Clinical trial NCT05040230: EEG Encephalopathy Patterns in Immune Effectors Cells-associated Neurotoxicity Syndrome (ICANS)Lay Language
Official title: EEG Encephalopathy Patterns in Immune Effectors Cells-associated Neurotoxicity Syndrome : a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immune Effector Cell Encephalopathy
Neurotoxicity
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: a prospective cohort study of all patients who received CAR T cell infusions on the hematology department from Montpellier University Medical Center between September 2020 and July 2021

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: to assess the sensitivity of EEG for diagnosis of ICANS.
timeFrame: day 1
Secondary outcomes:
measure: to identify a biomarker for ICANS
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Xavier Ayrignac, MD
role: STUDY_DIRECTOR
References: