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

Last updated: August 27, 2025
Sponsor: City of Hope Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sezary Syndrome

Mycosis Fungoides

Lymphoproliferative Disorders

Treatment

Non-Interventional Study

Clinical Study ID

NCT07003100
22233
22233
P30CA033572
NCI-2024-01011
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

    • Adult patients (>= 18 years of age) diagnosed with relapsed/refractory MycosisFungoides (MF) stage IB, IIA, IIB, III and IV or Sezary Syndrome(SS), and selectedby their treating physician to receive single agent mogamulizumab (newly initiated)
  • Signed informed consent

  • Willing to undergo baseline biopsy and during treatment to evaluate forMogamulizumab-Associated Rash (MAR) if clinically indicated

  • Willing to provide blood sample at baseline, and if applicable, at onset ofMogamulizumab-Associated Rash (MAR)

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Non-Interventional Study
Phase:
Study Start date:
December 06, 2024
Estimated Completion Date:
October 19, 2026

Study 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.

Connect with a study center

  • City of Hope Medical Center

    Duarte, California 91010
    United States

    Site Not Available

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California 94304
    United States

    Site Not Available

  • City of Hope Medical Center

    Duarte 5344147, California 5332921 91010
    United States

    Active - Recruiting

  • Stanford Cancer Institute Palo Alto

    Palo Alto 5380748, California 5332921 94304
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Emory University Hospital/Winship Cancer Institute

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Site Not Available

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Siteman Cancer Center at Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Siteman Cancer Center at Washington University

    St Louis 4407066, Missouri 4398678 63110
    United States

    Active - Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • M D Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Site Not Available

  • Fred Hutchinson Cancer Center

    Seattle 5809844, Washington 5815135 98109
    United States

    Site Not Available

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