Photopheresis in Early-stage Mycosis Fungoides
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis
- THERAKOS® CELLEX photopheresis system
Treatment groups
74 Participants
are divided into 1 treatment groupSponsors and collaborators
Columbia University
Lead sponsor
Mallinckrodt, Inc.
Collaborator
Source ClinicalTrials.gov