Status:
RECRUITING
Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
Rally Foundation for Childhood Cancer Research
Conditions:
B-ALL
Hematologic Malignancy
Eligibility:
All Genders
Up to 30 years
Brief 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 r...
Detailed 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 involvemen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06579469
Start Date
January 1 2026
End Date
March 1 2029
Last Update
December 24 2025
Active Locations (2)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
2
Children's Hospital of Wisconsin.
Milwaukee, Wisconsin, United States, 53226