Long-term Follow-up Study of Patients Receiving CAR-T Cells
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Lymphocytic Leukemia
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Change from baseline in the incidence of a new malignancy at 5 years.
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
This protocol is designed as a long-term follow-up study of participants who will receive CAR-T cells as part of a clinical trial at the Medical College of Wisconsin/ Froedtert Hospital. The clinical trials include the following:
Phase 1 Study of CAR-20/19-T Cells in Patients with Relapsed Refractory B Cell Malignancies (NCT03019055); Phase I Trial of BCMA-TGF-BETA CAR-T Cells in Relapsed, Refractory Myeloma (NCT05976555); CAR20.19.22 T-cells in Relapsed, Refractory B-cell Malignancies (NCT05094206); LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies (NCT05990465); CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies (NCT04186520)
Detailed Description
The objective is to follow participants receiving CAR-T cells from years 2 to 15 post-treatment for persistence of CAR-T cells, development of secondary malignancies, or other medical complications.
Investigators
Nirav Shah
Associate Professor
Medical College of Wisconsin
Eligibility Criteria
Inclusion Criteria
- •All participants who enrolled in a CAR-T study at Froedtert Hospital \& the Medical College of Wisconsin.
Exclusion Criteria
- •There are no exclusion criteria for this study.
Outcomes
Primary Outcomes
Change from baseline in the incidence of a new malignancy at 5 years.
Time Frame: Baseline to five years.
The number of subjects with new malignancy.
Change from baseline in the incidence of a new malignancy at 10 years.
Time Frame: Baseline to 10 years.
The number of subjects with new malignancy.
Change from baseline in the incidence of a new malignancy at 15 years.
Time Frame: Baseline to 15 years.
The number of subjects with new malignancy.