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Early Phase 1RecruitingPriority 4 · Lower priorityNCT05838599

Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides

ClinicalTrials.gov

Plain-language summary

This trial is testing Imiquimod for patients with cutaneous T-cell lymphoma (CTCL), including mycosis fungoides or Sézary syndrome at various stages of their disease. This is an early Phase 1 trial, which means this is among the first tests of the treatment in patients, focusing on safety and dose. The study looks at both safety and how well the treatment controls the lymphoma. This trial is available at 1 location in the United States. The trial is currently recruiting patients.

Who can join (key eligibility)

  • Age 18 Years to 90 Years years
  • See full trial listing for complete eligibility

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

Imiquimod (DRUG): 5% cream applied topically 5 days/week for 6 weeks | Radiation Therapy (RADIATION): 2 fractions of 4 Gys (total of 8 Gys) starting 1 week after Imiquimoid course over 2 days.

  • Imiquimod, Radiation Therapy

Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

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TrialCompass — Clinical Trial Summary

Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides

NCT05838599

Phase: Early Phase 1 | Status: Recruiting | Priority: Lower

Plain-language summary

This trial is testing Imiquimod for patients with cutaneous T-cell lymphoma (CTCL), including mycosis fungoides or Sézary syndrome at various stages of their disease. This is an early Phase 1 trial, which means this is among the first tests of the treatment in patients, focusing on safety and dose. The study looks at both safety and how well the treatment controls the lymphoma. This trial is available at 1 location in the United States. The trial is currently recruiting patients.

Who can join

  • Age 18 Years to 90 Years years
  • See full trial listing for complete eligibility

What's being tested

Imiquimod (DRUG): 5% cream applied topically 5 days/week for 6 weeks | Radiation Therapy (RADIATION): 2 fractions of 4 Gys (total of 8 Gys) starting 1 week after Imiquimoid course over 2 days.

Drugs / treatments: Imiquimod, Radiation Therapy

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 25 patients

Primary endpoint: Efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF as measured by mSWAT at week 8.; Incidence of treatment-emergent adverse events (safety and tolerability) of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF.

Ages: 18 Years to 90 Years

Start date: 2023-07-24 | Est. completion: 2027-12-01

Locations

1 US sites · 1 total

Illinois

Contact

Dermatology Clinical Trials Unit | NUderm-research@northwestern.edu | 312-503-5944

Sponsor: Northwestern University (OTHER)

Tags

CTCL · any

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT05838599

Prepared using TrialCompass (trialcompass.com) on August 3, 2026. For informational purposes only. Always discuss with your healthcare team.