Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: B-ALL, Hematologic Malignancy, Solid Tumor. Basic parameters: up to 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy (PROSPER)
Overview
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.
Primary outcome measures
- Presence of bone marrow dysfunction (BMD) [Time frame: Within 6 months post CAR T-cell therapy]
- Occurrence of clinically significant infections [Time frame: Within 6 months post CAR T-cell therapy]
- Presence of persistent ICANS [Time frame: Within 6 months post CAR T-cell therapy]
Secondary outcome measures (7)
- 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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 6 centers
- Childrens Hospital of Colorado — Aurora
- Children's Hospital of Philadelphia — Philadelphia
- St. Jude Children's Research Hospital — Memphis
- Primary Children's Hospital — Salt Lake City
- Seattle Childrens Hospital — Seattle
- Children's Hospital of Wisconsin. — Milwaukee
Identifiers
NCT: NCT06579469 · PROSPER · NCI-2024-06836