Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy (PROSPER)
St. Jude Children's Research Hospital
Summary
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.
Description
Primary Objectives * Bone Marrow Function: To report on the incidence, timing, severity of, and risk factors for bone marrow dysfunction in participants in remission or without bone marrow involvement of disease at 3- and 6-months following CAR T cell therapy. (B-ALL cohort) * Infection/Immune Reconstitution: To evaluate the incidence, timing, severity of and risk factors for clinically significant infections following CAR T cell therapy at 3- and 6-months following CAR T cell therapy. (B-ALL cohort) * Neurotoxicity: To evaluate the incidence, timing, severity of, and risk factors for persist…
Eligibility
- Age range
- Up to 30 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * Active malignancy other than the disease under study. * Planned consolidative HSCT within 3 months post CAR T cell infusion. * Received or planned additional dise…
Locations (3)
- Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania
- St. Jude Children's Research HospitalMemphis, Tennessee
- Children's Hospital of Wisconsin.Milwaukee, Wisconsin