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Observational Study of Mogamulizumab-Associated Rash in Mycosis Fungoides and Sezary Syndrome

This study is looking at a common skin rash that can happen when patients with Mycosis Fungoides (MF) or Sezary Syndrome (SS) are treated with a medication called mogamulizumab. This rash, called mogamulizumab-associated rash (MAR), can sometimes look like the original skin condition, but it doesn't mean the treatment isn't working. In fact, it might even be a sign that the medication is effective. Doctors want to understand MAR better so they don't mistakenly stop mogamulizumab treatment too early. You might be able to join if you are an adult (18 or older) with relapsed or refractory MF (stages IB, IIA, IIB, III, IV) or SS, and your doctor has decided to start you on mogamulizumab.

Study design
This is an observational study planning to enroll 100 participants. It is not testing a new treatment, but rather observing patients receiving standard care.
What's involved
You would complete questionnaires, have skin photographs taken, and provide blood samples and skin biopsies. Your medical records would also be reviewed.
Compensation
Not stated in the trial record.
Follow-up
The incidence of rash will be measured for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07003100

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
Not specifiedAges 18+Observational
City of Hope Medical Center
~100 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:Non-Interventional Study

At a glance

Recruiting sites
2 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Binary incidence of mogamulizumab-associated rash (MAR)
Measured over Up to 3 years

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

Explore related trials

Mycosis FungoidesSezary Syndrome

NCT07003100

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Brigham and Women's Hospital

    Boston, Massachusettsstudy coordinator listed

    Not yet recruiting

  • City of Hope Medical Center

    Duarte, Californiastudy coordinator listed

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgiastudy coordinator listed

    Not yet recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washingtonstudy coordinator listed

    Not yet recruiting

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Marylandstudy coordinator listed

    Not yet recruiting

  • M D Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Not yet recruiting

  • Moffitt Cancer Center

    Tampa, Floridastudy coordinator listed

    Not yet recruiting

  • Siteman Cancer Center at Washington University

    St Louis, Missouristudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Christiane Querfeld · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Christiane Querfeld
[email protected]
626-218-9018
Email the study team

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Eligibility criteria

Inclusion

\* 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

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

What this trial measures

  • 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.