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CAR T cells targeting CD19 have been approved for patients with relapsed or refractory ALL, failing two or more prior protocols. Several institutional-based studies with other CAR T cells targeting CD19 have demonstrated outstanding response rates in patients with refractory disease, and the ability of CAR T cells to clear CNS leukemia. Nevertheless, these cases are sparse and have never been reported collectively.
Here, we aim to retrospectively assess toxicity and long term outcome of patients treated with CAR T cells for CNS relapse of ALL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CNS ALL at lymphodepletion | Patients with active CNS leukemia at the time of lymphodepletion | ||
| CNS ALL at inclusion | Patients who were referred to CAR T-cells with CNS disease, which was cleared by the time of lymphodepletion |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Duration between CAR T-cell infusion and death or last follow-up, according to Kaplan-Meier analysis | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of CAR-related CRS or ICANS per ASCTC guidelines | Number of patients and average grade of cytokine-release syndrome and immune-effector cell associated neurotoxicity syndrome within 2 months after CAR treatment, according to ASCTC guidelines (Lee et al, BBMT 2019) | 2 months |
| Leukemia-free survival |
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Inclusion Criteria:
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Retrospective review of patients with CNS - involvement of B-cell ALL, treated with CAR T cells targeting CD19 of either an institutional-based clinical trial, a pharma-based clinical trial or commercial product.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chaim Sheba Medical Center | Ramat Gan | Israel |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 4, 2022 | |
| Reset | Feb 1, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 4, 2022 | Feb 1, 2023 |
| 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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Duration between CAR T-cell infusion and leukemia relapse, according to Kaplan-Meier analysis |
| 6 months |
| CNS-leukemia free survival | Duration between CAR T-cell infusion and CNS leukemia relapse, according to Kaplan-Meier analysis | 6 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |