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

Overview

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.

Full Title of Study: “CARs for CNS-Leukemia Relapse: A Retrospective International Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: March 1, 2020

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Overall survival
    • Time Frame: 6 months
    • Duration between CAR T-cell infusion and death or last follow-up, according to Kaplan-Meier analysis

Secondary Measures

  • Incidence of CAR-related CRS or ICANS per ASCTC guidelines
    • Time Frame: 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
    • Time Frame: 6 months
    • Duration between CAR T-cell infusion and leukemia relapse, according to Kaplan-Meier analysis
  • CNS-leukemia free survival
    • Time Frame: 6 months
    • Duration between CAR T-cell infusion and CNS leukemia relapse, according to Kaplan-Meier analysis

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sheba Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Elad Jacoby, MD, Head, Pediatric Cancer Immunotherapy – Sheba Medical Center

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