Chimeric Antigen Receptor T-cell and Cellular Therapies for the Treatment of cAncer or BLood Diseases: Evaluation of Reporting of Adverse Events
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100,000
- Locations
- 1
- Primary Endpoint
- Number of patients with adverse events with significant over-reporting CAR-T cells and other cellular therapies
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- — to 100 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Adverse Events with 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
Intervention: CAR T-cell and Cellular Therapies (Drug)
Outcomes
Primary Outcomes
Number of patients with adverse events with significant over-reporting CAR-T cells and other cellular therapies
Time Frame: 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 Outcomes
- 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)
Investigators
Joe Elie Salem
Principal Investigator
Groupe Hospitalier Pitie-Salpetriere