Recruiting EARLY_PHASE1 Mycosis Fungoides

New treatment option for Mycosis Fungoides

Official title Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides

ClinicalTrials.gov ID: NCT05838599

What this study is testing

What is Imiquimod?

Imiquimod is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for mycosis fungoides.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Mycosis fungoides (MF) is the most common subtype of cutaneous T cell lymphoma (MF) and presents as cutaneous patches, plaques, and tumors. Radiation therapy (RT) is a frequently pursued management option for CTCL, especially in patients with more advanced skin disease.
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 90

You may be able to join if

  • Patients must have confirmed stage IA-IIB mycosis fungoides.
  • Patients must be 18-90 years of age.
  • Patients must have failed at least one standard therapy for MF.
  • Patients must have active, but stable disease for \>6 months.
  • Patients must have 4 or more discrete MF lesions with at least 2 of them with minimum combined surface area of \>50cm2.

You likely can't join if

  • Patients who are on current systemic or topical CTCL therapy, unless stable on the treatment for \>6 months.
  • Patients who have received antibiotic therapy within 4 weeks of study enrollment.
  • Patients who are pregnant or nursing. Pregnant people are excluded from this study because IMQ is an agent with potential for teratogenic or...
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements.
See the full eligibility criteria
Who can join
  • Patients must have confirmed stage IA-IIB mycosis fungoides.
  • Patients must be 18-90 years of age.
  • Patients must have failed at least one standard therapy for MF.
  • Patients must have active, but stable disease for \>6 months.
  • Patients must have 4 or more discrete MF lesions with at least 2 of them with minimum combined surface area of \>50cm2.
  • POCBP must have a negative pregnancy test prior to registration on study.
  • Patients must have the ability to understand and the willingness to sign a written informed consent document.
What rules you out
  • Patients who are on current systemic or topical CTCL therapy, unless stable on the treatment for \>6 months.
  • Patients who have received antibiotic therapy within 4 weeks of study enrollment.
  • Patients who are pregnant or nursing. Pregnant people are excluded from this study because IMQ is an agent with potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for...
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements.

The study team makes the final eligibility decision.

Where it's taking place

  • Chicago, Illinois, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.