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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

Must not have

Deterioration of renal function with a serum creatinine level greater than 3.0 mg/dL

On oral prednisone therapy or high potency topical steroids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is poor with a creatinine level over 3.0 mg/dL.

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I am currently taking oral prednisone or using strong topical steroids.

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My skin cancer is at an advanced stage, between IIB to IVB.

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I cannot handle blood volume loss due to severe heart disease or anemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 10Eligibility criteria met