APR-TD011 Spray for Cutaneous T-Cell Lymphoma

Overseen By Dermatology CTU

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Northwestern University

Must not be taking: Antibiotics

Disqualifiers: Pregnancy, Vulnerable populations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wound cleansing spray, APR-TD011, to evaluate its effectiveness and impact on the skin's microbiome when applied to skin lesions caused by cutaneous T-cell lymphoma (CTCL). Researchers aim to determine if the spray is safe and can improve these lesions. The trial targets adults with early-stage mycosis fungoides (a type of CTCL) who have at least two skin lesions present for over three weeks and infected with staphylococcus aureus. Participants must refrain from washing or using other treatments on the target lesions before study visits. As an Early Phase 1 trial, this study focuses on understanding how the new treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on topical or systemic antibiotics during the study.

Is there any evidence suggesting that APR-TD011 spray is likely to be safe for humans?

Research shows that APR-TD011, a spray for treating certain skin conditions, is being tested for manageable side effects. This spray contains hypochlorous acid, known for killing germs and reducing inflammation.

As this treatment is in the early testing stages, limited safety information is available. Early trials primarily aim to determine if the treatment is safe for use. So far, detailed reports of negative effects are lacking, but further research is needed to confirm its safety.

Prospective participants should know that early trials are the first step in understanding a treatment's tolerability. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cutaneous T-cell lymphoma?

Unlike the standard treatments for cutaneous T-cell lymphoma, which often involve systemic therapies like chemotherapy or oral medications, APR-TD011 is a topical spray. This new delivery method allows for direct application to the affected skin areas, potentially reducing systemic side effects. Researchers are particularly excited because APR-TD011 might offer a more targeted approach, focusing on the skin lesions specific to this type of lymphoma. Additionally, being a topical treatment, it could provide a more convenient and less invasive option for patients.

What evidence suggests that APR-TD011 spray might be an effective treatment for cutaneous T-cell lymphoma?

Research shows that APR-TD011, also known as RLF-TD011, could help treat skin lesions caused by Cutaneous T-Cell Lymphoma (CTCL). Earlier studies found that it can speed up wound healing and reduce infection rates. By focusing on cleaning the affected skin, this spray might improve CTCL lesions. Although data specifically for CTCL remains limited, early results are promising. The effectiveness of the treatment will become clearer as more studies are conducted. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I agree not to use bleach, vinegar baths, or antiseptics on the target lesion during the study.

I have early-stage mycosis fungoides (stage IA or IB).

I agree not to wash or apply anything to the lesion before my study visits.

Exclusion Criteria

I have been on antibiotics recently or am currently taking them.

Adults unable to provide informed consent (infants, children, teenagers, pregnant women, prisoners, and other vulnerable populations)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Pre-treatment

Baseline assessment before treatment begins

Week 0

1 visit (in-person)

Treatment

Participants use APR-TD011® spray solution for CTCL skin lesions

8 weeks

Visits at weeks 4 and 8 (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• APR-TD011 (RLF-TD011)

Trial Overview 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.

How Is the Trial Designed?

Group I: CTCL participants Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

A study of 157 patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) showed a median overall survival of 11.5 years and a median progression-free survival of 1.2 years after first-line systemic therapy, indicating that patients can have prolonged survival despite treatment challenges.

The treatment patterns for CTCL were highly diverse, with first-line therapies including chemotherapy, retinoids, and interferon, and a notable increase in the use of new biological agents in subsequent lines of therapy, reflecting a tailored approach to patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contemporary Treatment Patterns and Response in Relapsed/Refractory Cutaneous T-Cell Lymphoma (CTCL) across Five European Countries. Assaf, C., Waser, N., Bagot, M., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05728879

Characterization of the Microbiome in Cutaneous T Cell ... This open-label, pilot study will evaluate the tolerance and change in the microbiome from the use of APR-TD011 ((RLF-TD011) wound cleansing spray for the ...

2. withpower.com withpower.com/trial/early-phase-1-lymphoma-1-2023-1589d

APR-TD011 Spray for Cutaneous T-Cell Lymphoma 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38852942/

Chart review study of real-world clinical outcomes in ... This study describes real-world treatment patterns and response rates of extracorporeal photopheresis (ECP) in CTCL patients.

4. biospace.com biospace.com/relief-therapeutics-announces-irb-approval-of-investigator-initiated-trial-evaluating-rlf-td011-as-an-adjunctive-treatment-for-cutaneous-t-cell-lymphom

Relief Therapeutics Announces IRB Approval of ... RLF-TD011 has consistently been shown to accelerate wound closure with reduced infection rates in clinical trials[5],[6],[7]. If approved in ...

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05728879?keyword=%22Cutaneous%20T-Cell%20Lymphoma%22

Characterization of the Microbiome in Cutaneous T Cell ... This open-label, pilot study will evaluate the tolerance and change in the microbiome from the use of APR-TD011 ((RLF-TD011) wound cleansing spray for the ...

6. synapse.patsnap.com synapse.patsnap.com/drug/0ce71e9c270b498f85f6f84b4e31e0cb

APR-TD011 - Drug Targets, Indications, Patents RLF-TD011 is a differentiated, hypotonic acid-oxidizing solution formulated with hypochlorous acid, designed to deliver potent antimicrobial and anti- ...

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0071861

Cutaneous T-Cell Lymphoma (CTCL) (DBCOND0071861) Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab ... APR-TD011® (RLF-TD011®) Spray ...

8. careacross.com careacross.com/clinical-trials/trial/NCT05728879

Characterization of the Microbiome in Cutaneous T Cell ... Summary: This open-label, pilot study will evaluate the tolerance and change in the microbiome from the use of APR-TD011 ((RLF-TD011) wound cleansing spray for ...