BridgeMD
New treatment option for Cutaneous T Cell Lymphoma
Official title Photopheresis in Early-stage Mycosis Fungoides
ClinicalTrials.gov ID: NCT05680558
What this study is testing
What is UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis?
UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cutaneous t cell lymphoma.
Also referred to as UVADEX® with THERAKOS® CELLEX Photopheresis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 IA stage must demonstrate a minor blood abnormality by morphology/laboratory assessment.
You likely can't join 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...
- On oral prednisone therapy or high potency topical steroids.
- Who are pregnant or nursing a child.
See the full eligibility criteria
- 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 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. people currently taking the following drugs must discontinue medication with the following wash out periods prior to enrollment in the trial: PUVA...
- 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...
- Must be willing to abstain from therapeutic sunbathing, phototherapy, tanning beds, etc. for the duration of the study.
- 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...
- On oral prednisone therapy or high potency topical steroids.
- Who are pregnant or nursing a child.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.