Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04279470
Recruitment Status : Active, not recruiting
First Posted : February 21, 2020
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere

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).

Condition or disease Intervention/treatment
Adverse Drug Reactions Cancer 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

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100000 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Chimeric Antigen Receptor T-cell and Cellular Therapies for the Treatment of cAncer or BLood Diseases: Evaluation of Reporting of Adverse Events
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Disorders

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with cellular therapy for solid or hematologic cancer
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04279470


Locations
Layout table for location information
France
Hôpital Pitié-Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere

Layout table for additonal information
Responsible Party: Joe Elie Salem, Principal Investigator, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT04279470    
Other Study ID Numbers: CIC1421-20-01
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere:
CAR-T cell
Cellular Therapies
Additional relevant MeSH terms:
Layout table for MeSH terms
Hematologic Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders