Chimeric Antigen Receptor T-cell and Cellular Therapies for the Treatment of cAncer or BLood Diseases: Evaluation of Reporting of Adverse Events
NCT ID: NCT04279470
Last Updated: 2023-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100000 participants
OBSERVATIONAL
2019-01-01
2023-04-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Adverse events reported were including any MedDRA terms
* Patients treated with cellular therapies reported in the WHO database.
Exclusion Criteria
100 Years
ALL
No
Sponsors
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Groupe Hospitalier Pitie-Salpetriere
OTHER
Responsible Party
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Joe Elie Salem
Principal Investigator
Locations
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Hôpital Pitié-Salpêtrière
Paris, , France
Countries
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References
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Dolladille C, Ederhy S, Ezine E, Choquet S, Nguyen LS, Alexandre J, Moslehi JJ, Dechartres A, Salem JE. Chimeric antigen receptor T-cells safety: A pharmacovigilance and meta-analysis study. Am J Hematol. 2021 Sep 1;96(9):1101-1111. doi: 10.1002/ajh.26259. Epub 2021 Jun 23.
Other Identifiers
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CIC1421-20-01
Identifier Type: -
Identifier Source: org_study_id
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