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Recruiting Phase 3 NCT02445222

CAR-T Long Term Follow Up (LTFU) Study

Phase 3 – large-scale trial before approval
Conditions: Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program

Sponsor: Novartis Pharmaceuticals

trial.available_in: БГ
Overview
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.
Description
Patients are enrolled following completion or early discontinuation from a Novartis sponsored or supported study of CAR T-Cell treatment. Patients will be followed for 15 years post treatment from the last treatment. They will be monitored for safety and efficacy within the primary treatment protocols for the protocol defined duration. Patients can drop off treatment protocols at any time to enter this long term Follow up study. Patients discontinuing from the primary treatment protocols for any reason will be enrolled in this long term follow up (LTFU). This will allow collecting data on long term safety and efficacy (as applicable) as mandated by the health authorities of all patients treated with CAR-T therapy within the concept of a single protocol. Collection of such long term effects of CAR-T cell therapy will help to further define the risk-benefit profile of CAR-T Therapies.
Who can participate
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: * There are no specific exclusion criteria for this study.
Locations 21
Australia (1)
Novartis Investigative Site
Camperdown , New South Wales
Belgium (1)
Novartis Investigative Site
Ghent
Canada (1)
Novartis Investigative Site
Hamilton , Ontario
China (1)
Novartis Investigative Site
Beijing
Denmark (1)
Novartis Investigative Site
Copenhagen
Finland (1)
Novartis Investigative Site
Helsinki
France (1)
Novartis Investigative Site
Nantes
Greece (1)
Novartis Investigative Site
Chaïdári
Hong Kong (1)
Novartis Investigative Site
Hong Kong
Israel (1)
Novartis Investigative Site
Ramat Gan
Italy (1)
Novartis Investigative Site
Bologna , BO
Japan (1)
Novartis Investigative Site
Fukuoka , Fukuoka
Netherlands (1)
Novartis Investigative Site
Amsterdam , North Holland
COMPLETED
Norway (1)
Novartis Investigative Site
Oslo
Saudi Arabia (1)
Novartis Investigative Site
Riyadh
Singapore (1)
Novartis Investigative Site
Singapore
South Korea (1)
Novartis Investigative Site
Seoul
Spain (1)
Novartis Investigative Site
Esplugues , Barcelona
Taiwan (1)
Novartis Investigative Site
Taipei
United Kingdom (1)
Novartis Investigative Site
Birmingham
United States (1)
Mayo Clinic Arizona
Phoenix , Arizona
COMPLETED
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
0 Years
Maximum age
100 Years
Healthy volunteers
No
Start date
02.11.2015
Completion date
22.02.2036
Registry ID
NCT02445222
Source
anzctr
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