Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy
NCT Number: NCT06579469
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: B-ALL|Hematologic Malignancy|Solid Tumor
Sponsor: St. Jude Children's Research Hospital
Collaborators: Rally Foundation for Childhood Cancer Research
Sex: ALL
Age: CHILD, ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2029-02
Locations: St. Jude Children's Research Hospital, Memphis, Tennessee, 38105, United States

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.

Primary Outcome Measures: 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., 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., 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., Within 6 months post CAR T-cell therapy
Secondary Outcome Measures: 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., 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., 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., 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., 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., 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., 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., Within 24 months post CAR T-cell therapy