Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy (PROSPER)
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.
Detailed description
Primary Objectives * Bone Marrow Function: To report on the incidence, timing, severity of, and risk factors for bone marrow dysfunction in participants in remission or without bone marrow involvement of disease at 3- and 6-months following CAR T cell therapy. (B-ALL cohort) * Infection/Immune Reconstitution: To evaluate the incidence, timing, severity of and risk factors for clinically significant infections following CAR T cell therapy at 3- and 6-months following CAR T cell therapy. (B-ALL cohort) * Neurotoxicity: To evaluate the incidence, timing, severity of, and risk factors for persistent ICANS at 3- and 6-months post CAR T cell therapy. (B-ALL cohort) Secondary Objectives * To evaluate bone marrow function, infection/immune reconstitution, and neurotoxicity at 12 months and 24 months post CAR T cell therapy in participants with B-ALL. * To characterize bone marrow function, infection/immune reconstitution, and neurotoxicity between 3 and 24 months after CAR T cell therapy in other hematologic malignancies and solid tumor cohorts. 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.
Arms & interventions
Outcome measures
Primary
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
Secondary
Presence of bone marrow dysfunction (BMD)
Time frame: Within 24 months post CAR T-cell therapy
Severity of BMD
Time frame: Within 24 months post CAR T-cell therapy
Occurrence of clinically significant infections
Time frame: Within 24 months post CAR T-cell therapy
Time to the earliest clinically significant infection
Time frame: Within 24 months post CAR T-cell therapy
Severity of clinically significant infections
Time frame: Within 24 months post CAR T-cell therapy
Presence of persistent ICANS
Time frame: Within 24 months post CAR T-cell therapy
Severity of persistent ICANS
Time frame: Within 24 months post CAR T-cell therapy
Eligibility criteria
Study locations (6)
Childrens Hospital of Colorado
Aurora, Colorado, 80045
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Primary Children's Hospital
Salt Lake City, Utah, 84113
Seattle Childrens Hospital
Seattle, Washington, 98105
Children's Hospital of Wisconsin.
Milwaukee, Wisconsin, 53226