Mycosis FungoidesEarly Phase 1NCT05838599
Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides
A Early Phase 1 study testing Imiquimod and Radiation Therapy in people with Mycosis Fungoides, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mycosis Fungoides
- What is being tested?
- Imiquimod and Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2023to 1 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have confirmed stage IA-IIB mycosis fungoides.
- Patients must be 18-90 years of age.
- Patients must have failed at least one standard therapy for MF.
- Patients must have active, but stable disease for >6 months.
- Patients must have 4 or more discrete MF lesions with at least 2 of them with minimum combined surface area of >50cm2.
- POCBP must have a negative pregnancy test prior to registration on study.
- Patients must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who are on current systemic or topical CTCL therapy, unless stable on the treatment for >6 months.
- Patients who have received antibiotic therapy within 4 weeks of study enrollment.
- Patients who are pregnant or nursing. Pregnant people are excluded from this study because IMQ is an agent with potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the gestational parent with IMQ, breastfeeding should be discontinued if the parent is treated with IMQ.
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
Dermatology CTU
About this study
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
- Mycosis Fungoides
- Being tested
- Imiquimod, Radiation Therapy
- Medical subject headings
- Mycosis Fungoides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImiquimodDrug
5% cream applied topically 5 days/week for 6 weeks
Radiation TherapyRadiation
2 fractions of 4 Gys (total of 8 Gys) starting 1 week after Imiquimoid course over 2 days.
| Study group | Role | What they receive |
|---|---|---|
| Topical IMQ and localized RT | Experimental | After the initial study visit, patients will immediately begin use of imiquimod cream at designated lesions (those with combined size >50cm2) nightly for 5 consecutive days a week over 6 weeks. One week into the imiquimod treatment course, radiation therapy will be administered at Northwestern Medicine by radiation oncologists familiar with MF in 2 fractions of 4 Gy (total 8 Gy) over 2 days to the same designated lesions. Receives: Drug: Imiquimod; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF as measured by mSWAT at week 8.
The primary efficacy endpoint will be skin disease response as measured by mSWAT (Modified Severity-Weighted Assessment Tool) at week 8.
Measured: 8 weeks
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.
Adverse event occurrence during study.
Measured: 12 weeks
Secondary outcomes (2)
Microbiome alterations before and after treatment
To measure alterations in lesional (tumor-associated) skin, nasal, and gut microbiomes before and after combination RT/imiquimod treatment and associate these differences in microbiomes with clinical response (and any toxicity). Differences in microbiome bacterial species will be measured by alpha and beta diversity metrics. Alpha diversity quantifies within sample diversity. Beta diversity compares between sample diversity (before and after treatment).
Measured: 12 weeks
Tumor-associated and serum immune alterations before and after treatment
To correlate quantitative changes in tumor-associated and serum immune response profiles with clinical response to RT/imiquimod treatment (and any toxicity).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start24 Jul 2023
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycosis FungoidesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaolong (Alan) Zhou, Northwestern University
- Investigators
- Alan Zhou, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838599
- Sponsor's protocol ID
- AZ10312022
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides
- ClinicalTrials.gov ID
- NCT05838599
- Acronym / sponsor ID
- AZ10312022
- Conditions
- Mycosis Fungoides
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topical IMQ and localized RT | Experimental | Drug: Imiquimod, Radiation: Radiation TherapyAfter the initial study visit, patients will immediately begin use of imiquimod cream at designated lesions (those with combined size >50cm2) nightly for 5 consecutive days a week over 6 weeks. One week into the imiquimod treatment course, radiation therapy will be administered at Northwestern Medicine by radiation oncologists familiar with MF in 2 fractions of 4 Gy (total 8 Gy) over 2 days to the same designated lesions. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have confirmed stage IA-IIB mycosis fungoides.
- Patients must be 18-90 years of age.
- Patients must have failed at least one standard therapy for MF.
- Patients must have active, but stable disease for >6 months.
- Patients must have 4 or more discrete MF lesions with at least 2 of them with minimum combined surface area of >50cm2.
Key exclusion criteria (4 listed)
- Patients who are on current systemic or topical CTCL therapy, unless stable on the treatment for >6 months.
- Patients who have received antibiotic therapy within 4 weeks of study enrollment.
- Patients who are pregnant or nursing. Pregnant people are excluded from this study because IMQ is an agent with potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the gestational parent with IMQ, breastfeeding should be discontinued if the parent is treated with IMQ.
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imiquimod5% cream applied topically 5 days/week for 6 weeks | Drug | Topical IMQ and localized RT |
| Radiation Therapy2 fractions of 4 Gys (total of 8 Gys) starting 1 week after Imiquimoid course over 2 days. | Radiation | Topical IMQ and localized RT |
Primary outcome
Efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF as measured by mSWAT at week 8.
Time frame: 8 weeks
The primary efficacy endpoint will be skin disease response as measured by mSWAT (Modified Severity-Weighted Assessment Tool) 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.
Time frame: 12 weeks
Adverse event occurrence during study.
2 secondary outcomes
Microbiome alterations before and after treatment
Time frame: 12 weeks
Tumor-associated and serum immune alterations before and after treatment
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alan Zhou principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Imiquimod and Radiation Therapy in people with Mycosis Fungoides, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dermatology Clinical Trials Unit (312-503-5944, NUderm-research@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF as measured by mSWAT at week 8. (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.