Relapsed/refractory B-cell Acute Lymphoblastic Leukemia
Conditions
Brief summary
To evaluate the safety of the infusion of CD19-CAR_Lenti_ALLO evaluating 2 dose levels (DLs) for each cohort of patients, depending on the donor HLA-matching (for fully matched, familial or unrelated donor, DL1: 3.0 x 106; DL2: 5.0 x 106 cells/kg recipient total body weight of CAR+ T cells; for haploidentical donor, DL1: 1.0 x 106; DL2: 3.0 x 106 cells/kg recipient total body weight of CAR+ T cells) and establish the dose-limiting toxicity (DLT) of the cellular product. DLT will be defined as an
Detailed description
1. To estimate the rate of occurrence and the severity of acute and/or chronic GvHD 2. To evaluate the proportion of patients achieving either CR or CR with incomplete blood count recovery (CRi) and MRD negativity by either flow-cytometry or qPCR at day 28 (defined as a value < 1x10-4 ). 3. To estimate the probability of obtaining CR with MRD negativity stratified according to the disease burden at time of enrollment
Interventions
Sponsors
Ospedale Pediatrico Bambino Gesu'
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety of the infusion of CD19-CAR_Lenti_ALLO evaluating 2 dose levels (DLs) for each cohort of patients, depending on the donor HLA-matching (for fully matched, familial or unrelated donor, DL1: 3.0 x 106; DL2: 5.0 x 106 cells/kg recipient total body weight of CAR+ T cells; for haploidentical donor, DL1: 1.0 x 106; DL2: 3.0 x 106 cells/kg recipient total body weight of CAR+ T cells) and establish the dose-limiting toxicity (DLT) of the cellular product. DLT will be defined as an | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To estimate the rate of occurrence and the severity of acute and/or chronic GvHD 2. To evaluate the proportion of patients achieving either CR or CR with incomplete blood count recovery (CRi) and MRD negativity by either flow-cytometry or qPCR at day 28 (defined as a value < 1x10-4 ). 3. To estimate the probability of obtaining CR with MRD negativity stratified according to the disease burden at time of enrollment | — |
Countries
Italy
Outcome results
None listed