What side effects are associated with this type of intervention?

Common treatments for Cutaneous T-Cell Lymphoma (CTCL) that involve topical applications and microbiome alterations include topical corticosteroids, retinoids, and phototherapy. These treatments can cause side effects such as skin irritation, redness, increased sensitivity to sunlight, dryness, peeling, and a burning sensation. Prolonged use of topical corticosteroids may lead to skin thinning and stretch marks, while long-term phototherapy can increase the risk of skin cancer. For treatments like APR-TD011 wound cleansing spray, potential side effects to monitor include skin irritation and allergic reactions.

What prior FDA approvals exist?

FDA-approved treatments for Cutaneous T-Cell Lymphoma (CTCL) include topical therapies, systemic therapies, and biologics. Notable treatments include topical corticosteroids, mechlorethamine gel, and bexarotene gel, which are used to manage skin lesions. Systemic treatments such as vorinostat and romidepsin, both histone deacetylase inhibitors, are used for more advanced stages. Additionally, mogamulizumab, a monoclonal antibody targeting CCR4, has been approved for CTCL. While these treatments differ from the wound-cleansing and microbiome-altering approach of APR-TD011 (RLF-TD011), they highlight the diverse strategies employed in managing CTCL.

What other types of research exist?

Promising novel alternatives for CTCL treatment in 2024 include: 1) Topical ruxolitinib, which has shown efficacy in reversing alopecia areata and may have potential in CTCL due to its anti-inflammatory properties. 2) Photodynamic therapy (PDT), which involves the use of light-sensitive compounds and light exposure to target cancer cells. 3) Low-level laser therapy (LLLT), which has been reported to improve healing and symptoms in various skin conditions. These alternatives may offer new avenues for managing CTCL skin lesions and altering the skin microbiome.

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APR-TD011 Spray for Cutaneous T-Cell Lymphoma

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

Common treatments for Cutaneous T-Cell Lymphoma (CTCL) include topical corticosteroids, phototherapy, and topical retinoids. Topical corticosteroids reduce inflammation and suppress the immune response in the skin, which helps to control the proliferation of malignant T-cells. Phototherapy, such as PUVA (psoralen plus ultraviolet A), involves the use of light to induce apoptosis in malignant cells. Topical retinoids, like bexarotene, modulate cell differentiation and proliferation. These treatments are significant for CTCL patients as they target the skin directly, where the lymphoma manifests, and can help manage symptoms and slow disease progression. The potential of treatments like APR-TD011 (RLF-TD011) to alter the skin microbiome may offer additional benefits by improving the skin's overall health and potentially reducing secondary infections.

Phase < 1

Waitlist Available

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special spray that cleans wounds on patients with a type of skin cancer called CTCL. The goal is to see if the spray is well-tolerated and if it changes the bacteria on the skin. The spray could help improve the condition of the skin lesions.

Who is the study for?

This trial is for adults with early-stage mycosis fungoides, a type of cutaneous T-cell lymphoma. Participants must have at least two skin lesions present for over three weeks and one lesion positive for staphylococcus aureus that doesn't need systemic antibiotics. They should not wash or apply anything to the lesion before visits and avoid antiseptic baths during the study.

What is being tested?

The trial tests APR-TD011 (RLF-TD011) spray solution's effect on skin lesions caused by cutaneous T-cell lymphoma, specifically looking at how it changes the microbiome in these lesions and its tolerance when applied directly.

What are the potential side effects?

While specific side effects are not listed, as this is an open-label pilot study focusing on tolerance, potential side effects may include local reactions like irritation or allergic responses where the spray is applied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in microbiome species

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: CTCL participantsExperimental Treatment1 Intervention

Visits will include screening, pre-treatment (week 0), weeks 4 and 8.

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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

Common treatments for Cutaneous T-Cell Lymphoma (CTCL) include topical corticosteroids, phototherapy, and topical retinoids. Topical corticosteroids reduce inflammation and suppress the immune response in the skin, which helps to control the proliferation of malignant T-cells. Phototherapy, such as PUVA (psoralen plus ultraviolet A), involves the use of light to induce apoptosis in malignant cells. Topical retinoids, like bexarotene, modulate cell differentiation and proliferation. These treatments are significant for CTCL patients as they target the skin directly, where the lymphoma manifests, and can help manage symptoms and slow disease progression. The potential of treatments like APR-TD011 (RLF-TD011) to alter the skin microbiome may offer additional benefits by improving the skin's overall health and potentially reducing secondary infections.