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Photopheresis for Mycosis Fungoides
Phase 2
Recruiting
Led By Larisa Geskin, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Not on any other investigational device/drug treatment
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is studying if photopheresis therapy can help early stage cutaneous T-cell lymphoma (CTCL). It's now used for late stage CTCL, but recent data suggests it could work earlier.
Who is the study for?
Adults over 18, under 40 kg with early-stage cutaneous T-cell lymphoma (CTCL) and minor blood abnormalities. Participants must not be on other investigational treatments, willing to stop certain medications before joining, and able to give informed consent. Excluded are those on high-dose steroids or with severe health issues like kidney failure, uncontrolled diabetes, liver damage, or infectious diseases like HIV.Check my eligibility
What is being tested?
The trial is testing the effectiveness of photopheresis therapy using the THERAKOS® CELLEX system and UVADEX® for improving early-stage CTCL. Photopheresis is usually a palliative treatment for late-stage CTCL but may benefit earlier stages by targeting abnormal blood markers.See study design
What are the potential side effects?
Potential side effects include reactions to methoxsalen such as skin sensitivity to light or sunburn-like effects; discomfort from intravenous access; possible allergic reactions to heparin or citrate used during the procedure; and general risks associated with extracorporeal therapies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not currently participating in any other clinical trials.
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I have been diagnosed with Mycosis Fungoides at an early stage with measurable skin lesions.
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I am willing to stop my current medications for MF with the required washout periods before joining the trial.
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My lymph nodes are enlarged but show no cancer upon biopsy.
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My early-stage cancer shows a slight blood abnormality.
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My skin cancer hasn't responded to at least one standard treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate
Secondary outcome measures
Change in Functional Assessment of Cancer Therapy - General (FACT-G) Score
Change in Short Form Survey (SF-36v2) Score
Change in Size of Lymph Nodes
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: UVA Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis SystemExperimental Treatment2 Interventions
TREATMENT with THERAKOS® CELLEX Photopheresis System on two consecutive days every 2 weeks for the first 3 months; then once per month for following 9 months.
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Who is running the clinical trial?
Mallinckrodt, Inc.UNKNOWN
Columbia UniversityLead Sponsor
1,433 Previous Clinical Trials
2,447,185 Total Patients Enrolled
1 Trials studying Mycosis Fungoides
162 Patients Enrolled for Mycosis Fungoides
Larisa Geskin, MDPrincipal InvestigatorColumbia University
2 Previous Clinical Trials
544 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to stop my current medications for MF with the required washout periods before joining the trial.My kidney function is poor with a creatinine level over 3.0 mg/dL.I am over 18 years old, weigh less than 40 kg, and have veins suitable for IV access.I am currently taking oral prednisone or using strong topical steroids.I am not currently participating in any other clinical trials.I have been diagnosed with Mycosis Fungoides at an early stage with measurable skin lesions.I am willing to avoid sunbathing and using tanning beds during the study.My lymph nodes are enlarged but show no cancer upon biopsy.I do not have severe liver issues, uncontrolled diabetes, lupus, porphyria, HIV, hepatitis B or C, severe mental health issues, or allergies to specific medications.My skin cancer is at an advanced stage, between IIB to IVB.My early-stage cancer shows a slight blood abnormality.I cannot handle blood volume loss due to severe heart disease or anemia.My skin cancer hasn't responded to at least one standard treatment.
Research Study Groups:
This trial has the following groups:- Group 1: UVA Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings available for this experiment?
"Clinicaltrials.gov reveals that this medical experiment is still recruiting patients since its initial posting on May 8, 2021 and most recent amendment on December 23 of the same year."
Answered by AI
What is the magnitude of participants in this investigation?
"Confirmed. Clinicaltrials.gov hosts details of this medical investigation, which was initially published on May 8th 2021 and has been recently updated as of December 23rd 2022. 80 participants are required to be recruited from a single center for the study's completion."
Answered by AI
Could you please delineate any potential hazards associated with the combination of UVA Sterile Solution and UVAR® THERAKOS® CELLEX Photopheresis System?
"With the UVAR® THERAKOS® CELLEX Photopheresis System, UVA Sterile Solution is estimated to be moderately safe by our team at Power due to existing Phase 2 trial data. As of yet there has been no clinical research that confirms efficacy."
Answered by AI
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