RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMAS
Conditions
Brief summary
Phase 1: maximum tolerated dose (MTD) and the recommended phase II dose. Assessment of the MTD will be performed by the analysis of the dose-limiting toxicities (DLTs)., Phase 2: Modified Progression-Free Survival (mPFS), defined as time from first dose of sub-study treatment until one of the following events occurs, whichever comes first: a) Disease progression (PD) b) Relapse after achievement of CR or PR c) Administration of any additional unplanned anti-lymphoma treatment (except allogeneic or autologous hematopoietic cell transplantations used as consolidation treatment) d) Death due to any cause.
Detailed description
- Objective response rate (ORR), - Complete response rate (CRR), - Clinical benefit rate (CBR), - Best Objective response (BOR), - Progression free survival (PFS), - Lymphoma specific survival (LSS), - Duration of Response (DoR), - Time to next treatment or death (TNT-D), - Overall Survival (OS), - Rate of transplantation following treatment, - Time to transplantation, - Safety
Interventions
Sponsors
LYSARC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: maximum tolerated dose (MTD) and the recommended phase II dose. Assessment of the MTD will be performed by the analysis of the dose-limiting toxicities (DLTs)., Phase 2: Modified Progression-Free Survival (mPFS), defined as time from first dose of sub-study treatment until one of the following events occurs, whichever comes first: a) Disease progression (PD) b) Relapse after achievement of CR or PR c) Administration of any additional unplanned anti-lymphoma treatment (except allogeneic or autologous hematopoietic cell transplantations used as consolidation treatment) d) Death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Objective response rate (ORR), - Complete response rate (CRR), - Clinical benefit rate (CBR), - Best Objective response (BOR), - Progression free survival (PFS), - Lymphoma specific survival (LSS), - Duration of Response (DoR), - Time to next treatment or death (TNT-D), - Overall Survival (OS), - Rate of transplantation following treatment, - Time to transplantation, - Safety | — |
Countries
France
Outcome results
None listed