Cutaneous T-cell lymphoma, a category of cancers of lymphocytes (a type of white blood cells) that primarily involve the skin, Cutaneous T-cell lymphoma (Mycosis Fungoides (MF)) and Sézary Syndrome (SS))
Conditions
Brief summary
Progression Free Survival Rate, at 48 weeks after start of mogamulizumab (PFSR-48).
Detailed description
Overall safety of both mogamulizumab and TSEB., Response rate (RR) to both mogamulizumab and TSEB. Time Frame: From the first patient treatment start till 48 weeks as of last patient in Proportion of patients achieving partial response or complete response according to EORTC-ISCL-USCLC criteria, Progression-free survival (PFS). , Overall survival (OS)., Time to progression. , Duration of response., Time to next treatment. , Exploratory endpoints: Quality of life: Skindex-29 and EORTC-QLQ-C30, and time to treatment failure.
Interventions
DRUGMOGAMULIZUMAB
Sponsors
European Organisation For Research And Treatment Of Cancer
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival Rate, at 48 weeks after start of mogamulizumab (PFSR-48). | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall safety of both mogamulizumab and TSEB., Response rate (RR) to both mogamulizumab and TSEB. Time Frame: From the first patient treatment start till 48 weeks as of last patient in Proportion of patients achieving partial response or complete response according to EORTC-ISCL-USCLC criteria, Progression-free survival (PFS). , Overall survival (OS)., Time to progression. , Duration of response., Time to next treatment. , Exploratory endpoints: Quality of life: Skindex-29 and EORTC-QLQ-C30, and time to treatment failure. | — |
Countries
Denmark, France, Germany, Greece, Italy, Spain
Outcome results
None listed