rare disease
Conditions
Brief summary
The main study endpoint is progression-free survival at 2 years after randomization. Progression/relapse will be defined according to the ISCL/EORTC criteria, and assessed in a double-blind setting.
Detailed description
Overall survival (OS), 1-year variation in quality-of-life scores (EORTC- QLQ-C30 & Skindex-29), Cumulative incidence of disease relapse, Cumulative incidence of acute graft-versus-host disease (GVHD), Cumulative incidence of chronic GVHD, Cumulative incidence of non-relapse mortality, 2-year variation in quality-of-life scores (EORTC-QLQ-C30 and Skindex-29), Skin tumour microenvironment at baseline, 3 months and at relapse/progression if any
Interventions
DRUGPlacebo ADCETRIS ( NaCl 0.9% 100 mL - Injection IV )
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is progression-free survival at 2 years after randomization. Progression/relapse will be defined according to the ISCL/EORTC criteria, and assessed in a double-blind setting. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), 1-year variation in quality-of-life scores (EORTC- QLQ-C30 & Skindex-29), Cumulative incidence of disease relapse, Cumulative incidence of acute graft-versus-host disease (GVHD), Cumulative incidence of chronic GVHD, Cumulative incidence of non-relapse mortality, 2-year variation in quality-of-life scores (EORTC-QLQ-C30 and Skindex-29), Skin tumour microenvironment at baseline, 3 months and at relapse/progression if any | — |
Countries
France
Outcome results
None listed