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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05040230
Other study ID # RECHMPL21_0287
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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