RecruitingNCT07003100

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


Sponsor

City of Hope Medical Center

Enrollment

100 participants

Start Date

Dec 6, 2024

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is observing people with a type of skin lymphoma (mycosis fungoides or Sézary syndrome) who are being treated with mogamulizumab — a standard cancer drug — to better understand a specific skin reaction called mogamulizumab-associated rash (MAR) that some patients develop. **You may be eligible if...** - You are 18 or older and have been diagnosed with relapsed or refractory mycosis fungoides (stage IB–IV) or Sézary syndrome - Your doctor has chosen to start you on mogamulizumab as a new treatment - You are willing to have a biopsy and a blood draw at the start of the study **You may NOT be eligible if...** - You are taking other systemic or skin-directed lymphoma treatments at the same time (topical steroids are fine) - You have been treated with mogamulizumab before Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNon-Interventional Study

Non-interventional study


Locations(10)

City of Hope Medical Center

Duarte, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Siteman Cancer Center at Washington University

St Louis, Missouri, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

M D Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT07003100


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