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NCT03375619 Clinical Trial

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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03375619
Other study ID # PRO30317
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2017
Est. completion date January 1, 2035

Study information
Verified date October 2023
Source Medical College of Wisconsin
Contact Medical College of Wisconsin Clinical Cancer Center
Phone 414-805-8900
Email cccto@mcw.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date January 1, 2035
Est. primary completion date January 1, 2035
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
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 exclusion criteria for this study.

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Froedtert Hospital & Medical College of Wisconsin Milwaukee Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in the incidence of a new malignancy at 5 years. The number of subjects with new malignancy. Baseline to five years.
Primary Change from baseline in the incidence of a new malignancy at 10 years. The number of subjects with new malignancy. Baseline to 10 years.
Primary Change from baseline in the incidence of a new malignancy at 15 years. The number of subjects with new malignancy. Baseline to 15 years.
See also
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