An observational study in Adverse Drug Reactions and Cancer, sponsored by Groupe Hospitalier Pitie-Salpetriere. Completed at 1 site in France. Open to participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2023-04-13.
Sponsored by Groupe Hospitalier Pitie-Salpetriere · Observational
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).
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
460 studies on the registry are indexed under Hematologic Diseases; 105 are open to participants now.
This study's enrollment of 100,000 is above the median of 228 across 129 observational studies indexed under Hematologic Diseases.
Browse Hematologic Diseases studies →Groupe Hospitalier Pitie-Salpetriere is the lead sponsor of 65 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated with cellular therapy for solid or hematologic cancer
Exclusion Criteria:
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
Chimeric Antigen Receptor T-cell and Cellular Therapies for the treatment of a cancer either solid or hematologic malignancy
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
Plan to share: No
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Groupe Hospitalier Pitie-Salpetriere