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EEG Encephalopathy Patterns in Immune Effectors Cells-associated Neurotoxicity Syndrome (ICANS)Lay Language

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT05040230
Collaborator
(none)
40
Enrollment
1
Location
10.9
Actual Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Immune effectors cells-associated neurotoxicity syndrome (ICANS) is one of the most clearly defined acute toxicities after CAR-T cells infusion.

The investigators conducted a prospective cohort study of all patients who received CAR T cell infusions on the hematology department from Montpellier University Medical Center.

Each patient was assessed between the 6th and 8th day after infusion by a neurological clinical examination, an electroencephalogram, and a brain MRI.

The aim of the studies is to describe the EEG pattern associated with ICANS.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The investigators will conduct a prospective cohort study of all patients who received CAR T cell infusions in the hematology department from Montpellier University Medical Center. To be eligible for enrollment, patients should have to be 18 years of age or older. All the patients will have histologically confirmed: diffuse large B-cell lymphoma, B-cell acute lymphoblastic leukemia, follicular lymphoma, or mantle cell lymphoma.

    Each patient will have a PET CT before infusion to determine metabolic response status according to the LUGANO grading classification. All patients will have preconditioning brain imaging by MRI.

    Each patient will be assessed between the 6th and 8th day after infusion by a neurological clinical examination, an electroencephalogram, and a brain MRI.

    Patients will be called back one month later to report any new neurological event and an EEG was performed if abnormalities were found on the first.

    All neurological symptoms documented in daily progress notes will be catalogued. The investigators will use ASTCT ICANS Consensus Grading for Adults to evaluate neurotoxicity.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    EEG Encephalopathy Patterns in Immune Effectors Cells-associated Neurotoxicity Syndrome : a Prospective Observational Study
    Actual Study Start Date :
    Feb 1, 2021
    Actual Primary Completion Date :
    Dec 1, 2021
    Actual Study Completion Date :
    Dec 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. to assess the sensitivity of EEG for diagnosis of ICANS. [day 1]

      bandwidth of the EEG which will be assessed during the period of study : background frequencies : alpha, theta or delta reactivity on opening the eyes : yes or not organization of background activity : present or absent presence of paroxysmal activities : yes or not

    Secondary Outcome Measures

    1. to identify a biomarker for ICANS [day 1]

      to identify a biomarker for ICANS

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • histologically confirmed: diffuse large B-cell lymphoma, B-cell acute lymphoblastic leukemia, follicular lymphoma, or mantle cell lymphoma.

    • with infusion of CAR T-cells

    Exclusion criteria:
    • Age < 18 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Study Director: Xavier Ayrignac, MD, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT05040230
    Other Study ID Numbers:
    • RECHMPL21_0287
    First Posted:
    Sep 10, 2021
    Last Update Posted:
    Apr 12, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Brain Diseases
    Neurotoxicity Syndromes

    Study Results

    No Results Posted as of Apr 12, 2022