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

Groupe Hospitalier Pitie-Salpetriere

Status: Completed

Conditions: Cancer; Adverse Drug Reactions

Treatments: Drug: CAR T-cell and Cellular Therapies

Study type: Observational

Funder types: Other

Identifiers

NCT04279470

CIC1421-20-01

Details and patient eligibility

About

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).

Full 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

Enrollment: 100,000 patients

Sex: All

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

100,000 participants in 1 patient group

Adverse Events with cellular therapies

Description:

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

Treatment:

Drug: CAR T-cell and Cellular Therapies