CAR-T Long Term Follow Up (LTFU) Study
About the study
Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- All patients who have received a CAR-T therapy and completed or discontinued early from a Novartis sponsored treatment protocol that utilized CAR-T cells or from any CAR-T trial sponsored by the University of Pennsylvania with which Novartis has a contractual agreement to co-develop the CAR technology.
- Patients who have provided informed consent for the long term follow up study prior to their study participation .
EXCLUSION CRITERIA
Exclusion Criteria:
There are no specific exclusion criteria for this study.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
Phase
Not Applicable
Participants needed
1400
Est. Completion Date
Feb 22, 2036
Treatment type
Interventional
Sponsor
Novartis
ClinicalTrials.gov identifier
NCT02445222
Study number
CCTL019A2205B
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