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

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).

Study Overview

• Status: Completed
• Conditions: Cancer; Adverse Drug Reactions
• Intervention / Treatment: Drug: CAR T-cell and Cellular Therapies

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 100000

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Hôpital Pitié-Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with cellular therapy for solid or hematologic cancer

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Pitie-Salpetriere

Publications and helpful links

General Publications

• Talavera GA, Castaneda SF, Mendoza PM, Lopez-Gurrola M, Roesch S, Pichardo MS, Garcia ML, Munoz F, Gallo LC. Latinos understanding the need for adherence in diabetes (LUNA-D): a randomized controlled trial of an integrated team-based care intervention among Latinos with diabetes. Transl Behav Med. 2021 Sep 15;11(9):1665-1675. doi: 10.1093/tbm/ibab052.
• Castaneda SF, Gallo LC, Garcia ML, Mendoza PM, Gutierrez AP, Lopez-Gurolla M, Roesch S, Pichardo MS, Munoz F, Talavera GA. Effectiveness of an integrated primary care intervention in improving psychosocial outcomes among Latino adults with diabetes: the LUNA-D study. Transl Behav Med. 2022 Aug 17;12(8):825-833. doi: 10.1093/tbm/ibac042. Erratum In: Transl Behav Med. 2023 Feb 28;13(2):120.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): April 8, 2023

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: CAR-T cell; Cellular Therapies
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Hematologic Diseases; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: CIC1421-20-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No