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CAR-T Long Term Follow Up (LTFU) Study
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 0 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2016-01-05
Primary completion: 2036-02-22
Study completion finish: 2036-02-22
Study type
OTHER
Phase
PHASE3
Trial ID
NCT02445222
Intervention or treatment
GENETIC: Previously treated CAR-T patients
Conditions
- • Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
Find a site
Closest Location:
Novartis Investigative Site
Research sites nearby
Select from list below to view details:
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Parkville, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
OTHER: Previously treated CAR-T patients
| GENETIC: Previously treated CAR-T patients
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Percentage of patients with certain events (see description) | The percentage of pts with listed categories: New secondary malignancies, new serious infection, new incidence of serious neurologic disorder, New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder, New incidence of a hematologic disorder | at M3 post treatment, M6, M9, M12 and then, every 6M up to year 5, yearly until year 15. |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Percentage of patients with detectable CAR transgene levels in peripheral blood by q-PCR at pre- specified time points | Not Specified | at M3 post treatment, M6, M9, M12 and every 6M up to year 5, yearly until year 15. |
Percentage of patients with detectable RCL by VSV-G | Not Specified | at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15 |
Percentage of patients who relapse or progress among patients who had not relapsed or progressed at study entry/re-entry;Incidence of death | Not Specified | at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15. |
B- and T- lymphocyte count | Not Specified | at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15. |
Height and weight, Tanner staging, menstruation status | Not Specified | at M3 post treatment then M6, M12 and every year until year 15. |
Frequently Asked Questions
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