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

Inclusion Criteria4

  • \* 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 Criteria2

  • \* Other concomitant systemic and skin directed Cutaneous T-cell Lymphoma (CTCL) regimens except for topical steroids
  • Prior treatment with mogamulizumab

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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