Acute Lymphoblastic Leukemia
Conditions
Keywords
CAR T cells, CNS leukemia
Brief summary
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.
Interventions
None listed
Sponsors
Sheba Medical Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Prior diagnosis of B-cell acute lymphoblastic leukemia involving the central nervous system * Treatment with CAR T cells (either on a clinical trial or commercial use) due to this indication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 6 months | Duration between CAR T-cell infusion and death or last follow-up, according to Kaplan-Meier analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of CAR-related CRS or ICANS per ASCTC guidelines | 2 months | 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) |
| Leukemia-free survival | 6 months | Duration between CAR T-cell infusion and leukemia relapse, according to Kaplan-Meier analysis |
| CNS-leukemia free survival | 6 months | Duration between CAR T-cell infusion and CNS leukemia relapse, according to Kaplan-Meier analysis |
Countries
Israel
Outcome results
None listed