Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy
Purpose
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.
Conditions
- B-ALL
- Hematologic Malignancy
- Solid Tumor
Eligibility
- Eligible Ages
- Under 30 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| B cell acute lymphoblastic leukemia (B cell acute lymphoblastic leukemia (B-ALL) ) cohort | B-ALL participants who have received initial CAR T cell therapy within the last 1-3 months. | |
| Other hematologic malignancy | Other hematologic malignancy participants who have received initial CAR T cell therapy within the last 1-3 months. | |
| Solid tumor (ST) | ST participants who have received initial CAR T cell therapy within the last 1-3 months. |
Recruiting Locations
Memphis 4641239, Tennessee 4662168 38105
More Details
- Status
- Recruiting
- Sponsor
- St. Jude Children's Research Hospital
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.