Subjects treated with an ACTR product may participate in this long-term follow-up study after the completion of the final scheduled visit in the parent clinical study or other investigational setting, such as compassionate use, named patient Investigational New Drug application, expanded access program, or equivalent setting. No investigational product or treatment will be administered in this study. These subjects will be followed for safety monitoring on a schedule of decreasing frequency through 15 years post-ACTR treatment, in accordance with US FDA Regulatory guidance pertaining to long-term safety follow-up for study subjects receiving recombinant DNA-containing investigational products.
Study Type
OBSERVATIONAL
Enrollment
22
Banner MD Anderson
Gilbert, Arizona, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
Yale University
New Haven, Connecticut, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, United States
Loyola University
Maywood, Illinois, United States
Indiana Bone and Marrow Transplantation
Indianapolis, Indiana, United States
University of Maryland
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
...and 6 more locations
Long-term safety of ACTR T cell product as assessed by overall survival
Time frame: Total of 15 years after first receiving an ACTR T cell product
Long-term safety of ACTR T cell product as assessed by serious adverse events related to ACTR T cell product
Time frame: Total of 15 years after first receiving an ACTR T cell product
Long-term safety of ACTR T cell product as assessed by Grade 3 or 4 adverse events related to ACTR T cell product
Time frame: Total of 15 years after first receiving an ACTR T cell product
Long-term safety of ACTR T cell product as assessed by adverse events of special interest, regardless of grade or relatedness to the ACTR T cell product
Time frame: Total of 15 years after first receiving an ACTR T cell product
ACTR T cell persistence in subjects previously treated with an ACTR T cell product
Time frame: Total of 15 years after first receiving an ACTR T cell product
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