What is this study trying to find out about mycosis fungoides or sezary syndrome?

This study is assessing the occurrence of rash caused by mogamulizumab treatment in patients with mycosis fungoides or sezary syndrome. Researchers want to understand how often this rash happens and how it relates to the response to treatment. The findings may help doctors tell the difference between drug-related rash and worsening disease.

Who may be eligible for this mycosis fungoides or sezary syndrome clinical trial?

Adults aged 18 years and older diagnosed with relapsed or refractory mycosis fungoides or sezary syndrome who are starting mogamulizumab treatment may be eligible. Both men and women can participate. People cannot join if they have had prior mogamulizumab treatment or are using other systemic treatments besides topical steroids. Please review eligibility criteria for more details.

Is there any cost to participate in this mycosis fungoides or sezary syndrome clinical trial?

Study-related care, including all procedures and assessments, is provided at no cost. However, personal expenses such as travel may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Age: 18Years +

All Genders

ID07003100

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

Research Sites

N/A

Total Duration

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

Age: 18Years +

All Genders

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

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