Using photopheresis to treat early-stage Mycosis Fungoides

THERAKOS® CELLEX Photopheresis System as an Interventional Therapy for the Treatment of Early Stage CTCL (Mycosis Fungoides), an Open-label, Single-arm, Multi-center, Phase II Study

This study is testing if a light-based treatment called photopheresis can help people with early-stage Mycosis Fungoides, a type of skin lymphoma, feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Columbia University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, methotrexate, prednisone
• Locations: 1 site (New York, New York)
• Trial ID: NCT05680558 on ClinicalTrials.gov

What this trial studies

This study investigates the use of photopheresis therapy to improve outcomes in patients with early-stage cutaneous T-cell lymphoma (CTCL), specifically Mycosis Fungoides. Traditionally, photopheresis has been reserved for late-stage CTCL, but recent findings suggest that early-stage patients may also exhibit markers indicating potential benefit from this treatment. The study will utilize the THERAKOS® CELLEX Photopheresis System in conjunction with UVADEX® to assess its efficacy in patients with specific staging and blood abnormalities. Participants will be closely monitored for clinical responses to the therapy.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with a confirmed diagnosis of Mycosis Fungoides at stages IA, IB, or IIA and specific blood abnormalities.

Not a fit: Patients with advanced-stage Mycosis Fungoides or those currently on other investigational treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with early-stage Mycosis Fungoides, potentially improving their clinical outcomes.

How similar studies have performed: While photopheresis has been effective in late-stage CTCL, this approach in early-stage patients is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Who are male or female, over the age of 18 and \<40 kg body weight with adequate veins to provide intravenous access.
2. Who are willing to adhere to the protocol and sign an Informed Patient Consent Document
3. Must not be on any other investigational device/drug treatment.
4. 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.
5. With IA stage must demonstrate a minor blood abnormality by morphology/laboratory assessment.
6. With IIA stage - clinically significant nodes (1.5 cm) must have lymph node biopsy showing dermatopathic nodes or no involvement.
7. Must be willing and able to discontinue concomitant medications for MF. Subjects currently taking the following drugs must discontinue medication with the following wash out periods prior to enrollment in the trial: PUVA or UVB Therapy - 4 weeks, topical nitrogen mustard or other topical chemotherapy - 4 weeks, bexarotene capsules or other systemic biologic agent - 3 weeks washout, high dose topical steroids, topical retinoids or immunotherapy - 2 week washout with 1% topical hydrocortisone , oral steroids above 10 mg - 30 day washout, unless subject has Addison's Disease or adrenal insufficiency
8. 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 radiation, biological response modifiers or oral methotrexate.
9. Must be willing to abstain from therapeutic sunbathing, phototherapy, tanning beds, etc. for the duration of the study.

Exclusion Criteria:

1. Who have MF (T3 cutaneous tumors or T4 exfoliative erythroderma) Stage IIB - IVB
2. Who are unable to tolerate extracorporeal volume loss i.e., severe cardiac disease/anemia
3. With deterioration of renal function who have a serum creatinine level greater than 3.0 mg/dL.
4. 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.
5. On oral prednisone therapy or high potency topical steroids.
6. Who are pregnant or nursing a child.

Where this trial is running

New York, New York

• Columbia University Irving Medical Center — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Larisa Geskin, MD — Columbia University
• Study coordinator: Larisa Geskin, MD

Conditions Cutaneous T Cell Lymphoma; Mycosis Fungoides; photopheresis