Long-term Follow-up Study of Patients Receiving CAR-T Cells
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Long-Term Follow-Up of Participants who Received CAR-T cells.
- Who it may be relevant to
- Registry conditions: Chronic Lymphocytic Leukemia, Lymphomas Non-Hodgkin's B-Cell, Lymphoma, Small Lymphocytic, Mantle Cell Lymphoma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Long-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.
Primary outcome measures
- Change from baseline in the incidence of a new malignancy at 5 years. [Time frame: Baseline to five years.]
- Change from baseline in the incidence of a new malignancy at 10 years. [Time frame: Baseline to 10 years.]
- Change from baseline in the incidence of a new malignancy at 15 years. [Time frame: Baseline to 15 years.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Froedtert Hospital & Medical College of Wisconsin — Milwaukee
Identifiers
NCT: NCT03375619 · PRO30317