NCT06785818

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

A Registry to Assess Long-Term Safety of Patients With B-Lymphocyte Malignancies Treated With Tisagenlecleucel in South Korea

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 0 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• B-Cell Acute Lymphoblastic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma

Interventions

Type	Name	Description
OTHER	Tisagenlecleucel	This is an observational study. There is no treatment allocation. The decision to initiate tisagenlecleucel will be based solely on clinical judgement.

Timeline

• Start date: 2025-03-12
• Primary completion: 2039-12-30
• Completion: 2039-12-30
• First posted: 2025-01-21
• Last updated: 2026-02-23

Locations

16 sites across 1 country: South Korea