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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 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.
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.
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- DRUG Imiquimod
Study Locations (1)
Illinois
- Northwestern University Department of Dermatology - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-07-24 |
| Est. Completion | 2026-02-01 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05838599
The ClinicalTrials.gov registry entry for NCT05838599 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 162-participant average among 19 other Mycosis Fungoides trials with a reported enrollment target (85% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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