Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy (NCT06579469) | Clinical Trial Compass
RecruitingNot Applicable
Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy
United States100 participantsStarted 2026-01-20
Plain-language 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.
Who can participate
Age range
30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is specifically tracking delayed effects after CAR T-cell therapy — like bone marrow dysfunction, serious infections, and neurological problems — does my child's treatment history make these long-term complications something we should be watching closely for?
2This trial is labeled 'Phase NA,' which suggests it's an observational study rather than testing a new treatment — can you explain what that means for my child in terms of what participation would actually involve day-to-day?
3The study lists 'persistent ICANS' as something it's measuring — what is ICANS, how likely is it to occur after the CAR T-cell therapy my child received or is considering, and how would we know if it's happening?
4Given that this study is focused on B-ALL, hematologic malignancies, and solid tumors, does my child's specific diagnosis fit the profile of patients this study is designed to follow, and would enrollment give us access to closer monitoring we wouldn't otherwise get?
5If we don't join this observational study, would my child still be monitored for bone marrow dysfunction and serious infections as part of their standard follow-up care, or is this trial an opportunity to get more thorough tracking of those risks?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Presence of bone marrow dysfunction (BMD)
Timeframe: Within 6 months post CAR T-cell therapy
2
Occurrence of clinically significant infections
Timeframe: Within 6 months post CAR T-cell therapy
3
Presence of persistent ICANS
Timeframe: Within 6 months post CAR T-cell therapy