An observational study in B-ALL, Hematologic Malignancy and Solid Tumor, sponsored by St. Jude Children's Research Hospital. Recruiting at 6 sites in United States. Open to participants aged Up to 30 Years. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by St. Jude Children's Research Hospital · Observational
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.
Primary Objectives
Secondary Objectives
Participants will have an assessment of preexisting morbidity and potential risk factors, collection of specimens for banking, scheduled late effects monitoring, laboratory analysis, and screening studies. Data and biospecimens will be collected at 3 months, 6 months, 1 year and 2 years after CAR T cell infusion.
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's planned enrollment of 100 is below the median of 186 across 326 observational studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants who have received CAR T cell therapy
Participants must have received an initial systemically-administered CAR T cell infusion within the last 1-3 months (+/- 14 days).
Exclusion Criteria:
B-ALL participants who have received initial CAR T cell therapy within the last 1-3 months.
Other hematologic malignancy participants who have received initial CAR T cell therapy within the last 1-3 months.
ST participants who have received initial CAR T cell therapy within the last 1-3 months.
Presence of bone marrow dysfunction (BMD)
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.
Time frame: Within 6 months post CAR T-cell therapy
Occurrence of clinically significant infections
The infection density of clinically significant infections in 3-6 months will be summarized in the B-ALL cohort.
Time frame: Within 6 months post CAR T-cell therapy
Presence of persistent ICANS
We will summarize the rates of persistent ICANS at 3- and 6-months post-infusion and estimate the cumulative incidence and timing of new ICANS and ICANS recovery for patients with persistent ICANS at 3- and 6-months in the B-ALL cohort.
Time frame: Within 6 months post CAR T-cell therapy
Presence of bone marrow dysfunction (BMD)
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 12- and 24-months post-infusion and estimate the cumulative incidence of new BMD and BMD recovery for patients with prevalent BMD at 12- and 24-months. Analyses will be replicated in the other hematologic malignancies and solid tumor cohorts.
Time frame: Within 24 months post CAR T-cell therapy
Severity of BMD
The highest severity BMD for each patient will be recorded. The severity of BMD in the B-ALL cohort will be described using descriptive statistics. Analyses will be replicated in the other hematologic malignancies and solid tumor cohorts.
Time frame: Within 24 months post CAR T-cell therapy
Occurrence of clinically significant infections
The infection density of clinically significant infections within 24 months will be summarized in the B-ALL cohort. Analyses will be replicated in the other hematologic malignancies and solid tumor cohorts.
Time frame: Within 24 months post CAR T-cell therapy
Time to the earliest clinically significant infection
The time from 3 months post-infusion to the first clinically significant post-infusion within 24 months post-infusion will be summarized in the B-ALL cohort. The cumulative incidence of the first clinically significant infection post-infusion within 24 months will be estimated in B-ALL cohort. Analyses will be replicated in the other hematologic malignancies and solid tumor cohorts.
Time frame: Within 24 months post CAR T-cell therapy
Severity of clinically significant infections
The highest severity among all clinically significant infections for each patient will be summarized. The severity of clinically significant infections in the B-ALL cohort will be described. Analyses will be replicated in the other hematologic malignancies and solid tumor cohorts.
Time frame: Within 24 months post CAR T-cell therapy
Presence of persistent ICANS
We will summarize the rates of persistent ICANS at 12- and 24-months post-infusion and estimate the cumulative incidence and timing of new ICANS and ICANS recovery for patients with persistent ICANS at 12- and 24-months in B-ALL cohort. Analyses will be replicated in the other hematologic malignancies and solid tumor cohorts.
Time frame: Within 24 months post CAR T-cell therapy
Severity of persistent ICANS
The highest severity of ICANS for each patient will be recorded. The severity of ICANS in the B-ALL cohort will be described using descriptive statistics. Analyses will be replicated in the other hematologic malignancies and solid tumor cohorts.
Time frame: Within 24 months post CAR T-cell therapy
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