Clinical Trial Details
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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
