Clinical trial · Observational
Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy
Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy (PROSPER)
NCT06579469CI-TRIAL-00115212recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-ALL | B Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- B cell acute lymphoblastic leukemia (B cell acute lymphoblastic leukemia (B-ALL) ) cohort
- description
- B-ALL participants who have received initial CAR T cell therapy within the last 1-3 months.
- label
- Other hematologic malignancy
- description
- Other hematologic malignancy participants who have received initial CAR T cell therapy within the last 1-3 months.
- label
- Solid tumor (ST)
- description
- ST participants who have received initial CAR T cell therapy within the last 1-3 months.
Primary outcomes (3)
- measure
- Presence of bone marrow dysfunction (BMD)
- timeFrame
- Within 6 months post CAR T-cell therapy
- description
- Among patients in remission or without bone marrow involvement of disease in the B-ALL cohort, we will summarize the rates of prevalent BMD at 3- and 6-months post-infusion and estimate the cumulative incidence of new BMD and BMD recovery for patients with prevalent BMD at 3- and 6-months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.