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Набира участници Фаза 3 NCT02445222

CAR-T Long Term Follow Up (LTFU) Study

Фаза 3 – широко изпитване преди одобрение
Заболявания: Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program

Спонсор: Novartis Pharmaceuticals

Налично на: БГ
Обобщение
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.
Описание
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.
Кой може да участва
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.
Места на провеждане 21
Австралия (1)
Novartis Investigative Site
Camperdown , New South Wales
Белгия (1)
Novartis Investigative Site
Ghent
Канада (1)
Novartis Investigative Site
Hamilton , Ontario
Китай (1)
Novartis Investigative Site
Beijing
Дания (1)
Novartis Investigative Site
Copenhagen
Финландия (1)
Novartis Investigative Site
Helsinki
Франция (1)
Novartis Investigative Site
Nantes
Гърция (1)
Novartis Investigative Site
Chaïdári
Hong Kong (1)
Novartis Investigative Site
Hong Kong
Израел (1)
Novartis Investigative Site
Ramat Gan
Италия (1)
Novartis Investigative Site
Bologna , BO
Япония (1)
Novartis Investigative Site
Fukuoka , Fukuoka
Нидерландия (1)
Novartis Investigative Site
Amsterdam , North Holland
COMPLETED
Норвегия (1)
Novartis Investigative Site
Oslo
Saudi Arabia (1)
Novartis Investigative Site
Riyadh
Сингапур (1)
Novartis Investigative Site
Singapore
Южна Корея (1)
Novartis Investigative Site
Seoul
Испания (1)
Novartis Investigative Site
Esplugues , Barcelona
Taiwan (1)
Novartis Investigative Site
Taipei
Великобритания (1)
Novartis Investigative Site
Birmingham
САЩ (1)
Mayo Clinic Arizona
Phoenix , Arizona
COMPLETED
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
0 Years
Максимална възраст
100 Years
Здрави доброволци
Не
Начална дата
02.11.2015
Крайна дата
22.02.2036
Регистрационен номер
NCT02445222
Източник
anzctr
Запитване за медицински туризъм

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