CAR-T Long Term Follow Up (LTFU) Study
Purpose
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.
Condition
- Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
Eligibility
- Eligible Ages
- Between 0 Years and 100 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion 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 .
Exclusion Criteria
- There are no specific exclusion criteria for this study.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Previously treated CAR-T patients |
Patients who previously were exposed to lentiviral-based CART cell therapy |
|
Recruiting Locations
Los Angeles, California 90027
San Francisco, California 94143
Stanford, California 94304
Atlanta, Georgia 30322
Atlanta, Georgia 30342
Chicago, Illinois 60637
Westwood, Kansas 66205
Boston, Massachusetts 02215
617-667-7000
Boston, Massachusetts 02215
617-632-3985
Ann Arbor, Michigan 48109-2800
Ann Arbor, Michigan 48109
Kansas City, Missouri 64108
Durham, North Carolina 27705
Cincinnati, Ohio 45229-3039
Columbus, Ohio 43210
Portland, Oregon 97239
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Dallas, Texas 75235
Houston, Texas 77030
Salt Lake City, Utah 84108
Madison, Wisconsin 53792
More Details
- NCT ID
- NCT02445222
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
Study Contact
Novartis Pharmaceuticals1-888-669-6682
Detailed Description
Patients are enrolled following completion or early discontinuation from a Novartis sponsored or supported study of CAR T-Cell treatment. Patients will be followed for 15 years post treatment from the last treatment. They will be monitored for safety and efficacy within the primary treatment protocols for the protocol defined duration. Patients can drop off treatment protocols at any time to enter this long term Follow up study. Patients discontinuing from the primary treatment protocols for any reason will be enrolled in this long term follow up (LTFU). This will allow collecting data on long term safety and efficacy (as applicable) as mandated by the health authorities of all patients treated with CAR-T therapy within the concept of a single protocol. Collection of such long term effects of CAR-T cell therapy will help to further define the risk-benefit profile of CAR-T Therapies.