Evaluating the delayed effects of CAR T cell therapy in children
Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy (PROSPER)
This study looks at the short-term and long-term side effects of CAR T cell therapy in children with certain types of cancer to see how it affects them over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | N/A to 30 Years |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Drugs / interventions | CAR T, CAR-T |
| Locations | 3 sites (Philadelphia, Pennsylvania and 2 other locations) |
| Trial ID | NCT06579469 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the short-term and long-term side effects of CAR T cell therapy in pediatric patients. Researchers will monitor the incidence and severity of bone marrow dysfunction, infections, and neurotoxicity at various intervals following treatment. Data will be collected at 3 months, 6 months, 1 year, and 2 years post-infusion, allowing for a comprehensive understanding of the therapy's delayed effects. The study focuses on patients with B-ALL, hematologic malignancies, and solid tumors.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 30 years or younger who have received their first CAR T cell infusion within the last 1-3 months.
Not a fit: Patients with active malignancies other than the one being treated or those planning additional therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety and long-term effects of CAR T cell therapy, improving patient management and outcomes.
How similar studies have performed: While there have been studies on CAR T cell therapy, this specific focus on delayed effects in pediatric populations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 disease directed therapy post CAR T cell infusion. * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Where this trial is running
Philadelphia, Pennsylvania and 2 other locations
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
- Children's Hospital of Wisconsin. — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Rebecca Epperly, MD — St. Jude Children's Research Hospital
- Study coordinator: Rebecca Epperly, MD
- Email: referralinfo@stjude.org
- Phone: 866-278-5833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.