CAR-T Long Term Follow Up (LTFU) Study
Recruiting now · Phase 3
Conditions studied: Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
In brief
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.
Key facts
- Study ID
- NCT02445222
- Run by
- Novartis Pharmaceuticals
- People needed
- 1400
- Starts
- 2015-11-02
- Expected to finish
- 2036-02-22
- Last updated by the study team
- 2025-10-28
Who can join
Age: any, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 .
You may not qualify if…
- There are no specific exclusion criteria for this study.
Where it is running
- Duke Unversity Medical Center — Durham, North Carolina, United States (enrolling)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
- UCLA Medical Center — Los Angeles, California, United States (enrolling)
- City of Hope National Medical Center — Duarte, California, United States (enrolling)
- Childrens Hospital Los Angeles — Los Angeles, California, United States (enrolling)
- Emory University School of Medicine-Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
- Emory University School of Medicine/Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
- Childrens Healthcare of Atlanta — Atlanta, Georgia, United States (enrolling)
- UCSF Medical Center — San Francisco, California, United States (enrolling)
- University of Chicago Medical Center, Hematology & Oncology — Chicago, Illinois, United States (enrolling)
- Stanford University Medical Center — Stanford, California, United States (enrolling)
- University of Kansas Cancer Center — Westwood, Kansas, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Beth Israel Deaconess Med Center — Boston, Massachusetts, United States (enrolling)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- University of Michigan — Ann Arbor, Michigan, United States (enrolling)
- Uni Of Michigan Health System — Ann Arbor, Michigan, United States (enrolling)
- University of Michigan Health System SC CTL019 — Ann Arbor, Michigan, United States (enrolling)
- Wayne State University-Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
- Uni of Chi Medi Ctr Hema and Onco — Chicago, Illinois, United States (enrolling)
- Children s Mercy Hospital — Kansas City, Missouri, United States (enrolling)
- Children's Mercy Hospital SC — Kansas City, Missouri, United States (enrolling)
- University of Kansas Cancer Center SC — Westwood, Kansas, United States (enrolling)
- Duke Unversity Medical Center SC - CTL019B2205J — Durham, North Carolina, United States (enrolling)
- Cinn Children Hosp Medical Center — Cincinnati, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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