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NCT05838599
Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides
EARLY_PHASE1 trial testing Imiquimod in Mycosis Fungoides in 25 participants. Status unknown.
1 August 2025
Quick facts
| Lead sponsor | Northwestern University |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 24 July 2023 |
| Primary completion | 1 August 2025 |
| Estimated completion | 1 February 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Imiquimod (IMIQUIMOD) — full drug profile →
- Radiation Therapy — full drug profile →
Conditions studied
- Mycosis Fungoides — all drugs for Mycosis Fungoides →
Sponsor
Northwestern University
Who can join
Adults 18 to 90, any sex, with Mycosis Fungoides. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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. Imiquimod stimulates a Th1 lymphocyte response with increased IL-2 and IFN-α, but also induces IFN-α, TNF-α, IL-1α, IL-6, and IL-8, thereby bridging both innate and adaptive immunity. Dosing of both radiotherapy (RT) and imiquimod are based on standard-of-care doses/frequencies for CTCL. The reason imiquimod topical is given for a week before giving RT is to prime innate immune activity for when RT is delivered. It is believed that this serves as an adjuvant for the CD8+ antitumor response generated by RT. The primary aim of this study is to assess the safety and efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Pattern recognition receptors: function, regulation and therapeutic potential.
Chen R, Zou J, Chen J, Zhong X, et al · · 2025 · cited 53× · PMID 40640149 · DOI 10.1038/s41392-025-02264-1 -
Skin-Directed Therapies in Mycosis Fungoides: An Update.
Tota M, Łyko M, Misiąg P, Łacwik J, et al · · 2025 · PMID 40810772 · DOI 10.1007/s13555-025-01511-1
Verify or expand the search:
- PubMed search for NCT05838599
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Imiquimod
Trials testing the same drug.
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- NCT05740969 — Gene and Protein Expression Profiles After Treatment of Actinic Keratoses · Phase 2 · unknown
- NCT04809662 — Comparing Immune Responses to Topical Imiquimod · terminated
- NCT03196180 — Topical Fluorouracil and Imiquimod in Treating Patients With High-Grade Cervical Intraepithelial Neoplasia · EARLY_PHASE1 · completed
- NCT03534947 — A Study to Evaluate Neoadjuvant Sonidegib Followed by Surgery or Imiquimod in the Management of Basal Cell Carcinoma · Phase 2 · completed
Other recruiting trials for Mycosis Fungoides
Currently open trials in the same condition.
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- NCT06207812 — Long-term Outcomes Associated With Juvenile-onset Mycosis Fungoides and Lymphomatoid Papulosis · recruiting
- NCT05944562 — Tulmimetostat (DZR123) in Patients With Mycosis Fungoides and Sézary Syndrome · Phase 1 · active not recruiting
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Other Northwestern University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05838599 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Northwestern University
- Last refreshed: 12 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05838599.
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