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Clinical Trial Summary

This will be a multicenter, national, non-interventional, prospective cohort study


Clinical Trial Description

Eligible participants will be pediatric (<18 years) and adult patients (aged 18 years or older) with B-cell malignancies who have received tisagenlecleucel through the commercial setting or out-of-specification (OOS) use in Brazil. We will collect data prospectively and complement missing information with retrospective data collection, when necessary. It is anticipated that approximately 200 patients will be enrolled in the cohort over 5 years divided among the study indications. Since this is a non-interventional study, no administration of study drug or application of questionnaires will be mandated by this protocol. The study will consist of a "Pre-infusion" and a "Post infusion follow-up period" for up to 15 years post tisagenlecleucel infusion. All patients will be followed until death or last scheduled visit, whichever comes first. For the study, "pre-infusion" and "follow-up post infusion" phases are defined as: - "Pre-infusion" will consist of the patient's information from the time of diagnosis untiljust prior to infusion with tisagenlecleucel. - "Follow-up Post infusion" information will comprise any information from the infusionof tisagenlecleucel onwards. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05541341
Study type Observational
Source Novartis
Contact Novartis Pharmaceuticals
Phone +41613241111
Email novartis.email@novartis.com
Status Recruiting
Phase
Start date November 24, 2023
Completion date December 16, 2038

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