CAR-T Long Term Follow Up (LTFU) Study
Recruiting
Phase 3
Interventional Study
Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 0 – 100
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 1,400 (estimated)
- Sponsor
- Novartis Pharmaceuticals · Industry
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About This Trial
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), mo…
Trial Locations
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Eligibility 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-d…
Contacts
Novartis Pharmaceuticals
1-888-669-6682
CONTACT
Novartis Pharmaceuticals
+41613241111
CONTACT