Actively Recruiting
A Prospective US-Based Study Assessing Mogamulizumab-Associated Rash in Patients With Mycosis Fungoides or Sezary Syndrome Treated With Standard Care Mogamulizumab
Led by City of Hope Medical Center · Updated on 2025-09-09
100
Participants Needed
10
Research Sites
N/A
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
Researchers are evaluating mogamulizumab-associated rash (MAR) in patients diagnosed with mycosis fungoides (MF) or sezary syndrome (SS), both types of cutaneous T-cell lymphoma (CTCL). The study aims to understand the incidence of MAR and how it relates to the overall response to mogamulizumab treatment. MAR is a common side effect that can resemble the skin symptoms of MF or SS but does not mean the drug is failing; it might even indicate the drug is working. Distinguishing MAR from worsening disease could prevent premature stopping of treatment and improve patient care. This is an observational study where patients receiving standard mogamulizumab treatment are followed without changing their therapy. Participants complete questionnaires, have photographs taken of their skin, and give blood samples and skin biopsies when needed to assess for MAR. Medical records are also reviewed to gather comprehensive information about their condition and treatment. Throughout the study, patients will undergo regular assessments including questionnaires, skin photography, blood draws, and skin biopsies if MAR is suspected. Researchers will monitor the occurrence of MAR over up to three years and analyze its association with treatment response. This detailed evaluation will help clarify the characteristics and causes of MAR, improving understanding of patient experiences during mogamulizumab therapy.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Diagnosed with relapsed or refractory mycosis fungoides (stage IB, IIA, IIB, III, or IV) or sezary syndrome
- Selected by their treating physician to start single-agent mogamulizumab treatment
- Signed informed consent
- Willing to have baseline and during-treatment skin biopsies if needed to evaluate rash
- Willing to provide blood samples at baseline and if rash occurs
You will not qualify if you...
- Receiving other systemic or skin-directed treatments for cutaneous T-cell lymphoma except topical steroids
- Prior treatment with mogamulizumab
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants complete questionnaires, have photographs of their skin taken, and undergo blood sample collection and skin biopsies while being observed for mogamulizumab-associated rash and treatment response.
Visits occur periodically for sample collection and assessments
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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