Relapsed/refractory CD19+ Acute Lymphoblastic Leukemia and Diffuse Large B Cell Lymphoma or Primary Mediastinal B Cell Lymphoma
Conditions
Brief summary
PHASE I The safety and tolerability of CD19-CAR_Lenti will be assessed by: - Suspected adverse events, and - Suspected serious adverse events As evidenced by clinically relevant: - Changes in clinical laboratory tests (clinical chemistry, hematology, etc). - Changes in vital signs (blood pressure, pulse, respiratory rate and body temperature). - Changes in physical examination. Signs and symptoms assessed may require additional testing as clinically indicated such as ECG, PFT, radiographic studi
Detailed description
Secondary Endpoints phase I and II Relapse rate (RR), overall survival (OS), and disease-free survival (DFS) will be evaluated at 1 and 2 years. - The expansion and persistence of CD19-CAR_Lenti will be measured by flow cytometry and qPCR. - The T cell subpopulations of the CD19-CAR_Lenti cells before and after infusion and the exhaustion profile will be measured by flow cytometry - Disease outcome will be correlated with: a) use of either steroids and/or tocilizumab for CRS/Neurotoxicity; b) pr
Interventions
Sponsors
Ospedale Pediatrico Bambino Gesu
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PHASE I The safety and tolerability of CD19-CAR_Lenti will be assessed by: - Suspected adverse events, and - Suspected serious adverse events As evidenced by clinically relevant: - Changes in clinical laboratory tests (clinical chemistry, hematology, etc). - Changes in vital signs (blood pressure, pulse, respiratory rate and body temperature). - Changes in physical examination. Signs and symptoms assessed may require additional testing as clinically indicated such as ECG, PFT, radiographic studi | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints phase I and II Relapse rate (RR), overall survival (OS), and disease-free survival (DFS) will be evaluated at 1 and 2 years. - The expansion and persistence of CD19-CAR_Lenti will be measured by flow cytometry and qPCR. - The T cell subpopulations of the CD19-CAR_Lenti cells before and after infusion and the exhaustion profile will be measured by flow cytometry - Disease outcome will be correlated with: a) use of either steroids and/or tocilizumab for CRS/Neurotoxicity; b) pr | — |
Countries
Italy
Outcome results
None listed