Long-term Follow-up Study of Patients Receiving CAR-T Cells
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.
Arms & interventions
- OtherLong-Term Follow-Up of Participants who Received CAR-T cells
No study drug is administered in this study. Participants who received CAR-T cells in a previous trial will be evaluated in this trial for long-term safety and efficacy.
Outcome measures
Primary
Change from baseline in the incidence of a new malignancy at 5 years.
The number of subjects with new malignancy.
Time frame: Baseline to five years.
Change from baseline in the incidence of a new malignancy at 10 years.
The number of subjects with new malignancy.
Time frame: Baseline to 10 years.
Change from baseline in the incidence of a new malignancy at 15 years.
The number of subjects with new malignancy.
Time frame: Baseline to 15 years.
Eligibility criteria
Study locations (1)
Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226