IN RELAPSED/REFRACTORY PATIENTS WITH PERIPHERAL T-CELL LYMPHOMA
Conditions
Brief summary
modified PFS (mPFS), defined as time from randomization until one of the following events occurs, whichever comes first: a) Disease progression (PD) b) Administration of any additional unplanned anti-lymphoma treatment (except allogeneic or autologous hematopoietic cell transplantations (HCT)) c) Relapse after achievement of CR or PR d) Death due to any cause.
Detailed description
Response rates according to Lugano classification PET-based, Response rate assessed by Deauville criteria, Duration Of Response (DOR), CR rate and ORR according to Lugano 2014 criteria (PET-based), subgroup analyses of mPFS, ORR, DOR, OS by PTCL subtype based on previous treatment lines, rate of patients proceeding to allogenic stem cell transplantation
Interventions
Sponsors
LYSARC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Response rates according to Lugano classification PET-based, Response rate assessed by Deauville criteria, Duration Of Response (DOR), CR rate and ORR according to Lugano 2014 criteria (PET-based), subgroup analyses of mPFS, ORR, DOR, OS by PTCL subtype based on previous treatment lines, rate of patients proceeding to allogenic stem cell transplantation | — |
Primary
| Measure | Time frame |
|---|---|
| modified PFS (mPFS), defined as time from randomization until one of the following events occurs, whichever comes first: a) Disease progression (PD) b) Administration of any additional unplanned anti-lymphoma treatment (except allogeneic or autologous hematopoietic cell transplantations (HCT)) c) Relapse after achievement of CR or PR d) Death due to any cause. | — |
Countries
Belgium, France, Germany, Spain
Outcome results
None listed