Burkitt Lymphoma, Central Nervous System Lymphoma, Chronic Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Lymphoma, Small Lymphocytic, Lymphomas Non-Hodgkin's B-Cell, Mantle Cell Lymphoma, Multiple Myeloma
Conditions
Keywords
CAR-T Cell Therapy, chimeric antigen receptor
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.
Interventions
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* All participants who enrolled in a CAR-T study at Froedtert Hospital & the Medical College of Wisconsin.
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the incidence of a new malignancy at 5 years. | Baseline to five years. | The number of subjects with new malignancy. |
| Change from baseline in the incidence of a new malignancy at 10 years. | Baseline to 10 years. | The number of subjects with new malignancy. |
| Change from baseline in the incidence of a new malignancy at 15 years. | Baseline to 15 years. | The number of subjects with new malignancy. |
Countries
United States