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Phase N/AObservational

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

Protocol: STUDY00008510

Overview

Primary Objective:

  • 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 [MF] and Sézary Syndrome [SS] subtypes) treated with mogamulizumab

Secondary Objectives:

  • To describe the characteristics and treatment patterns of MAR, and outcomes of MAR management protocol
  • To assess clinical outcomes (response, duration of response (DOR), progression free survival (PFS), and time to next significant lymphoma therapy (TTNL)) in
    patients with CTCL treated with mogamulizumab in the real-world setting
  • To assess all serious adverse events (SAEs) of patients with CTCL treated with mogamulizumab in
    the real-world setting.
  • To assess the association of MAR with DOR, TTNT and PFS

Exploratory Objectives:

  • To analyze the CTCL tumor microenvironment using paired single-cell RNA and T-cell receptor (TCR) analysis
  • To explore biomarkers that will predict clinical outcomes
  • To evaluate patient reported symptoms and quality of life
Investigators
Location
Winship Cancer Institute