NCT04279470

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

4 years

First QC Date

February 19, 2020

Last Update Submit

April 12, 2023

Conditions

Adverse Drug ReactionsCancer

Keywords

CAR-T cellCellular Therapies

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

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

Interventions

CAR T-cell and Cellular TherapiesDRUG

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

Adverse Events with cellular therapies

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with cellular therapy for solid or hematologic cancer

You may qualify if:

  • 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.

You may not qualify if:

  • Chronology not compatible between the drug and the toxicity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

Related Publications (1)

  • 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.

    PMID: 34057232DERIVED

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsNeoplasms

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2020

First Posted

February 21, 2020

Study Start

January 1, 2019

Primary Completion

January 1, 2023

Study Completion

April 8, 2023

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)