74 Participants Needed

Photopheresis for Mycosis Fungoides

Larisa J Geskin, MD, Cancer Care - at ...
Overseen ByLarisa J Geskin, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

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.12356

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.13457

Research Team

Larisa J Geskin, MD, Cancer Care - at ...

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.
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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.
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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
  • UVADEX® (methoxsalen) Sterile Solution
Trial OverviewThe 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
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.

THERAKOS® CELLEX photopheresis system is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as THERAKOS CELLEX photopheresis system for:
  • Cutaneous T-cell lymphoma (CTCL)
  • Sézary syndrome
  • Mycosis fungoides
🇪🇺
Approved in European Union as Extracorporeal photopheresis for:
  • Cutaneous T-cell lymphoma (CTCL)
  • Sézary syndrome
  • Mycosis fungoides

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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

The transition to the Therakos® CELLEX® fully integrated system for extracorporeal photopheresis (ECP) significantly increased the number of treatments performed annually from 225 in 2012 to 727 in 2015, demonstrating improved capacity for patient care.
Using the CELLEX® system reduced the treatment time from 270 minutes to 120 minutes per session and lowered the cost per treatment from €1,429.37 to €1,264.70, highlighting both time and cost efficiencies that can enhance patient treatment availability.
A transition from using multi-step procedures to a fully integrated system for performing extracorporeal photopheresis: A comparison of costs and efficiencies.Azar, N., Leblond, V., Ouzegdouh, M., et al.[2021]
In a study involving 14 patients with severe atopic dermatitis, long-term extracorporeal photochemotherapy (ECP) resulted in complete clinical remission for 29% of participants and substantial improvement for 36%, indicating its efficacy as a treatment option.
The treatment was found to be safe, with no significant adverse effects or signs of immunosuppression reported, suggesting that ECP could be a viable option for patients with severe and resistant cases of atopic dermatitis.
Long-term application of extracorporeal photochemotherapy in severe atopic dermatitis.Prinz, B., Michelsen, S., Pfeiffer, C., et al.[2019]
In a study of 65 patients with stage III/IV mycosis fungoides, only 35% of African-American patients received extracorporeal photopheresis (ECP) compared to 66% of Caucasian patients, indicating a significant disparity in treatment rates.
The study found that while ECP was discussed as a treatment option with 45% of African-American patients versus 82% of Caucasian patients, once it was discussed, both groups had similar rates of acceptance for the treatment (78% vs 81%).
Racial differences in the use of extracorporeal photopheresis for mycosis fungoides.Agi, C., Kuhn, D., Chung, J., et al.[2018]

References

A transition from using multi-step procedures to a fully integrated system for performing extracorporeal photopheresis: A comparison of costs and efficiencies. [2021]
Long-term application of extracorporeal photochemotherapy in severe atopic dermatitis. [2019]
Racial differences in the use of extracorporeal photopheresis for mycosis fungoides. [2018]
Erythrodermic mycosis fungoides and Sézary syndrome treated with extracorporeal photopheresis as part of a multimodality regimen: A single-centre experience. [2016]
Safety of a new, single, integrated, closed photopheresis system in patients with cutaneous T-cell lymphoma. [2013]
The use of novel Therakos™ Cellex® for extracorporeal photopheresis in treatment of graft-versus-host disease in paediatric patients. [2019]
Extracorporeal photochemotherapy in mycosis fungoides. [2018]