Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT06785818
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Follow up Local Registry Study of Kymriah in South Korea
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
A Registry to Assess Long-Term Safety of Patients With B-Lymphocyte Malignancies Treated With Tisagenlecleucel in South Korea
Status:
RECRUITING
Status Verified Date:
2025-11
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:
None
Brief Summary:
This study is multicenter, primary data collection, non-interventional registry study to assess long-term safety, secondary malignancy risk, and effectiveness of tisagenlecleucel in patients with B-cell malignancies in a routine clinical practice setting in Korea.
Detailed Description:
This study will inform on long-term real-world safety and effectiveness of tisagenlecleucel. The primary objective is to evaluate the long-term safety and the risk of secondary malignancies in patients with B lymphocyte malignancies treated with tisagenlecleucel in a real-world setting. The main secondary objective is to evaluate the longterm effectiveness of tisagenlecleucel.
All participants enrolled in this study will be followed up for 15 years from the time of Kymriah® infusion.
All participants enrolled in this study will be followed up for 15 years from the time of Kymriah® infusion.
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?: