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

Recruiting

• Conditions: Mantle Cell Lymphoma; Central Nervous System Lymphoma; Lymphomas Non-Hodgkin's B-Cell; Diffuse Large B Cell Lymphoma; Chronic Lymphocytic Leukemia; Burkitt Lymphoma; Multiple Myeloma; Lymphoma, Small Lymphocytic; Follicular Lymphoma
• Interventions: Other: Long-Term Follow-Up of Participants who Received CAR-T cells

• Registration Number: NCT03375619
• Lead Sponsor: Medical College of Wisconsin

Brief 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)

Detailed 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.

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-18
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Primary Completion: 2035-01-01
• Study Completion: 2035-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants who received CAR-T cells.	Long-Term Follow-Up of 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 Measures

Name	Time	Method
Change from baseline in the incidence of a new malignancy at 5 years.	Baseline to five years.	The number of subjects with new malignancy.
Change from baseline in the incidence of a new malignancy at 10 years.	Baseline to 10 years.	The number of subjects with new malignancy.
Change from baseline in the incidence of a new malignancy at 15 years.	Baseline to 15 years.	The number of subjects with new malignancy.

Trial Locations

Locations (1)

Froedtert Hospital & Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States