Actively Recruiting
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
Led by City of Hope Medical Center · Updated on 2025-09-09
100
Participants Needed
10
Research Sites
97 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (18 years or older) diagnosed with relapsed or refractory mycosis fungoides (MF) stage IB, IIA, IIB, III, or IV or sezary syndrome (SS).
- Selected by their treating physician to receive single agent mogamulizumab (newly initiated).
- Signed informed consent.
- Willing to undergo baseline biopsy and biopsies during treatment if mogamulizumab-associated rash (MAR) is suspected.
- Willing to provide blood samples at baseline and if MAR occurs.
You will not qualify if you...
- Receiving other systemic or skin-directed cutaneous T-cell lymphoma (CTCL) treatments except for topical steroids.
- Prior treatment with mogamulizumab.
AI-Screening
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Trial Site Locations
Total: 10 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States, 94304
Not Yet Recruiting
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Not Yet Recruiting
4
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
5
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
6
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
7
Siteman Cancer Center at Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
8
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Not Yet Recruiting
9
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
10
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Not Yet Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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