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

NCT ID: NCT03375619

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2035-01-01

Brief Summary

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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

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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.

Conditions

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Chronic Lymphocytic Leukemia Lymphomas Non-Hodgkin's B-Cell Lymphoma, Small Lymphocytic Mantle Cell Lymphoma Central Nervous System Lymphoma Diffuse Large B Cell Lymphoma Follicular Lymphoma Burkitt Lymphoma Multiple Myeloma

Keywords

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CAR-T Cell Therapy chimeric antigen receptor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Long-Term Follow-Up of Participants who Received CAR-T cells

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All participants who enrolled in a CAR-T study at Froedtert Hospital \& the Medical College of Wisconsin.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Nirav Shah

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nirav Shah

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

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Froedtert Hospital & Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Medical College of Wisconsin Clinical Cancer Center

Role: CONTACT

Phone: 414-805-8900

Email: [email protected]

Facility Contacts

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Cancer Center Clinical Trials Office

Role: primary

Other Identifiers

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PRO30317

Identifier Type: -

Identifier Source: org_study_id