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

Completed

• Conditions: Neurotoxicity; Immune Effector Cell Encephalopathy

• Registration Number: NCT05040230
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-09-01
• Study First Posted: 2021-09-10
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 : 1. background frequencies : alpha, theta or delta; 2. reactivity on opening the eyes : yes or not; 3. organization of background activity : present or absent; 4. presence of paroxysmal activities : yes or not

Secondary Outcome Measures

Name	Time	Method
to identify a biomarker for ICANS	day 1	to identify a biomarker for ICANS

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France