Mogamulizumab-associated rash in people with mycosis fungoides or Sézary syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective US-based observational study follows adults with relapsed or refractory mycosis fungoides or Sézary syndrome who are newly starting standard-of-care mogamulizumab. Participants complete questionnaires, have serial skin photographs taken, provide blood samples, and undergo skin biopsies when clinically indicated while investigators review medical records. The primary aim is to measure the incidence of mogamulizumab-associated rash (MAR) and analyze whether MAR is associated with overall treatment response. Collected clinical data and biospecimens will also be used to better characterize the rash and explore potential causes.

Why it matters

Who can join: the full rules

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

Where it's running

• City of Hope Medical Center
  Duarte, California, United States Recruiting
• Siteman Cancer Center at Washington University
  St Louis, Missouri, United States Recruiting
• Stanford Cancer Institute Palo Alto
  Palo Alto, California, United States Not yet recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Not yet recruiting
• Emory University Hospital/Winship Cancer Institute
  Atlanta, Georgia, United States Not yet recruiting
• Johns Hopkins University/Sidney Kimmel Cancer Center
  Baltimore, Maryland, United States Not yet recruiting

Study contacts

• Principal investigator: Christiane Querfeld — City of Hope Medical Center

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.