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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Adverse Drug Reactions, Cancer

Intervention / Treatment
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* Drug: CAR T-cell and Cellular Therapies


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adverse Events with cellular therapies<br>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 | Drug: CAR T-cell and Cellular Therapies<br>* Chimeric Antigen Receptor T-cell and Cellular Therapies for the treatment of a cancer either solid or hematologic malignancy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAR-T cell, Cellular Therapies