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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis
DrugExtracorporeal Photopheresis (ECP)
THERAKOS® CELLEX photopheresis system
DeviceTHERAKOS® CELLEX is an FDA-approved extra-corporeal photopheresis system
Treatment groups
74 Participants
are divided into 1 treatment groupGroup A: UVA Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis SystemExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
1 YearSecondary outcomes
1
Time to Response of Photopheresis Therapy
The time to response calculated from time of photopheresis treatment initiation to the first objective response (clearance of skin disease from baseline ≥50%) observed for participants who achieved a complete response (CR) (clearing of all disease manifestations confirmed by biopsy) or partial response (PR) (partial response defined as \> 50% improvement in the extent of skin involvement).
Time frame
1 Year2
Duration of Response
Duration of response (DOR) will be calculated from time of response to documentation of progression or death.
Time frame
1 Year3
Change in Functional Assessment of Cancer Therapy - General (FACT-G) Score
The FACT-G is a 27-item questionnaire designed to measure four health related quality of life in cancer patients. Scores range from 0-108 with a higher score indicating better quality of life.
Time frame
Baseline and 1 Year4
Change in Skindex-29 Score
The Skindex-29 is a questionnaire with 29 questions that assess the health-related quality of life of patients with skin diseases. Scores range from 0-100 with a higher scoring indicating a worse health status.
Time frame
Baseline and 1 YearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
Mallinckrodt, Inc.
Collaborator
Source ClinicalTrials.gov