Clinical trial · Observational
A Prospective, US-based Study Assessing Mogamulizumab-associated Rash in Patients Diagnosed With Mycosis Fungoides or Sezary Syndrome and Treated With Standard of Care Mogamulizumab
A Prospective, US-Based Study Assessing Mogamulizumab-Associated Rash in Patients Diagnosed With Mycosis Fungoides or Sézary Syndrome and Treated With Standard of Care Mogamulizumab
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
This study is being done to assess mogamulizumab-associated rash in patients diagnosed with mycosis fungoides or sezary syndrome and treated with standard of care mogamulizumab. One of the most common side effects of mogamulizumab is a rash, currently named mogamulizumab-associated rash (MAR) which can look like MF or SS. However, mogamulizumab-associated rash (MAR) does not indicate failure of mogamulizumab, and may be a sign that the drug is working. If not properly evaluated, mogamulizumab-associated rash (MAR) could be misinterpreted as worsening of mycosis fungoides/sezary syndrome, which could lead doctors to recommend stopping mogamulizumab treatment early. The information learned by doing this research study may help tell the difference between mogamulizumab-associated rash (MAR) (sometimes also called "drug eruption") and worsening of the disease. It may also help to uncover information about the cause of mogamulizumab-associated rash (MAR).
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Mycosis Fungoides | Mycosis Fungoides | CURATED_BROADER | 0.78 |
| Recurrent Sezary Syndrome | Sezary Syndrome | CURATED_BROADER | 0.78 |
| Refractory Mycosis Fungoides | Mycosis Fungoides | CURATED_BROADER | 0.78 |
| Refractory Sezary Syndrome | Sezary Syndrome | CURATED_BROADER | 0.78 |
| Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8 | Mycosis Fungoides and Sezary Syndrome | CURATED_BROADER | 0.78 |
| Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v8 | Mycosis Fungoides and Sezary Syndrome | CURATED_BROADER | 0.78 |
| Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8 | Mycosis Fungoides and Sezary Syndrome |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational
- description
- Patients complete questionnaires, have photographs of their skin taken, and undergo blood sample collection and skin biopsies on study. Patients' medical records are also reviewed.
- interventionNames
- Other: Non-Interventional Study
Primary outcomes (1)
- measure
- Binary incidence of mogamulizumab-associated rash (MAR)
- timeFrame
- Up to 3 years
- description
- Will be estimated as a binomial proportion along with the 95% exact binomial confidence interval.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \* Adult patients (\>= 18 years of age) diagnosed with relapsed/refractory Mycosis Fungoides (MF) stage IB, IIA, IIB, III and IV or Sezary Syndrome(SS), and selected by their treating physician to receive single agent mogamulizumab (newly initiated) * Signed informed consent * Willing to undergo baseline biopsy and during treatment to evaluate for Mogamulizumab-Associated Rash (MAR) if clinically indicated * Willing to provide blood sample at baseline, and if applicable, at onset of Mogamulizumab-Associated Rash (MAR) Exclusion Criteria: * \* Other concomitant systemic and skin directed Cutaneous T-cell Lymphoma (CTCL) regimens except for topical steroids * Prior treatment with mogamulizumab
References
Publications (0)
Data not yet available