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Early Phase 1
Age: 18Years - 90Years
All Genders
ID05838599

Treatment Study Combining Topical Imiquimod Cream and Local Radiation Therapy for Mycosis Fungoides Evaluating Safety and Effectiveness in Adult Patients

Led by Northwestern University · Updated on 2026-05-01

25

Participants Needed

1

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a combination treatment using topical imiquimod cream and local radiotherapy for patients with mycosis fungoides MF, the most common type of cutaneous T cell lymphoma. This trial focuses on patients with conventional CD4 MF who have active but stable disease and have previously not responded to at least one standard therapy. The study aims to assess the safety and effectiveness of this combined approach in treating MF skin lesions. Participants will apply 5% imiquimod cream to selected lesions five days a week for six weeks. One week after starting imiquimod, they will receive radiation therapy to the same lesions, delivered in two doses of 4 Gy each over two days. This schedule is designed so that imiquimod primes the immune system before radiation is given, potentially enhancing the anti-tumor response. During the study, patients will be monitored for treatment effects and safety through assessments at 8 and 12 weeks, including measuring skin lesion severity using the modified Severity Weighted Assessment Tool mSWAT. Researchers will also analyze changes in the microbiome and immune markers in tumors and blood. The study participation lasts through initial treatment and follow-up, with careful observation for any side effects or responses to the therapy.

CONDITIONS

Brief Title

Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides

Research Team

D

Dermatology Clinical Trials Unit

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