Adverse Drug ReactionsCARTABLENCT04279470
Chimeric Antigen Receptor T-cell and Cellular Therapies for the Treatment of cAncer or BLood Diseases: Evaluation of Reporting of Adverse Events
An observational study of Adverse Drug Reactions and Cancer, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Adverse Drug Reactions, Cancer
- What is being tested?
- CAR T-cell and Cellular Therapies
- How many people
- 100,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 8 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated with cellular therapy for solid or hematologic cancer
Who may be able to join
- 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.
Who cannot join
- Chronology not compatible between the drug and the toxicity
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- Conditions
- Adverse Drug Reactions, Cancer
- Being tested
- CAR T-cell and Cellular Therapies
- Keywords
- CAR-T cell, Cellular Therapies
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: CAR T-cell and Cellular Therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start1 Jan 2019
- Primary completion1 Jan 2023
- Study completion8 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adverse Drug ReactionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279470
- Sponsor's protocol ID
- CIC1421-20-01
- Acronym
- CARTABLE
- Status last verified
- Apr 2023
- First submitted
- 19 Feb 2020
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34057232
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chimeric Antigen Receptor T-cell and Cellular Therapies for the Treatment of cAncer or BLood Diseases: Evaluation of Reporting of Adverse Events
- ClinicalTrials.gov ID
- NCT04279470
- Acronym / sponsor ID
- CARTABLE / CIC1421-20-01
- Conditions
- Adverse Drug Reactions, Cancer
- Keywords
- CAR-T cell, Cellular Therapies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100,000 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 8 Apr 2023 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adverse Events with cellular therapies | – | Drug: CAR T-cell and Cellular TherapiesCases 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 |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with cellular therapy for solid or hematologic cancer
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Chronology not compatible between the drug and the toxicity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAR T-cell and Cellular TherapiesChimeric Antigen Receptor T-cell and Cellular Therapies for the treatment of a cancer either solid or hematologic malignancy | Drug | Adverse Events with cellular therapies |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Derived from this study: PubMed 34057232Dolladille 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Drug Reactions and Cancer, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04279470, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.