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CAR-T Long Term Follow Up (LTFU) Study

RecruitingPhase 3Ages 0 Years - 100 YearsAllNovartis Pharmaceuticals
NCT02445222 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Previously treated CAR-T patients
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Where

120 sites
Mayo Clinic Arizona
Phoenix, United States
City of Hope National Medical Center
Duarte, United States
Childrens Hospital Los Angeles
Los Angeles, United States
UCLA Medical Center
Los Angeles, United States
UCSF Medical Center
San Francisco, United States
Stanford University Medical Center
Stanford, United States
Emory University School of Medicine-Winship Cancer Institute
Atlanta, United States
Emory University School of Medicine/Winship Cancer Institute
Atlanta, United States

…and 112 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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