Apply to Trial

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

30 Participants Needed

APR-TD011 Spray for Cutaneous T-Cell Lymphoma

Overseen ByDermatology CTU

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Northwestern University

Must not be taking: Antibiotics

Disqualifiers: Pregnancy, Vulnerable populations, others

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

Trial Summary

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.

How is the APR-TD011 spray treatment different from other treatments for cutaneous T-cell lymphoma?

The APR-TD011 spray is unique because it is a topical treatment, which means it is applied directly to the skin, potentially offering a more targeted approach compared to systemic therapies that affect the whole body. This could be beneficial for patients with early-stage disease where skin-directed therapies are preferred.¹ ² ³ ⁴ ⁵

What is the purpose of this trial?

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.

Eligibility Criteria

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.

See 2 more

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

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

Treatment Details

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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: CTCL participantsExperimental Treatment1 Intervention

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

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]