Clinical trial · Observational
Chimeric Antigen Receptor T-cell and Cellular Therapies for the Treatment of cAncer or BLood Diseases: Evaluation of Reporting of Adverse Events
NCT04279470CI-TRIAL-00065597CARTABLEcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adverse Drug Reactions | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR T-cell and Cellular Therapies | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adverse Events with cellular therapies
- description
- 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
- interventionNames
- Drug: CAR T-cell and Cellular Therapies
Primary outcomes (1)
- measure
- Number of patients with adverse events with significant over-reporting CAR-T cells and other cellular therapies
- timeFrame
- Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
- description
- Identification and report of various toxicities of cellular therapies.
Secondary outcomes (6)
- measure
- Causality assessment of reported adverse events according to the WHO system
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDolladille 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 34057232