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

Neurotoxicity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05040230
• Other study ID #: RECHMPL21_0287
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 30, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Neurotoxicity
• Neurotoxicity Syndromes

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to assess the sensitivity of EEG for diagnosis of ICANS.	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	day 1
Secondary	to identify a biomarker for ICANS	to identify a biomarker for ICANS	day 1