IRB #

IRB00011960

Title

Long Term Follow-Up of Patients Exposed to Lentiviral-
Based CD19 directed CART Cell Therapy

Principal Investigator

Brandon Hayes-Lattin

Study Purpose

The purpose of this study is to monitor all patients who have received CD19
CART therapy for the long term, for up to 15 years from the last CD19 CART cell therapy infusion. This study will continue to evaluate and monitor patients for safety issues that might be related to the study therapy, efficacy, and to comply with FDA regulations. Patients are evaluated in this study after they have either completed or discontinued early from their CD19 CART cell therapy treatment studies.

Medical Condition(s)

This protocol is for the long term follow up of patients treated with a qualifying CD19 CART cell therapy that they already received through other treatment protocols. Patients will have received the cell therapy as treatment for certain B cell malignancies.

Eligibility Criteria

Patients must have received a Novartis-sponsored CD19 CART cell therapy and completed or discontinued early from their CD19 CART therapy treatment study. Patients must have provided informed consent for this long term follow up study prior to their study participation. There are no specific exclusion criteria for this study.

Age Range

0 - 80

Healthy Volunteers Needed

No

Duration of Participation

15 years from date of last infusion of therapeutic T cells.

Minors Included

Yes

Contact

Clinical Trials Information Line: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

Novartis Pharmaceuticals

Recruitment End

01/01/2500

Compensation Provided

No


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