Mogamulizumab-associated rash in people with mycosis fungoides or Sézary syndrome
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
See if a rash that appears while taking mogamulizumab is a drug-related rash and how it links to treatment response in adults with relapsed or refractory mycosis fungoides or Sézary syndrome.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | mogamulizumab |
| Locations | 10 sites (Duarte, California and 9 other locations) |
| Trial ID | NCT07003100 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with relapsed or refractory mycosis fungoides or Sézary syndrome who are about to start single-agent mogamulizumab and are willing to undergo biopsies, blood draws, photos, and questionnaires.
Not a fit: Patients previously treated with mogamulizumab, those receiving other systemic CTCL therapies, or those unwilling to provide biopsies or blood samples are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the study could help clinicians tell drug-related rash apart from disease progression, reducing unnecessary early stopping of mogamulizumab and improving patient management.
How similar studies have performed: Case reports and retrospective series have described mogamulizumab-associated rash and suggested possible links with response, but prospective, multicenter US studies characterizing MAR are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Duarte, California and 9 other locations
- City of Hope Medical Center — Duarte, California, 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)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- Siteman Cancer Center at Washington University — St Louis, Missouri, United States (Recruiting)
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- M D Anderson Cancer Center — Houston, Texas, United States (Not_yet_recruiting)
- Fred Hutchinson Cancer Center — Seattle, Washington, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Christiane Querfeld — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.