Clinical Trial

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

Study acronym: Lythesia
Recruiting
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Summary
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 assess a potential role of tisagenlecleucel in the development/oncogenesis of secondary malignancy of T-cell origin.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-04-15
notable Trial sites expanded: 0 -> 3 locations 2026-04-15
Trial Details
NCT Number NCT07378969
Lead Sponsor Novartis Pharmaceuticals
Conditions Secondary Malignancies of T-cell Origin
Enrollment 30 participants
Start Date 2026-03-23
Primary Completion 2039-08-31 (estimated)
Study Completion 2039-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-11