Status:
RECRUITING
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
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Mycosis Fungoides
Recurrent Sezary Syndrome
Eligibility:
All Genders
18+ years
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...
Detailed Description
PRIMARY OBJECTIVE: I. To assess the incidence of mogamulizumab-associated rash (MAR) and its association with overall response in patients with cutaneous T-cell lymphoma (CTCL); mycosis fungoides \[M...
Eligibility Criteria
Inclusion
- \* 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
- \* Other concomitant systemic and skin directed Cutaneous T-cell Lymphoma (CTCL) regimens except for topical steroids
- Prior treatment with mogamulizumab
Key Trial Info
Start Date :
December 6 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 19 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07003100
Start Date
December 6 2024
End Date
October 19 2026
Last Update
September 9 2025
Active Locations (10)
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1
City of Hope Medical Center
Duarte, California, United States, 91010
2
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States, 94304
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322