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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

* 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)

Disqualifiers

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

Prior treatment with mogamulizumab

Trial population

Patients 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Non-Interventional Study

    Other intervention

    Non-interventional study

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Observational1 intervention

Trial outcomes

Primary outcomes

1

Binary incidence of mogamulizumab-associated rash (MAR)

Will be estimated as a binomial proportion along with the 95% exact binomial confidence interval.

Time frame
Up to 3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator