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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Non-Interventional Study — OTHER
  Non-interventional study

Study Details

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).

Key Dates

Start date

Dec 6, 2024

Status verified

Aug 2025

Primary completion

Oct 19, 2026

Completion

Oct 19, 2026

Study Design

Enrollment

100 participants (estimated)

Arms

• Arm: Observational
  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.

Primary Outcome Measure

Binary incidence of mogamulizumab-associated rash (MAR) [ Time Frame: Up to 3 years ]

Locations (10)

Find similar trials in Duarte, CA

Related Studies

• Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma
  PHASE2 · Recruiting · City of Hope Medical Center · Scottsdale, Arizona
• Low-Dose Total Skin Electron Therapy in Treating Patients With Refractory or Relapsed Stage IB-IIIA Mycosis Fungoides
  Recruiting · Vanderbilt-Ingram Cancer Center · Nashville, Tennessee
• A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma
  PHASE1 · Recruiting · Mayo Clinic · Scottsdale, Arizona