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 Sex
- 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
Duarte 5344147, California 5332921 91010 3000
Los Angeles 5368361, California 5332921 90027
Los Angeles 5368361, California 5332921 90095
310-825-4493
San Francisco 5391959, California 5332921 94143
Stanford 5398563, California 5332921 94304
Atlanta 4180439, Georgia 4197000 30322
Atlanta 4180439, Georgia 4197000 30322
Atlanta 4180439, Georgia 4197000 30342
Chicago 4887398, Illinois 4896861 60637
Chicago 4887398, Illinois 4896861 60637
Westwood 4281639, Kansas 4273857 66205
Westwood 4281639, Kansas 4273857 66205
Boston 4930956, Massachusetts 6254926 02114
Boston 4930956, Massachusetts 6254926 02215
617-667-7000
Boston 4930956, Massachusetts 6254926 02215
617-632-3985
Ann Arbor 4984247, Michigan 5001836 48109-2800
Ann Arbor 4984247, Michigan 5001836 48109
Ann Arbor 4984247, Michigan 5001836 48109
Detroit 4990729, Michigan 5001836 48201
313-576-8716
Kansas City 4393217, Missouri 4398678 64108
Kansas City 4393217, Missouri 4398678 64108
Durham 4464368, North Carolina 4482348 27705
Durham 4464368, North Carolina 4482348 27705
Cincinnati 4508722, Ohio 5165418 45229-3039
Cincinnati 4508722, Ohio 5165418 45229-3039
Columbus 4509177, Ohio 5165418 43210
Portland 5746545, Oregon 5744337 97239
Portland 5746545, Oregon 5744337 97239
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19107
215-955-8699
Nashville 4644585, Tennessee 4662168 37203
Dallas 4684888, Texas 4736286 75235
Dallas 4684888, Texas 4736286 75390
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Salt Lake City 5780993, Utah 5549030 84108
Salt Lake City 5780993, Utah 5549030 84108
Madison 5261457, Wisconsin 5279468 53792
Madison 5261457, Wisconsin 5279468 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.