Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 30
SponsorSt. Jude Children's Research Hospital
About this trial
This study is being done to learn more about the short-term and long-term side effects of CAR-T cell therapy. Specifically, researchers want to know how often patients get infections, have delays in recovering blood cell counts and/or have damage to the nervous system.
Eligibility criteria
Qualifiers
Participants must have received an initial systemically-administered CAR T cell infusion within the last 1-3 months (+/- 14 days).
Initial infusion is defined as the first administration of a CAR T cell product the participant has not previously received OR receipt of a CAR T cell product previously received after an interval allogeneic HSCT.
Age ≤ 30 years at CAR T cell infusion.
Disqualifiers
Active malignancy other than the disease under study.
Planned consolidative HSCT within 3 months post CAR T cell infusion.
Received or planned additional disease directed therapy post CAR T cell infusion.
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
100 Participants
are grouped into 3 trial groupsLocations
6Colorado
Childrens Hospital of Colorado80045, Aurora United States
Pennsylvania
Children's Hospital of Philadelphia19104, Philadelphia United States
Tennessee
St. Jude Children's Research Hospital38105, Memphis United States
Utah
Primary Children's Hospital84113, Salt Lake City United States
Sponsors and collaborators
St. Jude Children's Research Hospital
Lead sponsor
Rally Foundation for Childhood Cancer Research
Collaborator
Source ClinicalTrials.gov