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

NCT05040230 | Completed

• 1 other identifier: RECHMPL21_0287
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Effector Cell Encephalopathy; Neurotoxicity

Outcome Measures

Primary Outcomes (1)

• to assess the sensitivity of EEG for diagnosis of ICANS.

  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

  day 1

Secondary Outcomes (1)

• to identify a biomarker for ICANS

  day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• histologically confirmed: diffuse large B-cell lymphoma, B-cell acute lymphoblastic leukemia, follicular lymphoma, or mantle cell lymphoma.
• with infusion of CAR T-cells

You may not qualify if:

• \- Age \< 18 years

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Neurotoxicity Syndromes

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Xavier Ayrignac, MD

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: September 10, 2021
• Study Start: February 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 30, 2021
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

FR (1)