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

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.

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Key information

Conditions

Immune Effector Cell Encephalopathy Chemically-Induced Disorders Nervous System Diseases Neurotoxicity Neurotoxicity Syndromes Poisoning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

to assess the sensitivity of EEG for diagnosis of ICANS.

Time frame: 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 outcomes

to identify a biomarker for ICANS

Time frame: day 1

to identify a biomarker for ICANS

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

EEG Encephalopathy Patterns in Immune Effectors Cells-associated Neurotoxicity Syndrome : a Prospective Observational Study

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Sep 10, 2021
Registry last updated: Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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