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

Cancer Clinical Trial

— CARTABLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04279470
• Other study ID #: CIC1421-20-01
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: April 8, 2023

Study information

• Verified date: April 2023
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100000
• Est. completion date: April 8, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Adverse Drug Reactions
• Cancer
• Drug-Related Side Effects and Adverse Reactions
• Hematologic Diseases

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

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