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
| NCT ID | NCT07003100 |
| Status | Recruiting |
| Phase | — |
| Sponsor | City of Hope Medical Center |
| Condition | Recurrent Mycosis Fungoides |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-12-06 |
| Primary Completion | 2026-10-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-12-06 with a primary completion date of 2026-10-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Christiane Querfeld
PRINCIPAL INVESTIGATOR
City of Hope Medical Center
Frequently Asked Questions
Who can join the NCT07003100 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Recurrent Mycosis Fungoides. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07003100 currently recruiting?
Yes, NCT07003100 is actively recruiting participants. Visit ClinicalTrials.gov or contact City of Hope Medical Center to inquire about joining.
Where is the NCT07003100 trial being conducted?
This trial is being conducted at Duarte, United States, Palo Alto, United States, Tampa, United States, Atlanta, United States and 6 additional locations.
Who is sponsoring the NCT07003100 clinical trial?
NCT07003100 is sponsored by City of Hope Medical Center. The principal investigator is Christiane Querfeld at City of Hope Medical Center. The trial plans to enroll 100 participants.