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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorMedical College of Wisconsin

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

There are no exclusion criteria for this study.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Participants who received CAR-T cells.1 intervention

Trial outcomes

Primary outcomes

1

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

The number of subjects with new malignancy.

Time frame
Baseline to five years.
2

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

The number of subjects with new malignancy.

Time frame
Baseline to 10 years.
3

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

The number of subjects with new malignancy.

Time frame
Baseline to 15 years.

Secondary outcomes

Other outcomes

Sponsors and contacts

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