What side effects are associated with this type of intervention?

Monoclonal antibody treatments for Mycosis Fungoides, such as mogamulizumab, commonly cause side effects including infusion-related reactions, skin rashes, and infections. More severe side effects can include autoimmune complications and an increased risk of opportunistic infections due to immune system modulation.

What prior FDA approvals exist?

The FDA has approved several treatments for Mycosis Fungoides, including monoclonal antibodies like mogamulizumab-kpkc, which targets the CCR4 receptor on T-cells. Mogamulizumab-kpkc (POTELIGEO) was approved for the treatment of relapsed or refractory Mycosis Fungoides and Sézary syndrome, both of which are subtypes of cutaneous T-cell lymphoma. Other FDA-approved treatments include brentuximab vedotin (ADCETRIS), which targets CD30, and bexarotene (TARGRETIN), a retinoid. These treatments offer targeted therapeutic options for patients with these conditions.

What other types of research exist?

Promising novel alternatives to POTELIGEO (mogamulizumab-kpkc) for Mycosis Fungoides patients include: 1) Brentuximab vedotin, an antibody-drug conjugate targeting CD30, which has shown efficacy in MF. 2) Pembrolizumab, a PD-1 inhibitor, which has demonstrated potential in treating MF. 3) A combination of phototherapy and systemic treatments like interferons or retinoids, which can be effective in early-stage MF. These alternatives offer different mechanisms of action and have shown promise in clinical trials.

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Monoclonal Antibodies

Phototherapy + Mogamulizumab for Mycosis Fungoides (PLIGHT Trial)

Q: What is the mechanism of action of this treatment?

Mogamulizumab is a monoclonal antibody that targets the CCR4 receptor on T-cells, which is often overexpressed in Mycosis Fungoides, a type of cutaneous T-cell lymphoma. By binding to CCR4, mogamulizumab facilitates the destruction of malignant T-cells through antibody-dependent cellular cytotoxicity (ADCC). This targeted approach is significant for Mycosis Fungoides patients as it offers a more precise treatment option, potentially leading to better outcomes and fewer side effects compared to traditional therapies. Other common treatments include phototherapy, which uses ultraviolet light to induce apoptosis in malignant cells, and systemic therapies like interferons and retinoids, which modulate the immune response and cell differentiation.

Phase < 1

Recruiting

Led By Lubomir Sokol, MD, PhD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Female of childbearing potential (FCBP) must have a negative pregnancy test within 7 days of receiving study medication

Must not have

Documented prior hypersensitivity (i.e., allergic reaction) to POTELIGEO (mogamulizumab-kpkc) with a severity of Grade 2 or higher

Currently taking potential photosensitizing medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of light therapy and a drug called POTELIGEO for patients with early-stage skin cancer. The light therapy aims to improve skin conditions, while POTELIGEO helps the immune system target and destroy cancer cells.

Who is the study for?

This trial is for adults with early-stage mycosis fungoides, a type of skin lymphoma. Participants must have had stable disease or some response to previous phototherapy and can't have had major surgery or certain treatments recently. They should not have severe illnesses, other cancers within the last 2 years (with exceptions), active infections like HIV or hepatitis, known allergies to study drugs, or be pregnant.

What is being tested?

The PLIGHT study tests combining phototherapy with an immunotherapy drug called Mogamulizumab in patients with early-stage mycosis fungoides. It's an open-label pilot study where all participants receive both treatments concurrently at a single center.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as rash and itching due to phototherapy; infusion-related reactions from Mogamulizumab; fatigue; blood disorders; increased risk of infections; and potential worsening of autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I am a woman who can have children and have a recent negative pregnancy test.

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My CTCL is in early stages and tests show specific gene changes in my blood.

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I am 18 years old or older.

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I have been diagnosed with mycosis fungoides based on tests and clinical exams.

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All side effects from my previous cancer treatments are mild.

Exclusion Criteria

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

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I've had a severe allergic reaction to POTELIGEO.

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I am taking medication that may increase my sensitivity to light.

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I have had a stem cell transplant.

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I do not have any active infections needing treatment, including HIV, HTLV, Hepatitis B, or C.

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I currently have an active herpes infection.

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I have a condition that makes my skin sensitive to sunlight.

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I do not have any severe ongoing health issues like uncontrolled infections, heart problems, or diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years 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

CD4+CD26- and CD4+CD7 Change

Duration of skin response for responding subjects

Pruritus Change

+2 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: POTELIGEO & Phototherapy combination therapyExperimental Treatment2 Interventions

POTELIGEO (mogamulizumab-kpkc) will be given according to FDA approved dose and scheduled for 8 cycles. After 2 cycles of POTELIGEO, all subjects will start phototherapy as combination therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Phototherapy

2021

Completed Phase 4

~750

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Mogamulizumab is a monoclonal antibody that targets the CCR4 receptor on T-cells, which is often overexpressed in Mycosis Fungoides, a type of cutaneous T-cell lymphoma. By binding to CCR4, mogamulizumab facilitates the destruction of malignant T-cells through antibody-dependent cellular cytotoxicity (ADCC). This targeted approach is significant for Mycosis Fungoides patients as it offers a more precise treatment option, potentially leading to better outcomes and fewer side effects compared to traditional therapies. Other common treatments include phototherapy, which uses ultraviolet light to induce apoptosis in malignant cells, and systemic therapies like interferons and retinoids, which modulate the immune response and cell differentiation.

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