Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:04 AM
Study NCT ID:
NCT07378969
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
A Non-Interventional Study (NIS) PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy (CCTL019B2402)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Lythesia
Brief 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.
Detailed Description:
The participant population will include individuals who have been treated either in the post-marketing/commercial setting (Cohort 2) or in the clinical trial setting (Cohort 1) but discontinued from the primary interventional study trials, did not move to the LTFU study, or discontinued from the long-term follow-up (LTFU) clinical trial CCTL019A2205B and have a confirmed secondary malignancy of T-cell origin.
The study will remain open for the enrollment of participants from Cohort 1 and Cohort 2 for up to approximately 15 years from the last indication approved for tisagenlecleucel.
The study will remain open for the enrollment of participants from Cohort 1 and Cohort 2 for up to approximately 15 years from the last indication approved for tisagenlecleucel.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: