Long-term Follow-up Study of Patients Receiving CAR-T Cells
1 other identifier
observational
500
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 7, 2017
CompletedFirst Posted
Study publicly available on registry
December 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2035
November 10, 2025
November 1, 2025
17.1 years
December 7, 2017
November 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change from baseline in the incidence of a new malignancy at 5 years.
The number of subjects with new malignancy.
Baseline to five years.
Change from baseline in the incidence of a new malignancy at 10 years.
The number of subjects with new malignancy.
Baseline to 10 years.
Change from baseline in the incidence of a new malignancy at 15 years.
The number of subjects with new malignancy.
Baseline to 15 years.
Study Arms (1)
Participants who received CAR-T cells.
Participants who received CAR-T cells at Froedtert Hospital \& the Medical College of Wisconsin in clinical trials (e.g., NCT05976555, NCT05094206, NCT05990465, NCT03019055 or NCT04186520).
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.
Eligibility Criteria
All participants who enrolled in a CAR-T study at Froedtert Hospital \& the Medical College of Wisconsin.
You may qualify if:
- All participants who enrolled in a CAR-T study at Froedtert Hospital \& the Medical College of Wisconsin.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nirav Shah
Medical College of Wisconsin
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 7, 2017
First Posted
December 18, 2017
Study Start
December 1, 2017
Primary Completion (Estimated)
January 1, 2035
Study Completion (Estimated)
January 1, 2035
Last Updated
November 10, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share