NCT04279470

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100,000 (actual)
• Sponsor: Groupe Hospitalier Pitie-Salpetriere · Academic / Other
• Sex: All
• Age: 100 Years
• Healthy volunteers: Not accepted

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

Conditions

• Adverse Drug Reactions
• Cancer

Interventions

Type	Name	Description
DRUG	CAR T-cell and Cellular Therapies	Chimeric Antigen Receptor T-cell and Cellular Therapies for the treatment of a cancer either solid or hematologic malignancy

Timeline

• Start date: 2019-01-01
• Primary completion: 2023-01-01
• Completion: 2023-04-08
• First posted: 2020-02-21
• Last updated: 2023-04-13

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study