receiving other investigational treatments
- Diagnosed with Mycosis Fungoides stage IA, IB, or IIA confirmed by skin biopsy and staging
- Stage IA patients must show minor blood abnormalities by lab assessment
- Stage IIA patients with significant lymph nodes must have biopsy showing dermatopathic nodes or no involvement
- Able and willing to stop other Mycosis Fungoides medications with required washout periods before enrollment
- Refractory to at least one standard therapy for stage IA, IB, or IIA CTCL (e.g., steroids, topical chemotherapy, radiation)
- Willing to avoid therapeutic sun exposure and phototherapy during the study
You will not qualify if you...
- Patients with advanced Mycosis Fungoides stages IIB to IVB (T3 tumors or T4 erythroderma)
- Unable to tolerate extracorporeal volume loss due to severe heart disease or anemia
- Significant kidney dysfunction with serum creatinine over 3.0 mg/dL
- Lipemic plasma above 500 ng/dL, uncontrolled diabetes, liver damage, porphyria, lupus, positive HIV or hepatitis tests
- Severe psychiatric or behavioral issues affecting treatment compliance
- Allergic reactions to study medications or components like 8-methoxypsoralen, heparin, or citrate
- Currently on oral prednisone or high potency topical steroids
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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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
CONTACT
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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