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

Recruiting

• Conditions: Recurrent Mycosis Fungoides; Recurrent Sezary Syndrome; Refractory Mycosis Fungoides; Refractory Sezary Syndrome; Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8; Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v8; Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8; Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8; Stage IV Mycosis Fungoides and Sezary Syndrome AJCC v8

• Registration Number: NCT07003100
• Lead Sponsor: City of Hope Medical Center

Brief 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).

Detailed Description

PRIMARY OBJECTIVE:

I. To assess the incidence of mogamulizumab-associated rash (MAR) and its association with overall response in patients with cutaneous T-cell lymphoma (CTCL); mycosis fungoides \[MF\] and sezary syndrome \[SS\] subtypes) treated with mogamulizumab.

OUTLINE: This is an observational study.

Patients complete questionnaires, have photographs of their skin taken, and undergo blood sample collection and skin biopsies on study. Patients' medical records are also reviewed.

Study Timeline

• Study Start: 2024-12-06
• Study First Submitted: 2025-05-21
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-02
• Last Update Submitted: 2025-06-02
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Primary Completion: 2026-10-19
• Study Completion: 2026-10-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Binary incidence of mogamulizumab-associated rash (MAR)	Up to 3 years	Will be estimated as a binomial proportion along with the 95% exact binomial confidence interval.

Trial Locations

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; 🇺🇸 Saint 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