CAR-T Long Term Follow Up (LTFU) Study

Description

Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.

Conditions

Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program

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Study Overview

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Study Details

Study overview

Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.

Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy

CAR-T Long Term Follow Up (LTFU) Study

Condition
Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
Intervention / Treatment

-

Contacts and Locations

Phoenix

Mayo Clinic Arizona, Phoenix, Arizona, United States, 85054

Los Angeles

Childrens Hospital Los Angeles, Los Angeles, California, United States, 90027

San Francisco

UCSF Medical Center, San Francisco, California, United States, 94143

Stanford

Stanford University Medical Center, Stanford, California, United States, 94304

Atlanta

Emory University School of Medicine/Winship Cancer Institute, Atlanta, Georgia, United States, 30322

Atlanta

Childrens Healthcare of Atlanta, Atlanta, Georgia, United States, 30342

Chicago

University of Chicago Medical Center, Hematology & Oncology, Chicago, Illinois, United States, 60637

Westwood

University of Kansas Cancer Center SC, Westwood, Kansas, United States, 66205

Boston

Beth Israel Deaconess Medical Cente, Boston, Massachusetts, United States, 02215

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * All patients who have received a CAR-T therapy and completed or discontinued early from a Novartis sponsored treatment protocol that utilized CAR-T cells or from any CAR-T trial sponsored by the University of Pennsylvania with which Novartis has a contractual agreement to co-develop the CAR technology.
  • * Patients who have provided informed consent for the long term follow up study prior to their study participation .
  • * There are no specific exclusion criteria for this study.

Ages Eligible for Study

0 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2036-02-22