NCT07003100

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

PRIMARY OBJECTIVE: I. To assess the incidence of mogamulizumab-associated rash (MAR) and its association with overall response in patients with cutaneous T-cell lymphoma (CTCL); mycosis fungoides \[MF\] and sezary syndrome \[SS\] subtypes) treated with mogamulizumab. OUTLINE: This is an observational study. 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.

Conditions

• Recurrent Mycosis Fungoides
• Recurrent Sezary Syndrome
• Refractory Mycosis Fungoides
• Refractory Sezary Syndrome
• Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8
• Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v8
• Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8
• Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8
• Stage IV Mycosis Fungoides and Sezary Syndrome AJCC v8

Interventions

Type	Name	Description
OTHER	Non-Interventional Study	Non-interventional study

Timeline

• Start date: 2024-12-06
• Primary completion: 2026-10-19
• Completion: 2026-10-19
• First posted: 2025-06-04
• Last updated: 2025-09-09

Locations

10 sites across 1 country: United States