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NCT Number: NCT03375619

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

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)

Recruiting

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Key information

Conditions

Chronic Lymphocytic Leukemia Blood Protein Disorders Burkitt Lymphoma Cardiovascular Diseases Central Nervous System Lymphoma Chronic Disease DNA Virus Infections Diffuse Large B Cell Lymphoma Disease Attributes Epstein-Barr Virus Infections Follicular Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, Small Lymphocytic Lymphomas Non-Hodgkin's B-Cell Lymphoproliferative Disorders Mantle Cell Lymphoma Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Tumor Virus Infections Vascular Diseases Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Froedtert Hospital & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location status: Recruiting

Location contact

Cancer Center Clinical Trials Office

CONTACT

[email protected]

414-805-8900

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change from baseline in the incidence of a new malignancy at 5 years.

    Time frame: Baseline to five years.

    The number of subjects with new malignancy.

  2. Change from baseline in the incidence of a new malignancy at 10 years.

    Time frame: Baseline to 10 years.

    The number of subjects with new malignancy.

  3. Change from baseline in the incidence of a new malignancy at 15 years.

    Time frame: Baseline to 15 years.

    The number of subjects with new malignancy.

Study contacts

Contact information is provided by the study sponsor or research team.

Medical College of Wisconsin Clinical Cancer Center

CONTACT

[email protected]

414-805-8900

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Important dates

Study start
2017
Primary completion
2035
Study completion
2035
First posted
Dec 18, 2017
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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