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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Page 1 of 3 (10 locations)

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