A Retrospective Study of Patients With Leukemia Relapse in the CNS Treated With CAR T Cells

Sheba Medical Center

Status: Unknown

Conditions: Acute Lymphoblastic Leukemia

Study type: Observational

Funder types: Other

Identifiers

NCT04158011

SMC 6257-19

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

80 participants in 2 patient groups

CNS ALL at lymphodepletion

Description:

Patients with active CNS leukemia at the time of lymphodepletion

CNS ALL at inclusion

Description:

Patients who were referred to CAR T-cells with CNS disease, which was cleared by the time of lymphodepletion