Clinical trial

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

Name

CIC1421-20-01

Description

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).

Trial arms

Trial start

2019-01-01

Estimated PCD

2023-01-01

Trial end

2023-04-08

Status

Completed

Treatment

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

Arms:

Adverse Events with cellular therapies

Size

100000

Primary endpoint

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

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'count': 100000, 'type': 'ACTUAL'}}

Updated at

2023-04-13

1 organization

1 product

2 indications

Organization

Groupe Hospitalier Pitie-Salpetriere

Product

CAR T-cell and Cellular Therapies

Indication

adverse drug reactions

Indication

Cancer