Mycosis fungoides/Sezary syndrome recurrent
Conditions
Brief summary
•Percentage of participants experiencing treatment-emergent adverse events. • Changes in laboratory analyses, physical examinations, vital signs, and ECGs.
Detailed description
• Serum concentrations of mogamulizumab and other PK parameters. • ORR and compartment response will be assessed as described by Olsen (2011). • DOR will be calculated from first response to progression or death • Detection of anti-drug antibodies (ADAs) to mogamulizumab and incidence of ADAs. • Tissue samples will be assessed for changes in CCR4, CD4, and CD8 expression., • Blood samples will be assessed for circulating malignant T-cells
Interventions
DRUGPOTELIGEO 4 mg/mL concentrate for solution for infusion
Sponsors
Kyowa Kirin Inc., Kyowa Kirin Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Percentage of participants experiencing treatment-emergent adverse events. • Changes in laboratory analyses, physical examinations, vital signs, and ECGs. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Serum concentrations of mogamulizumab and other PK parameters. • ORR and compartment response will be assessed as described by Olsen (2011). • DOR will be calculated from first response to progression or death • Detection of anti-drug antibodies (ADAs) to mogamulizumab and incidence of ADAs. • Tissue samples will be assessed for changes in CCR4, CD4, and CD8 expression., • Blood samples will be assessed for circulating malignant T-cells | — |
Countries
France, Spain
Outcome results
None listed