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A Registry to Assess Long-Term Safety of Patients With B-Lymphocyte Malignancies Treated With Tisagenlecleucel in South Korea
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.
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.
Age
0 - 100 years
Sex
ALL
Healthy Volunteers
No
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, South Korea
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, South Korea
Novartis Investigative Site
Gyeonggi-do, Korea, South Korea
Novartis Investigative Site
Incheon, Korea, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, Seoul, South Korea
Novartis Investigative Site
Seoul, Seoul, South Korea
Novartis Investigative Site
Busan, South Korea
Start Date
March 12, 2025
Primary Completion Date
December 30, 2039
Completion Date
December 30, 2039
Last Updated
February 23, 2026
500
ESTIMATED participants
Tisagenlecleucel
OTHER
Novartis Pharmaceuticals
CONTACT
Lead Sponsor
Novartis Pharmaceuticals
Data Source & Attribution
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