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Protocol No. UW14108
Principal Investigator Capitini, Christian
Age Group Both
Sponsor Type Industry
Title Long Term Follow-Up of Patients Exposed to Lentiviral-Based CD19 directed CART Cell Therapy (CCTL019A2205B)
Objective The purpose of this trial is to look at the long term effects of the CD19 CART therapy. This will help us find out if there are safety issues related to CD19 CART therapy that may develop years after treatment.
Treatment There is no study treatment in this long term follow up study.
Description It will require 13 visits to the office/clinic/study site over the first 5 years since your last CD19 CART therapy. Each visit should take 1 to 2 hours. From year 6 through 15 you will only be asked to come to the clinic for an annual visit if you continue to have detectable CD19 CAR transgene (a marker of your previous CD19 CART therapy). If CD19 CAR transgene is not detected anymore, you will be followed up by the study staff either via calls or mailings. Regardless of CD19 CAR transgene status, you will be followed every 6 months for the status of the disease. You will be provided with a list of medications and symptoms/medical conditions that have to be reported to the Heath Authorities during this long term follow up study. Should you suffer any of these symptoms/medical conditions or take any of these medications, it is very important that you inform the study staff even outside the visits.
- All patients who have received CD19 CAR T-cell therapy, murine (CTL019) and/or humanized (CTL119) CD19-directed CAR T cell treatment, manufactured by Novartis or Penn and participated in a Novartis or Penn sponsored treatment protocol or a Novartis managed access program. All patients will be included upon completion of the core study or early discontinuation
Applicable Disease Sites Leukemia
Participating Institutions UW Hospital and Clinics