Clinical trial NCT04279470: Chimeric Antigen Receptor T-cell and Cellular Therapies for the Treatment of cAncer or BLood Diseases: Evaluation of Reporting of Adverse Events
Official title: Chimeric Antigen Receptor T-cell and Cellular Therapies for the Treatment of cAncer or BLood Diseases: Evaluation of Reporting of Adverse Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Drug Reactions
Cancer
Keywords: CAR-T cell
Cellular Therapies
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 100000
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with cellular therapy for solid or hematologic cancer

Brief summary: CAR-T cells and cellular therapies may lead to various adverse reactions. This study investigates reports of different toxicities for cellular therapies in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

Detailed description: CAR-T cells and cellular therapies are responsible of a wide range of side effects.The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of adverse drug reactions following treatment with cellular therapies

Eligibility criteria: Inclusion Criteria:

* Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2020
* Adverse events reported were including any MedDRA terms
* Patients treated with cellular therapies reported in the WHO database.

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity

Primary outcomes:
measure: Number of patients with adverse events with significant over-reporting CAR-T cells and other cellular therapies
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
Secondary outcomes:
measure: Causality assessment of reported adverse events according to the WHO system
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
measure: Description of the type of adverse event depending on the class and the target of cellular therapy
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
measure: Description of the duration of treatment when the toxicity happens and the time to onset
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
measure: Description of the drug-drug interactions associated with adverse events
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
measure: Description of the pathologies (cancer) for which the incriminated drugs have been prescribed
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
measure: Description of the population of patients having an adverse event
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
Study officials:
References:
citation: Dolladille C, Ederhy S, Ezine E, Choquet S, Nguyen LS, Alexandre J, Moslehi JJ, Dechartres A, Salem JE. Chimeric antigen receptor T-cells safety: A pharmacovigilance and meta-analysis study. Am J Hematol. 2021 Sep 1;96(9):1101-1111. doi: 10.1002/ajh.26259. Epub 2021 Jun 23.