Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579469
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy PROSPER
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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
InfectionImmune 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 infectionimmune reconstitution and neurotoxicity at 12 months and 24 months post CAR T cell therapy in participants with B-ALL
To characterize bone marrow function infectionimmune 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
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
InfectionImmune 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 infectionimmune reconstitution and neurotoxicity at 12 months and 24 months post CAR T cell therapy in participants with B-ALL
To characterize bone marrow function infectionimmune 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None