A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy

Recruiting Observational Study
Secondary Malignancies of T-cell Origin
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
15 – 15
Sex
Any
Study type
Observational
Participants needed
30 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
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About This Trial
The study aims to provide an adequate procedural framework to support and facilitate collection of existing participant samples from patients who were diagnosed with secondary malignancy of T-cell origin any time after tisagenlecleucel treatment for testing of muCAR19 transgene and RCL, as well as additional analyses as warranted. Formal testing of existing tumor tissue and/or blood DNA will asses…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Study participants eligible for inclusion in this study must meet all of the following criteria: 1. Prior use of tisagenlecleucel treatment in CTL019 clinical trial setting or post-marketing/commercial tisagenlecleucel setting as outlined for Cohort 1 and Cohort 2 2. Confirmed …
Contacts

Novartis Pharmaceuticals

+81337978748

novartis.email@novartis.com

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Novartis Pharmaceuticals

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