Long-Term Safety and Effectiveness Study of Tisagenlecleucel for B-Cell Malignancies in South Korea

What this Trial Is About

Researchers are studying the long-term safety, risk of secondary cancers, and effectiveness of tisagenlecleucel in patients with B-cell malignancies treated in routine clinical practice in South Korea. This observational registry study collects primary data from multiple centers and follows participants for up to 15 years after receiving the treatment. The focus is on real-world outcomes to better understand the long-term effects of tisagenlecleucel in these patients. Participants included in this study have already been treated with tisagenlecleucel, and there is no new treatment given as part of the trial. The study observes patients who have received this therapy through commercial, managed access, or other pathways. No treatment allocation occurs since this is a non-interventional study, and the decision to use tisagenlecleucel is based on clinical judgment outside of the study protocol. During the 15-year follow-up, researchers will monitor participants for adverse events, secondary malignancies, and the presence of lentivirus in blood or tissues. They will assess long-term effectiveness outcomes such as response rates, duration of response, relapse-free and progression-free survival, and overall survival for different B-cell malignancies. Data collection includes safety monitoring and pregnancy outcomes. This extended observation aims to provide comprehensive information on the long-term impact of tisagenlecleucel treatment.

Long-term Follow up Local Registry Study of Kymriah in South Korea