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This is a single arm, open-label, multi-center, phase II study to determine the activity and the safety of a therapeutic strategy that allows a second CARCIK-CD19 cells infusion, driven by the status of disease from one month after the first infusion, in adult and pediatric patients with r/r BCP- ALL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CARCIK-CD19 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTG-CARCIK-CD19 | Genetic | PTG-CARCIK-CD19 cells is a gene therapy medicinal product (GTMP) composed of genetically modified allogeneic T lymphocytes formulated as cell suspension in normal saline solution and freezing media |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion | At baseline and at Day 28 after infusion: lymphoblasts < 5% at morphological evaluation of bone marrow aspirate | Baseline and day 28 |
| To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion | At baseline and at Day 28 after infusion: lymphoblasts < 5% at flow cytometry bone marrow evaluation | Baseline and day 28 |
| To evaluate the overall response rate: change from baseline at day 28 after the first CARCIK-CD19 infusion | At baseline and at Day 28 after infusion: molecular evaluation of disease positivity <0.01% | Baseline and day 28 |
| To evaluate the duration of response of patients treated with CARCIK - CD19 cells. Change from day 28 at month 2, 3, 4, 5, 6, 9 and 12 | Day 28 and month 2, 3, 4, 5, 6, 9 and 12: lymphoblasts < 5% at morphological evaluation of bone marrow aspirate | Day 28 and month 2, 3, 4, 5, 6, 9 and 12 |
| To evaluate the duration of response of patients treated with CARCIK - CD19 cells. Change from day 28 at month 2, 3, 4, 5, 6, 9 and 12 | Day 28 and month 2, 3, 4, 5, 6, 9 and 12: lymphoblasts < 5% at flow cytometry bone marrow evaluation | Day 28 and month 2, 3, 4, 5, 6, 9 and 12 |
| To evaluate the duration of response of patients treated with CARCIK - CD19 cells. Change from day 28 at month 2, 3, 4, 5, 6, 9 and 12 | Day 28 and month 2, 3, 4, 5, 6, 9 and 12: molecular evaluation of disease positivity <0.01% |
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Inclusion Criteria:
Children (1-17) and adults (18-75 years old);
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale PG23 | Recruiting | Bergamo | Italy |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Day 28 and month 2, 3, 4, 5, 6, 9 and 12 |
| Fondazione MBBM | Recruiting | Monza | Italy |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |