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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

Recruitingn/aAges 18 Years - anyAllCity of Hope Medical Center
NCT07003100 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 inf

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📋 Eligibility rules (as published)
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
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What it tests

  • Non-Interventional Study
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Where

10 sites
City of Hope Medical Center
Duarte, United States
Stanford Cancer Institute Palo Alto
Palo Alto, United States
Moffitt Cancer Center
Tampa, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, United States
Brigham and Women's Hospital
Boston, United States
Siteman Cancer Center at Washington University
St Louis, United States
Thomas Jefferson University Hospital
Philadelphia, United States

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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