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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

Tracking Information
First Submitted Date February 19, 2020
First Posted Date February 21, 2020
Last Update Posted Date February 24, 2020
Actual Study Start Date January 1, 2019
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 20, 2020)
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.
Original Primary Outcome Measures
 (submitted: February 19, 2020)
Adverse events with 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.
Change History
Current Secondary Outcome Measures
 (submitted: February 19, 2020)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Chimeric Antigen Receptor T-cell and Cellular Therapies for the Treatment of cAncer or BLood Diseases: Evaluation of Reporting of Adverse Events
Official Title Chimeric Antigen Receptor T-cell and Cellular Therapies for the Treatment of cAncer or BLood Diseases: Evaluation of Reporting of Adverse Events
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).
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
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients treated with cellular therapy for solid or hematologic cancer
Condition
  • Adverse Drug Reactions
  • Cancer
Intervention 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
Study Groups/Cohorts 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
Intervention: Drug: CAR T-cell and Cellular Therapies
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: February 19, 2020)
100000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2025
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 100 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04279470
Other Study ID Numbers CIC1421-20-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
Study Sponsor Groupe Hospitalier Pitie-Salpetriere
Collaborators Not Provided
Investigators Not Provided
PRS Account Groupe Hospitalier Pitie-Salpetriere
Verification Date February 2020