Photopheresis for Mycosis Fungoides

Overseen by Larisa J Geskin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Columbia University

Must not be taking: Oral prednisone, High potency steroids

Disqualifiers: Severe cardiac disease, Uncontrolled diabetes, HIV, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of 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.

Do I need to stop my current medications for the trial?

Yes, you will need to stop taking certain medications for Mycosis Fungoides before joining the trial. There are specific 'washout' periods (time without taking certain medications) required: 4 weeks for PUVA or UVB therapy and topical chemotherapy, 3 weeks for bexarotene capsules, 2 weeks for high dose topical steroids, and 30 days for oral steroids above 10 mg, unless you have Addison's Disease or adrenal insufficiency.

What data supports the effectiveness of the treatment THERAKOS® CELLEX photopheresis system for mycosis fungoides?

Extracorporeal photopheresis (ECP) is considered an effective treatment for mycosis fungoides, with studies indicating it has few systemic side effects. Additionally, ECP is recommended for use in combination with other therapies for certain forms of the disease, suggesting its beneficial role in treatment plans. ^{1 2 3 4 5}

Is extracorporeal photopheresis (ECP) safe for humans?

Extracorporeal photopheresis (ECP) is generally considered safe, with few systemic side effects reported. In a study involving children and young adults, the Therakos™ Cellex® system showed good safety and tolerability, with some minor issues like central venous line problems and infections, but no serious adverse effects like symptomatic low blood pressure. ^{1 2 3 5 6}

How is the THERAKOS CELLEX photopheresis system treatment different from other treatments for mycosis fungoides?

The THERAKOS CELLEX photopheresis system is unique because it uses a fully integrated, continuous flow system that reduces treatment times and blood volumes needed, making it more efficient compared to older systems. It also offers flexibility with single- or dual-needle configurations, which can be more comfortable for patients. ^{1 3 4 5 7}

Research Team

Larisa J Geskin, MD

Principal Investigator

Columbia University

Eligibility Criteria

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.

Inclusion Criteria

I am willing to stop my current medications for MF with the required washout periods before joining the trial.

Willing to adhere to the protocol and sign an Informed Patient Consent Document

I am over 18 years old, weigh less than 40 kg, and have veins suitable for IV access.

Exclusion Criteria

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

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

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.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive photopheresis treatment with the THERAKOS® CELLEX Photopheresis System on two consecutive days every 2 weeks for the first 3 months; then once per month for the following 9 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• THERAKOS® CELLEX photopheresis system (Procedure)
• UVADEX® (methoxsalen) Sterile Solution (Photosensitizer)

Trial Overview 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.

Participant Groups

Group I: UVA Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis System Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Mallinckrodt, Inc.

Collaborator

Trials

1

Recruited

70+

Findings from Research

Extracorporeal photopheresis (ECP) combined with other therapies resulted in a 65% overall response rate in 20 patients with erythrodermic mycosis fungoides and Sezary syndrome, with 30% achieving complete response and 35% partial response, lasting over 2 years for 38.5% of patients.

In patients with leukaemic involvement, the blood response to ECP occurred earlier and was maintained longer than the skin response, indicating that a positive blood response does not necessarily predict improvement in skin symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erythrodermic mycosis fungoides and Sézary syndrome treated with extracorporeal photopheresis as part of a multimodality regimen: A single-centre experience. Atzmony, L., Amitay-Laish, I., Gurion, R., et al.[2016]

Extracorporeal photopheresis (ECP) using the Therakos™ Cellex(®) device is a safe and tolerable second-line treatment for graft-versus-host disease (GVHD) in children and young adults, with a review of 385 procedures showing low rates of complications.

The study found that using prophylactic tissue plasminogen activator reduced central venous line-related occlusions, highlighting a strategy to improve the safety of ECP procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of novel Therakos™ Cellex® for extracorporeal photopheresis in treatment of graft-versus-host disease in paediatric patients. Rangarajan, HG., Punzalan, RC., Camitta, BM., et al.[2019]

Extracorporeal photo-chemotherapy (ECP) showed an overall response rate of 42% in 50 patients with mycosis fungoides, with a median time to response of 11 months, indicating its efficacy as a treatment option.

ECP was associated with a low incidence of adverse events (16%) and significantly improved overall survival when combined with other therapies, suggesting it is a safe and effective treatment for mycosis fungoides.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extracorporeal photochemotherapy in mycosis fungoides. Atilla, E., Atilla, PA., Bozdag, SC., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

A transition from using multi-step procedures to a fully integrated system for performing extracorporeal photopheresis: A comparison of costs and efficiencies. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Long-term application of extracorporeal photochemotherapy in severe atopic dermatitis. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Racial differences in the use of extracorporeal photopheresis for mycosis fungoides. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Erythrodermic mycosis fungoides and Sézary syndrome treated with extracorporeal photopheresis as part of a multimodality regimen: A single-centre experience. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Safety of a new, single, integrated, closed photopheresis system in patients with cutaneous T-cell lymphoma. [2013]

6. England pubmed.ncbi.nlm.nih.gov

The use of novel Therakos™ Cellex® for extracorporeal photopheresis in treatment of graft-versus-host disease in paediatric patients. [2019]

7. France pubmed.ncbi.nlm.nih.gov

Extracorporeal photochemotherapy in mycosis fungoides. [2018]