Long-Term Safety of CAR-T Cell Therapy
This study is looking at the long-term safety and effectiveness of a type of gene therapy called CAR-T cell therapy (Lentiviral-based CAR-T cell therapy). Health authorities require this study to monitor patients for up to 15 years after their last treatment. You can join if you have already received CAR-T cell therapy through a Novartis-sponsored trial or a University of Pennsylvania trial that Novartis is involved with. The study will track how many patients experience certain side effects over time, and also look for long-term effectiveness and how long the CAR-T cells stay in your body. This information helps us understand the benefits and risks of CAR-T therapies better.
- Study design
- This is an interventional study with a planned enrollment of 1400 participants, all of whom have previously received CAR-T cell therapy.
- What's involved
- You will be monitored for 15 years after your last CAR-T cell infusion, with assessments at specific intervals up to year 15.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 15 years after their last CAR-T cell infusion.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CAR-T Long Term Follow Up (LTFU) Study
At a glance
Conditions
NCT02445222
Where you'd take part
This study runs at 118 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Beth Israel Deaconess Med Center
Boston, Massachusettsstudy coordinator listed
Recruiting
Children s Mercy Hospital
Kansas City, Missouristudy coordinator listed
Recruiting
Children's Mercy Hospital SC
Kansas City, Missouristudy coordinator listed
Recruiting
Childrens Healthcare of Atlanta
Atlanta, Georgiastudy coordinator listed
Recruiting
Childrens Hospital Los Angeles
Los Angeles, Californiastudy coordinator listed
Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohiostudy coordinator listed
Recruiting
Cinn Children Hosp Medical Center
Cincinnati, Ohiostudy coordinator listed
Recruiting
Dana Farber Cancer Institute
Boston, Massachusettsstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals
Who to contact
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Inclusion
What this trial measures
- Percentage of patients with certain events (see description)at M3 post treatment, M6, M9, M12 and then, every 6M up to year 5, yearly until year 15.
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