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

Sponsor
Sheba Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT04158011
Collaborator
(none)
80
Enrollment
1
Location
13.9
Anticipated Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    CARs for CNS-Leukemia Relapse: A Retrospective International Study
    Actual Study Start Date :
    Nov 6, 2019
    Anticipated Primary Completion Date :
    Mar 1, 2020
    Anticipated Study Completion Date :
    Jan 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [6 months]

      Duration between CAR T-cell infusion and death or last follow-up, according to Kaplan-Meier analysis

    Secondary Outcome Measures

    1. 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)

    2. Leukemia-free survival [6 months]

      Duration between CAR T-cell infusion and leukemia relapse, according to Kaplan-Meier analysis

    3. CNS-leukemia free survival [6 months]

      Duration between CAR T-cell infusion and CNS leukemia relapse, according to Kaplan-Meier analysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chaim Sheba Medical Center Ramat Gan Israel

    Sponsors and Collaborators

    • Sheba Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elad Jacoby, MD, Head, Pediatric Cancer Immunotherapy, Sheba Medical Center
    ClinicalTrials.gov Identifier:
    NCT04158011
    Other Study ID Numbers:
    • SMC 6257-19
    First Posted:
    Nov 8, 2019
    Last Update Posted:
    Nov 8, 2019
    Last Verified:
    Nov 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Elad Jacoby, MD, Head, Pediatric Cancer Immunotherapy, Sheba Medical Center
    CAR T cells
    CNS leukemia
    Additional relevant MeSH terms:
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma

    Study Results

    No Results Posted as of Nov 8, 2019