- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04279470
Chimeric Antigen Receptor T-cell and Cellular Therapies for the Treatment of cAncer or BLood Diseases: Evaluation of Reporting of Adverse Events (CARTABLE)
April 12, 2023 updated by: Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France, 75013
- Hôpital Pitié-Salpétrière
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
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
|
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
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.
|
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
Time Frame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
|
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
|
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
|
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
|
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
|
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
|
Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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