CD19 CART Long Term Follow Up (LTFU) Study

Condition(s)
Leukemia Lymphoma

Age Group
0-9 years 10-17 years 18-26 years

Phase(s)
Other

Genetic Double Helix Genetic
Previously treated CART CD 19 patients
Trial Summary

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 CD19 directed CAR T-cells (CD19 CART) for 15 years following last CD19 CART (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.

Ages: Child, Adult, Older Adult
Condition: Safety LTFU, Pts Receiving CD19 Directed CAR T-Cell Therapy
Status
Recruiting
Location(s)
Mayo Clinic Arizona Mayo Clinic Building, Phoenix, AZ
Childrens Hospital Los Angeles SC CTL019, Los Angeles, CA
University of California San Francisco SC-4, San Francisco, CA
Emory University School of Medicine/Winship Cancer Institute, Atlanta, GA
Children's Healthcare of Atlanta SC CTL019, Atlanta, GA
University of Chicago Medical Center, Hematology & Oncology, Chicago, IL
University of Kansas Cancer Center SC, Westwood, KS
University of Michigan SC - CTL019B2205J, Ann Arbor, MI
University of Michigan Health System SC CTL019, Ann Arbor, MI
University of Minnesota SC-4, Minneapolis, MN
Children's Mercy Hospital SC, Kansas City, MO
Weill Cornell Medical College, New York, NY
Duke Unversity Medical Center SC - CTL019B2205J, Durham, NC
Cincinnati Children's Hospital Medical Center, Cincinnati, OH
Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State Univ., Columbus, OH
Oregon Health & Science University, Portland, OR
The Childrens Hospital of Philadelphia (CHOP), Philadelphia, PA
University of Pennsylvania, Philadelphia, PA
UTSW/Children's Medical Center, Dallas, TX
MD Anderson Cancer Center SC, Houston, TX
University of Utah Clinical Trials Office, Salt Lake City, UT
University of Wisconsin Hospital and Clinics, Madison, WI
Novartis Investigative Site, Melbourne, Victoria, Australia
Novartis Investigative Site, Parkville, Victoria, Australia
Novartis Investigative Site, Camperdown, Australia
Novartis Investigative Site, Vienna, Austria
Novartis Investigative Site, Hamilton, Ontario, Canada
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Paris Cedex 10, France
Novartis Investigative Site, Paris Cedex 19, France
Novartis Investigative Site, Koeln, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Frankfurt, Germany
Novartis Investigative Site, Wurzburg, Germany
Novartis Investigative Site, Amsterdam, Netherlands
Novartis Investigative Site, Esplugues de Llobregat, Barcelona, Spain
Contact
Novartis Pharmaceuticals
888-669-6682