Long-term Follow-up Study of Patients Receiving CAR-T Cells

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT03375619
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Long-Term Follow-Up of Participants who Received CAR-T cells — OTHER
    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.

Study Details

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)

Key Dates

First listed
Dec 18, 2017
Start date
Dec 1, 2017
Status verified
Nov 2025
Primary completion
Jan 1, 2035
Completion
Jan 1, 2035

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: 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).

Primary Outcome Measure

Change from baseline in the incidence of a new malignancy at 5 years. [ Time Frame: Baseline to five years. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert Hospital & Medical College of WisconsinMilwaukeeWisconsin53226
Cancer Center Clinical Trials Office
[email protected]
414-805-8900

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By research site
Froedtert Hospital & Medical College of Wisconsin· Milwaukee, WI

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