relapsed or refractory patients with aggressive large B-cell lymphoma at high risk of relapse
Conditions
Brief summary
Efficacy determination will be based upon the primary endpoint of complete metabolic response (CMR) rate at 3 months after infusion of anti-CD19 CAR T-cell assessed by study investigator.
Detailed description
Objective response rate (ORR), Complete metabolic response (CMR), Partial metabolic response (PMR), Duration of response (DoR), Event-free survival (EFS), Progression-free survival (PFS), Time to next anti-lymphoma therapy (TTNLT), Overall survival (OS)
Interventions
Sponsors
Lymphoma Academic Research Organisation
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy determination will be based upon the primary endpoint of complete metabolic response (CMR) rate at 3 months after infusion of anti-CD19 CAR T-cell assessed by study investigator. | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR), Complete metabolic response (CMR), Partial metabolic response (PMR), Duration of response (DoR), Event-free survival (EFS), Progression-free survival (PFS), Time to next anti-lymphoma therapy (TTNLT), Overall survival (OS) | — |
Countries
France
Outcome results
None listed