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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2023-04-08

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

Conditions

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Adverse Drug Reactions Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type DRUG

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

Intervention Type DRUG

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
Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role lead

Responsible Party

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Joe Elie Salem

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hôpital Pitié-Salpêtrière

Paris, , France

Site Status

Countries

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France

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.

Reference Type DERIVED
PMID: 34057232 (View on PubMed)

Other Identifiers

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CIC1421-20-01

Identifier Type: -

Identifier Source: org_study_id

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