Study Overview
This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.
Description
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.
Official Title
Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy
Quick Facts
Study Start:2016-01-05
Study Completion:2036-02-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
| Inclusion Criteria | Exclusion Criteria |
|---|
| |
Contacts and Locations
Study Locations (Sites)
Mayo Clinic Arizona
Phoenix, Arizona, 85054
United States
Childrens Hospital Los Angeles
Los Angeles, California, 90027
United States
UCSF Medical Center
San Francisco, California, 94143
United States
Stanford University Medical Center
Stanford, California, 94304
United States
Emory University School of Medicine/Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Childrens Healthcare of Atlanta
Atlanta, Georgia, 30342
United States
University of Chicago Medical Center, Hematology & Oncology
Chicago, Illinois, 60637
United States
University of Kansas Cancer Center SC
Westwood, Kansas, 66205
United States
Beth Israel Deaconess Medical Cente
Boston, Massachusetts, 02215
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
University of Michigan
Ann Arbor, Michigan, 48109-2800
United States
University of Michigan Health System SC CTL019
Ann Arbor, Michigan, 48109
United States
Children's Mercy Hospital SC
Kansas City, Missouri, 64108
United States
Weill Cornell Medical College
New York, New York, 10065
United States
Duke Unversity Medical Center SC - CTL019B2205J
Durham, North Carolina, 27705
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
United States
Ohio ST Compr Cancer Ctr James Hosp
Columbus, Ohio, 43210
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
The Childrens Hosp of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
UTSW/Children's Medical Center
Dallas, Texas, 75235
United States
MD Anderson Cancer Center SC
Houston, Texas, 77030
United States
University of Utah Clinical Trials Office
Salt Lake City, Utah, 84108
United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
United States
Collaborators and Investigators
Sponsor: Novartis Pharmaceuticals
- Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals
Study Record Dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
Study Start Date2016-01-05
Study Completion Date2036-02-22
Study Record Updates
Study Start Date2016-01-05
Study Completion Date2036-02-22
Terms related to this study
Additional Relevant MeSH Terms
- Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program