Chimeric Antigen Receptor T-cell and Cellular Therapies for the Treatment of cAncer or BLood Diseases: Evaluation of Reporting of Adverse Events

Completed

• Conditions: Adverse Drug Reactions; Cancer
• Interventions: Drug: CAR T-cell and Cellular Therapies

• Registration Number: NCT04279470
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

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

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-21
• Primary Completion: 2023-01-01
• Status Verified: 2023-04
• Study Completion: 2023-04-08
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adverse Events with cellular therapies	CAR T-cell and Cellular Therapies	Cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of patients treated by Chimeric Antigen Receptor T-cell and Cellular Therapies, with a chronology compatible with the drug toxicity

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events with significant over-reporting CAR-T cells and other cellular therapies	Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020	Identification and report of various toxicities of cellular therapies.

Secondary Outcome Measures

Name	Time	Method
Description of the type of adverse event depending on the class and the target of cellular therapy	Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
Causality assessment of reported adverse events according to the WHO system	Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
Description of the drug-drug interactions associated with adverse events	Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed	Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
Description of the population of patients having an adverse event	Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
Description of the duration of treatment when the toxicity happens and the time to onset	Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020

Trial Locations

Locations (1)

Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France