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

NCT ID: NCT04158011

Last Updated: 2019-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-06
• Study Completion Date: 2021-01-01

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.

Conditions

Acute Lymphoblastic Leukemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

CNS ALL at lymphodepletion

Patients with active CNS leukemia at the time of lymphodepletion

No interventions assigned to this group

CNS ALL at inclusion

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

No interventions assigned to this group

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Elad Jacoby, MD

Head, Pediatric Cancer Immunotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chaim Sheba Medical Center

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

SMC 6257-19

Identifier Type: -

Identifier Source: org_study_id