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NCT05838599 · ClinicalTrials.gov registry record · Early Phase 1

Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides

A Early Phase 1 study of Mycosis Fungoides, sponsored by Northwestern University.

Recruiting
Registry status
Early Phase 1
Development phase
25
Enrollment target
1
Study location

NCT05838599: Recruiting Early Phase 1 study of Mycosis Fungoides, sponsored by Northwestern University.

NCT05838599 is a Early Phase 1 study of Mycosis Fungoides that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 25 participants, below the 162-participant average among 19 other Mycosis Fungoides trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05838599, a Early Phase 1 study of Mycosis Fungoides, is actively recruiting participants, sponsored by Northwestern University.

RECRUITING
Registry status
Early Phase 1
Development phase
25 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

The primary efficacy endpoint will be skin disease response as measured by mSWAT (Modified Severity-Weighted Assessment Tool) at week 8.

Conditions Studied

Interventions

  • RADIATION Radiation Therapy
  • DRUG Imiquimod

Study Locations (1)

Illinois

  • Northwestern University Department of Dermatology - Chicago

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2023-07-24
Est. Completion 2026-02-01
Phase Early Phase 1
Northwestern University

1,209 total trials

What NCT05838599 shows while recruiting

NCT05838599 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 162-participant average among 19 other Mycosis Fungoides trials with a reported enrollment target (85% lower).

The record links to 1 condition, with Mycosis Fungoides appearing as the primary indexed condition, and to 2 interventions - of which Radiation Therapy is the first listed.

NCT05838599 reports a single indexed study location in Illinois.

Frequently Asked Questions

What is clinical trial NCT05838599 about?

NCT05838599 is a clinical study titled "Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides". 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 ly...

What is the current status of trial NCT05838599?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 25 participants. The study started on 2023-07-24. Estimated completion is 2026-02-01.

What conditions does trial NCT05838599 study?

This clinical trial studies the following conditions: Mycosis Fungoides.

What interventions are being tested in trial NCT05838599?

The interventions under investigation include: Radiation Therapy (RADIATION), Imiquimod (DRUG).

Who is sponsoring clinical trial NCT05838599?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05838599 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Mycosis Fungoides

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05838599's enrollment target sits among peer trials

25 14th of 19 higher than 6 of 19 other Mycosis Fungoides trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Mycosis Fungoides trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05838599, the US trial registry maintained by the National Library of Medicine. NCT05838599 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.