Recruiting

Mogamulizumab

Sponsor:

City of Hope Medical Center

Code:

NCT07003100

Conditions

Recurrent Mycosis Fungoides

Recurrent Sezary Syndrome

Refractory Mycosis Fungoides

Refractory Sezary Syndrome

Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

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).

Conditions

Recurrent Mycosis Fungoides

Recurrent Sezary Syndrome

Refractory Mycosis Fungoides

Refractory Sezary Syndrome

Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8

Study ID

NCT07003100

Start date

Dec 6, 2024

Status verified date

Aug, 2025

Completion date

Oct 19, 2026

Anticipated

Primary completion date

Oct 19, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

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.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Binary incidence of mogamulizumab-associated rash (MAR) [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Principal Investigator:

Christiane Querfeld

Siteman Cancer Center at Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator:

Neha Mehta Shah

More Information

Sponsor

City of Hope Medical Center

Last update posted

Sep 9, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2025-09-09.