Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 30
SponsorSt. Jude Children's Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Participants who have received CAR T cell therapy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 3 trial groupsGroup A: B cell acute lymphoblastic leukemia (B cell acute lymphoblastic leukemia (B-ALL) ) cohort
Group B: Other hematologic malignancy
Group C: Solid tumor (ST)
Trial outcomes
Primary outcomes
1
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 therapy2
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 therapy3
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 therapySecondary outcomes
1
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 therapy2
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 therapy3
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 therapy4
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 therapySponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Jude Children's Research Hospital
Lead sponsor
Rally Foundation for Childhood Cancer Research
Collaborator
Source ClinicalTrials.gov