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Completed

NCT Number: NCT04279470

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

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).

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Key information

Conditions

Adverse Drug Reactions Cancer Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Neoplasms

Age range

Up to 100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Pitié-Salpêtrière

Paris, 75013, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAR T-cell and Cellular Therapies

Drug

Chimeric Antigen Receptor T-cell and Cellular Therapies for the treatment of a cancer either solid or hematologic malignancy

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Registry information

Acronym: CARTABLE

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2020
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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