A Prospective, US-Based Study Assessing Mogamulizumab-Associated Rash in Patients Diagnosed With Mycosis Fungoides or Sézary Syndrome and Treated With Standard of Care Mogamulizumab

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \* 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)

Locations
United States
California
City of Hope Medical Center
RECRUITING
Duarte
Stanford Cancer Institute Palo Alto
NOT_YET_RECRUITING
Palo Alto
Florida
Moffitt Cancer Center
NOT_YET_RECRUITING
Tampa
Georgia
Emory University Hospital/Winship Cancer Institute
NOT_YET_RECRUITING
Atlanta
Massachusetts
Brigham and Women's Hospital
NOT_YET_RECRUITING
Boston
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
NOT_YET_RECRUITING
Baltimore
Missouri
Siteman Cancer Center at Washington University
RECRUITING
St Louis
Pennsylvania
Thomas Jefferson University Hospital
NOT_YET_RECRUITING
Philadelphia
Texas
M D Anderson Cancer Center
NOT_YET_RECRUITING
Houston
Washington
Fred Hutchinson Cancer Center
NOT_YET_RECRUITING
Seattle
Time Frame
Start Date: 2024-12-06
Estimated Completion Date: 2026-10-19
Participants
Target number of participants: 100
Treatments
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.
Sponsors
Leads: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov